Drugs / insulin glargine
insulin glargine
also known as
Lantus · glargine · IGlar · HOE901 · Gla-300 · Gla-100 · Glargine insulin · HOE901 - U100 · +44 more
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diabetes mellitus 2 milestones | |||||
| Filed | EU (EMA) | — | diabetes mellitus | 2023-08-21 | “submitted the Marketing Authorization Application (hereinafter referred to as "MAA") of Insulin glargine biosimilar to the European Medicines Agency (hereinafter referred to as "EMA").” ganlee.com ↗ |
| Filed | US (FDA) | — | diabetes mellitus | 2023-02-23 | “the submission of Biologics License Application (hereinafter referred to as "BLA") of insulin glargine injection, a proposed biosimilar drug developed by the company for the...” ganlee.com ↗ |
| Filed diabetes mellitus, noninsulin-dependent, 2 3 milestones | |||||
| Filed | US (FDA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2016-08-05 | “accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic 1 insulin glargine candidate” merck.com ↗ |
| Filed | EU (EMA) | — | diabetes mellitus, noninsulin-dependent, 2 | 2013-07-08 | “LY2963016 is a new insulin glargine product and has been filed through the EMA's biosimilar pathway.” lilly.com ↗ |
| Filed | Japan (PMDA) | — | diabetes mellitus, noninsulin-dependent, 2 | — | “This new insulin glargine product was also submitted in Japan.” lilly.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansion | US (FDA) | TOUJEO SOLOSTAR | — | 2019-11-26 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | LANTUS SOLOSTAR | — | 2003-05-01 – 2015-07-17 | fda.gov ↗ |
| Approved | EU (EMA) | Lantus | — | 2000-06-09 | europa.eu ↗ |
| Approved | US (FDA) | LANTUS SOLOSTAR | — | 2000-04-20 | fda.gov ↗ |
| Filed | China (NMPA) | — | — | — | “Notably, THDB’s insulin glargine has been filed for commercial approval in China” adocia.com ↗ “Notably, insulin glargine is already filed for commercial approval in China” adocia.com ↗ |
Trials 275 · started per year
today
US approved 2000
EU approved 2000
1
8
11
16
13
16
15
9
11
15
20
21
13
10
11
17
17
6
11
8
4
5
8
1
5
3
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02587741 | Jul 2015 → Jul 2023 | diabetic retinopathy | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 131 trials · 4 met primary · 1 missed | ||||||
| Phase 1 | NCT03945656 | May 2019 → Sep 2021 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03723772 | Nov 2018 → Jun 2020 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03555305 | Sep 2018 → Nov 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04236895 | Jul → Nov 2018 | type 1 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | Met primary |
| Phase 1 | NCT02713477 | Apr → Jun 2016 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 1 | NCT02506647 | Dec 2015 → Sep 2016 | type 1 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1 | NCT02479022 | Jun → Dec 2015 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02201199 | Aug → Nov 2014 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01981031 | Nov → Dec 2013 | type 1 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Phase 1 | NCT01838083 | Apr → Aug 2013 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01809184 | Mar → Sep 2013 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01704417 | Oct 2012 → Mar 2013 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01730014 | Oct 2012 → Jul 2013 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01676233 | Sep 2012 → Aug 2013 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01688635 | Sep 2012 → Feb 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01634165 | Jul → Sep 2012 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01597713 | May → Oct 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01493115 | Nov 2011 → Apr 2012 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01476345 | Nov 2011 → Jul 2012 | diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01357603 | Jun 2011 → May 2012 | type 1 diabetes mellitus | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT01334034 | Apr → Sep 2011 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01195454 | Aug → Nov 2010 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01146678 | Jun → Sep 2010 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01002768 | Oct 2009 → Mar 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 1 | NCT00961324 | Jul → Oct 2009 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 1 | NCT01868529 | Jan → Jun 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00824668 | Aug → Oct 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00574912 | Mar 2007 → Sep 2009 | type 2 diabetes mellitus | Vanderbilt University Medical Center | Completed | Met primary |
| Phase 1 | NCT01497574 | May → Oct 2005 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00184613 | May 2005 → Jan 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00348972 | Feb 2002 → ? | diabetes mellitus, hyperglycemia | Sanofi | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01053728 | Feb → May 2010 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT07461103 | Jun 2024 → Aug 2025 | pemphigus vulgaris | Alexandria University | Completed | No outcome recorded |
| Phase 2 | NCT05155917 | Mar 2022 → Jan 2024 | diabetic ketoacidosis, hyperglycemia | Changhua Christian Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04542148 | Feb 2022 → Nov 2025 overdue | gestational diabetes, type 2 diabetes mellitus | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04591457 | Oct 2020 → Aug 2021 | diabetes mellitus | Indonesia University | Unknown | No outcome recorded |
| Phase 2 | NCT03352674 | Sep 2016 → Dec 2018 | type 2 diabetes mellitus | Indonesia University | Completed | No outcome recorded |
| Phase 2 | NCT01910194 | Dec 2013 → Oct 2014 | diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01399645 | May 2011 → Jun 2014 | NAFLD1, metabolic dysfunction-associated steatohepatitis, type 2 diabetes mellitus | University of Montreal Hospital Centre (CHUM) | Completed | No outcome recorded |
| Phase 2 | NCT01049412 | Jan → Dec 2010 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00764556 | May 2008 → May 2009 | chronic obstructive pulmonary disease, hyperglycemia | St George's, University of London | Completed | No outcome recorded |
| Phase 2 | NCT00612040 | Jan → Jun 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 373 trials · 23 met primary · 5 missed | ||||||
| Phase 3 | NCT06881264 | Apr 2024 → Sep 2025 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06340854 | Apr 2024 → May 2025 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT06269107 | Feb 2024 → May 2025 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT05545800 | Sep 2022 → Jun 2024 | type 2 diabetes mellitus | Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 3 | NCT05514535 | Aug 2022 → Mar 2025 | obesity disorder, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT04310280 | Jun → Dec 2019 | chronic venous insufficiency, ulcer of lower limbs | Hospital Central "Dr. Ignacio Morones Prieto" | Completed | No outcome recorded |
| Phase 3 | NCT03767543 | Mar 2019 → Oct 2020 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT04022993 | Jul 2018 → Feb 2019 | type 1 diabetes mellitus | Geropharm | Completed | No outcome recorded |
| Phase 3 | NCT03371082 | Oct 2017 → Aug 2019 | type 1 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 3 | NCT03130426 | Jun 2017 → Jun 2019 | type 2 diabetes mellitus | Population Health Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT02855684 | Aug 2016 → Aug 2018 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02623998 | Jul 2016 → Sep 2018 | type 2 diabetes mellitus | Population Health Research Institute | Completed | Missed primary |
| Phase 3 | NCT02787551 | Jul 2016 → May 2018 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT02752412 | May 2016 → Oct 2018 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT02749890 | May 2016 → May 2018 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT02735044 | Apr 2016 → May 2018 | type 1 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT02666430 | Dec 2015 → Mar 2017 | type 1 diabetes mellitus | Mylan Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02585674 | Dec 2015 → Nov 2016 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02607943 | Dec 2015 → Jul 2018 | hyperglycemia, stroke disorder | National Taiwan University Hospital | Unknown | Missed primary |
| Phase 3 | NCT02401243 | Mar 2015 → Feb 2016 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02320721 | Jan 2015 → May 2016 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02168491 | Nov 2014 → Jul 2015 | type 2 diabetes mellitus | Medical University of Vienna | Completed | Met primary |
| Phase 3 | NCT02194595 | Sep 2014 → Dec 2021 | type 2 diabetes mellitus | Mount Sinai Hospital, Canada | Completed | No outcome recorded |
| Phase 3 | NCT02227212 | Aug → Nov 2014 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02192424 | Jul 2014 → Aug 2020 | type 2 diabetes mellitus | Mount Sinai Hospital, Canada | Completed | No outcome recorded |
| Phase 3 | NCT02132637 | May 2014 → Jul 2015 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02030600 | Jan 2014 → Dec 2015 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT02034513 | Jan 2014 → Jan 2016 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01849289 | Jun 2013 → May 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01755468 | Apr 2013 → Oct 2017 | type 2 diabetes mellitus | Mount Sinai Hospital, Canada | Completed | No outcome recorded |
| Phase 3 | NCT01689142 | Sep 2012 → Nov 2013 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01689129 | Sep 2012 → Oct 2013 | type 1 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01676220 | Aug 2012 → Sep 2013 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01570751 | Apr 2012 → Jan 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01461616 | Feb → Nov 2012 | type 1 diabetes mellitus | University of Aarhus | Completed | No outcome recorded |
| Phase 3 | NCT01499082 | Dec 2011 → Jan 2013 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01499095 | Dec 2011 → Apr 2013 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01136746 | Mar → Nov 2011 | hyperglycemia | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01223131 | Feb 2011 → Mar 2014 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01272193 | Jan → Sep 2011 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01135992 | Jun → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01045707 | Jan → Oct 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01006291 | Nov 2009 → Sep 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00993473 | Oct 2009 → Mar 2011 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00851903 | Jun 2009 → Sep 2011 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00943709 | May 2009 → Mar 2010 | hyperglycemia, leukemia | University of Medicine and Dentistry of New Jersey | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00437112 | Feb 2007 → May 2008 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00355849 | Aug 2006 → Jun 2008 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00331851 | May 2006 → Apr 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00271284 | Oct 2005 → Sep 2008 | type 1 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00272064 | Oct 2005 → May 2008 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00687466 | Aug 2005 → Oct 2009 | cystic fibrosis, glucose intolerance | Fondazione per la ricerca sulla Fibrosi Cistica | Unknown | No outcome recorded |
| Phase 3 | NCT00135941 | Aug 2005 → Sep 2007 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00151697 | May 2005 → ? | type 2 diabetes mellitus | Rijnstate Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00106366 | Mar → Dec 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00097877 | Jan 2005 → Nov 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00174668 | Nov 2004 → Nov 2007 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00095082 | Sep 2004 → Dec 2005 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00097084 | Sep 2004 → Dec 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00099619 | Sep 2004 → Aug 2005 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00500240 | Apr 2004 → Apr 2012 | acute leukemia, lymphoma | M.D. Anderson Cancer Center | Terminated | Missed primary |
| Phase 3 | NCT00069784 | Aug 2003 → Dec 2011 | type 2 diabetes mellitus | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00283751 | Mar 2003 → Nov 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00046501 | Nov 2002 → Feb 2005 | diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00272090 | Nov 2002 → Dec 2005 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00598793 | Nov 2002 → Mar 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00563225 | Oct 2002 → Apr 2004 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00312104 | Apr 2002 → Mar 2003 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00783744 | Dec 2001 → Aug 2003 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00046462 | Nov 2001 → Nov 2004 | type 2 diabetes mellitus | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00537251 | Nov 2001 → Feb 2004 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01336751 | Jul 2001 → Dec 2002 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00653341 | Jan 2000 → Oct 2001 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4136 trials · 16 met primary · 15 missed | ||||||
| Phase 4 | NCT07117240 | Jul 2025 → Feb 2028 expected | diabetes mellitus, hyperglycemia | Medical University of Warsaw | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06999551 | Jul → Dec 2025 overdue | type 2 diabetes mellitus | Les Laboratoires des Médicaments Stériles | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05614089 | Mar 2023 → Aug 2024 | type 1 diabetes mellitus | Jing Luo | Completed | Missed primary |
| Phase 4 | NCT05552859 | Dec 2022 → Jul 2023 | impaired renal function disease, type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06717191 | Jun 2022 → Jun 2024 | type 1 diabetes mellitus | Life for a Child Program, Diabetes Australia | Completed | No outcome recorded |
| Phase 4 | NCT06674135 | Jun 2022 → Aug 2023 | type 1 diabetes mellitus | Life for a Child Program, Diabetes Australia | Completed | No outcome recorded |
| Phase 4 | NCT06624943 | Mar 2022 → May 2023 | type 1 diabetes mellitus | Life for a Child Program, Diabetes Australia | Completed | No outcome recorded |
| Phase 4 | NCT04323462 | Oct 2021 → Nov 2022 | ulcer of lower limbs | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT04864977 | Aug 2021 → Jun 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04980027 | Jun 2021 → Dec 2022 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Show all 136 trials opens the full record — a long page | ||||||
| Phase not applicable23 trials | ||||||
| — | NCT07171684 | Nov 2025 → Oct 2026 expected | gestational diabetes | Rutgers, The State University of New Jersey | Recruiting | No outcome recorded |
| — | NCT06419777 | Sep 2024 → May 2026 overdue | gestational diabetes | Thomas Jefferson University | Recruiting | No outcome recorded |
| — | NCT04553380 | Dec 2020 → Dec 2021 | type 2 diabetes mellitus | Shenzhen Second People's Hospital | Unknown | No outcome recorded |
| — | NCT03829891 | Aug 2018 → Dec 2019 | type 2 diabetes mellitus | Xijing Hospital | Completed | No outcome recorded |
| — | NCT03180281 | Jul 2017 → Jan 2020 | type 2 diabetes mellitus | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| — | NCT02694289 | Nov 2016 → Sep 2018 | type 2 diabetes mellitus | Maya Guglin | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT02930044 | Oct 2016 → Nov 2021 | diabetic ketoacidosis | University of Maryland, Baltimore | Completed | No outcome recorded |
| — | NCT02548494 | Nov 2015 → Feb 2019 | diabetic ketoacidosis, type 1 diabetes mellitus | Chattanooga-Hamilton County Hospital Authority | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02144441 | Jun → Oct 2014 | diabetes mellitus | University of Pennsylvania | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT02204839 | Jan 2014 → Jan 2015 | type 1 diabetes mellitus | Northumbria University | Completed | No outcome recorded |
| — | NCT01974544 | May 2013 → Dec 2015 | type 2 diabetes mellitus | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| — | NCT02006342 | Nov 2012 → Apr 2013 | diabetic ketoacidosis | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| — | NCT01424046 | May 2011 → Jun 2014 | type 1 diabetes mellitus | University of Pittsburgh | Completed | No outcome recorded |
| — | NCT01335763 | Apr 2011 → Oct 2012 | type 2 diabetes mellitus | University of Alberta | Completed | No outcome recorded |
| — | NCT01276912 | Jan 2011 → Oct 2013 | prediabetes syndrome | Beijing Tongren Hospital | Unknown | No outcome recorded |
| — | NCT01257087 | Dec 2010 → Feb 2016 | obesity disorder, type 2 diabetes mellitus | Imperial College London | Completed | No outcome recorded |
| — | NCT00978263 | Feb 2009 → Dec 2011 | diabetes mellitus | Chongqing Medical University | Completed | No outcome recorded |
| — | NCT00469833 | Apr 2008 → Dec 2011 | hyperglycemia, type 2 diabetes mellitus | US Department of Veterans Affairs | Completed | No outcome recorded |
| — | NCT00659165 | Apr 2008 → Dec 2010 | diabetes mellitus | University of New Mexico | Completed | No outcome recorded |
| — | NCT00457093 | Oct 2006 → May 2007 | type 2 diabetes mellitus | Diabetes Care Center | Completed | No outcome recorded |
| — | NCT00564018 | Sep 2006 → Feb 2009 | type 1 diabetes mellitus | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| — | NCT00464854 | Jul 2005 → Sep 2006 | diabetes mellitus | Assaf-Harofeh Medical Center | Terminated | No outcome recorded |
| — | NCT00179127 | Aug 2004 → Jul 2009 | diabetic ketoacidosis | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Comparator or background therapy318 trials | ||||||
| Phase 0 | NCT03400501 Comparator | Oct 2017 → Jun 2021 | type 1 diabetes mellitus | Yale University | Completed | No outcome recorded |
| Phase 0 | NCT02012465 Background | Sep 2013 → May 2015 | hyperglycemia, lymphoma, type 2 diabetes mellitus | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT05596747 Comparator | Nov 2022 → Oct 2023 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05373186 Comparator | May → Dec 2022 | — | Adocia | Completed | No outcome recorded |
| Phase 1 | NCT05373199 Comparator | May → Oct 2022 | type 1 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Show all 318 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 117
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals’ Insulin Glargine Approved in South Africa ganlee.com ↗
Gan & Lee Pharmaceuticals (stock code: 603087.SH) recently received registration approval from the South African Health Products Regulatory Authority (SAHPRA) for its independently developed insulin glargine injection in both cartridge and prefilled pen presentations. |
| 2026-09-30 | Eli Lilly and Company | Results Lilly's oral GLP-1, Foundayo (orforglipron), demonstrated cardiovascular safety alongside sustained A1C reduction and weight loss in its largest and longest type 2 diabetes study lilly.com ↗
In ACHIEVE-4, participants taking Foundayo experienced a 16% lower risk of MACE-4 and a 23% lower risk of MACE-3, meeting the primary objective for non-inferiority compared to insulin glargine |
| 2026-08-25 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Insulin Glargine Prefilled Pen Receives Marketing Approval in Thailand ganlee.com ↗
Gan & Lee Pharmaceuticals. (stock code: 603087.SH) has recently obtained marketing approval from the Thai Food and Drug Administration (Thai FDA) for its independently developed insulin glargine prefilled pen, which is indicated for the treatment of diabetes. |
| 2026-07-16 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Secures Dual Approvals for Insulin Glargine Injection and Prefilled Pen in Honduras ganlee.com ↗
July 9, 2026, Gan & Lee Pharmaceuticals ("Gan & Lee"; stock code: 603087.SH) announced that its independently developed insulin glargine prefilled pen was granted a drug registration certificate by the Agencia de Regulación Sanitaria (ARSA). |
| 2026-07-02 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Insulin Glargine Pre-filled Pen Approved in the UAE ganlee.com ↗
Gan & Lee Pharmaceuticals (Stock Code: 603087.SH) announced that its insulin glargine prefilled pen (available in 1-pen and 5-pen pack sizes) has obtained marketing approval from the Emirates Drug Establishment (EDE)of the United Arab Emirates (UAE). |
| 2026-06-30 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Insulin Glargine Injection Approved in Honduras ganlee.com ↗
Gan & Lee Pharmaceuticals (stock code: 603087.SH) announced that its independently developed insulin glargine injection has officially obtained a drug registration certificate issued by Agencia de Regulación Sanitaria (ARSA). |
| 2026-06-05 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee’s Once-Weekly Basal insulin GZR4 Injection Met the Primary Endpoint in the Pivotal Phase 3 SUPER-3 Trial and Demonstrated Superior HbA1c Reduction Versus Insulin Glargine U100 ganlee.com ↗
The study results showed that after 26 weeks of treatment in combination with insulin aspart, once-weekly GZR4 injection demonstrated statistically significantly superiority in HbA1c reduction compared with once-daily insulin glargine U100. |
| 2026-04-16 | Eli Lilly and Company | Results ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health lilly.com ↗
In the trial, Foundayo met the primary endpoint by demonstrating a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest pain, compared to insulin glargine. |
| 2026-03-30 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Once-Weekly Basal Insulin GZR4 Injection Meets Primary Endpoints in Two Pivotal Phase 3 Clinical Trials: SUPER-1 and SUPER-2 ganlee.com ↗
After 26 weeks of treatment, once-weekly GZR4 demonstrated statistically significant superior efficacy in reducing glycated hemoglobin A1c (HbA1c) * compared with once-daily insulin glargine U100 (Lantus ® ) and once-daily insulin degludec (Tresiba ® ). |
| 2026-02-03 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Insulin Glargine Injection Pre-filled Pen Receives Marketing Authorization in Algeria ganlee.com ↗
The successful registration approval of the insulin glargine injection (pre-filled pen),further enhances the company's commercialized insulin product portfolio in Algeria. |
| 2026-01-21 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Receives Approval for Insulin Glargine in Ethiopia, Strengthening Presence in the African Market ganlee.com ↗
The regulatory approval in Ethiopia stands as yet another endorsement of Gan & Lee's product portfolio by international regulatory authorities. |
| 2026-01-14 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Ondibta® Receives EU Marketing Authorization, Becoming the First China-Developed Third-Generation Insulin to be approved for the European Market ganlee.com ↗
This approval marks the official entry of Gan & Lee's insulin glargine injection into the European market, with commercial launch planned across the European Union (EU), Iceland, Liechtenstein, and Norway. |
| 2025-11-13 | Gan and Lee Pharmaceuticals, USA | Regulatory A Breakthrough for China-Developed Insulin Glargine in the EU market： Gan & Lee’s Ondibta® Receives Positive CHMP Opinion, Paving the Way of the First China-Developed Insulin Glargine for patients in Europe ganlee.com ↗ |
| 2025-10-17 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals’ Basalin™ (Insulin Glargine Injection) Receives Approval in Egypt ganlee.com ↗
Gan & Lee Pharmaceuticals. (hereinafter referred to as Gan & Lee, stock code: 603087.SH) announced that its independently developed and manufactured insulin glargine injection, Basalin ™ , has officially received marketing approval from the Egyptian Drug Authority (EDA). |
| 2025-09-30 | Jiangsu HengRui Medicine Co., Ltd. | Results 恒瑞医药新型长效胰岛素类似物舒地胰岛素（INS068）两项降糖III期研究亮相EASD简短口头报告 hengrui.com ↗
本研究达到预设的主要终点，治疗26周后，INS068组的HbA1c相对基线变化非劣于IGlar组。 |
| 2025-08-28 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals' Preclinical Results of Novel Premixed Insulin GZR101 Published in Naunyn-Schmiedeberg's Archives of Pharmacology ganlee.com ↗
The results demonstrate that GZR101 exhibits favorable pharmacokinetic (PK) and pharmacodynamic (PD) characteristics. |
| 2025-06-22 | Eli Lilly and Company | Results Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials lilly.com ↗
In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand. |
| 2025-05-29 | Gan and Lee Pharmaceuticals, USA | Results Multinational Diabetes Academic Conference 2025 Opens in Beijing, Gathering Global Experts to Explore New Trends in Prevention and Treatment ganlee.com ↗
The study confirmed that EZELIN ® exhibits bioequivalence to the reference product Lantus ® in terms of glycemic efficacy, safety, and pharmacokinetic profile for treating Type 2 Diabetes. |
| 2025-04-07 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals' Insulin Glargine Receives DRAP Approval in Pakistan ganlee.com ↗
Gan & Lee now stands as the only biopharmaceutical company in Pakistan to secure first-biosimilar approval for insulin glargine in two dosage forms, thereby reinforcing its position in the country’s diabetes treatment sector. |
| 2025-02-14 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Received Approval of Insulin Glargine Products in Malaysia ganlee.com ↗
Gan & Lee Pharmaceuticals, a leading global biopharmaceutical company (hereinafter referred to as Gan & Lee, stock code: 603087.SH)，announced that its insulin glargine injection and insulin glargine prefilled pen products, developed in collaboration with a major Malaysian pharmaceutical company in Malaysia, have received registration approval from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. |
| 2024-12-17 | Eli Lilly and Company | Regulatory Lilly and EVA Pharma announce regulatory approval and release of locally manufactured insulin in Egypt lilly.com ↗
The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). |
| 2024-09-05 | Eli Lilly and Company | Results In a first-of-its-kind fixed dose study, once weekly insulin efsitora alfa leads to A1C reduction similar to daily insulin lilly.com ↗
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 52. |
| 2024-08-22 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee’s Insulin Glargine U300 Clinical Research Findings Published in Frontiers in Endocrinology ganlee.com ↗
The study results indicate that Gan & Lee’s Insulin Glargine U300 is bioequivalent to the reference product Toujeo ® in terms of safety, PK, and PD in healthy subjects. |
| 2024-05-31 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals' Insulin Glargine Injection Prefilled Pen Approved in Mexico ganlee.com ↗
Gan & Lee Pharmaceuticals (referred to as Gan & Lee, stock code: 603087. SH), a global biopharmaceutical company, has recently received registration approval for its insulin glargine injection prefilled pen from Mexico's Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). |
| 2024-05-16 | Eli Lilly and Company | Results With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin lilly.com ↗
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 26. |
| 2024-04-03 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals' Overseas Clinical Research on Insulin Glargine was Published in Journal Diabetes, Obesity and Metabolism ganlee.com ↗
Recently, Gan & Lee Pharmaceuticals published the results of its Phase III clinical trial (GLITTER 2 Study) of insulin glargine (brand name Basalin ®️ ) in the prestigious international academic journal Diabetes, Obesity and Metabolism. |
| 2024-01-08 | Novo Nordisk A/S | Results COMBINE 3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily basal-bolus treatment (insulin glargine U100 and insulin aspart) in people with type 2 diabetes novonordisk.com ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart. |
| 2023-10-23 | Adocia | Results ADOCIA’s Partner Tonghua Dongbao Announces Positive Results of Three Clinical Trials on BioChaperone® Combo adocia.com ↗ |
| 2023-10-16 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals' Overseas Clinical Research on Three Insulin Products was Published in Journal Diabetes, Obesity and Metabolism ganlee.com ↗
Recently, Gan & Lee Pharmaceuticals published the results of the Phase I clinical trial of three insulin products – Basalin ®️ (insulin glargine), Prandilin ®️ (insulin lispro), and Rapilin ®️ (insulin aspart) - in the peer-reviewed journal Diabetes, Obesity and Metabolism. |
| 2023-10-11 | Gan and Lee Pharmaceuticals, USA | Results EASD 2023丨Diabetes Treatment - Basalin®️ Adds Two New Overseas Phase III Clinical Evidence ganlee.com ↗
The results of the studies showed that Basalin ®️ is bioequivalent to Lantus ®️ in terms of immunogenicity, efficacy, and safety. |
| 2023-08-21 | Gan and Lee Pharmaceuticals, USA | Regulatory The Scientific Evaluation from EMA on Marketing Authorisation Application of Gan & Lee Insulin Glargine biosimilar starts upon the Positive Validation Letter ganlee.com ↗
The EMA has accepted the MAA for review, and with this acceptance, the formal review process will begin. |
| 2023-05-10 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Insulin Glargine Pre-filled Pen in India ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce its 3mL insulin glargine pre-filled pen which is in cooperation with local Indian customers has been approved for marketing in India. |
| 2023-04-24 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Insulin Glargine Injection in Bolivia ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce its insulin glargine injection has been approved by the Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED of Bolivia for the treatment of diabetes. |
| 2023-04-04 | Lannett Company, Inc. | Results LANNETT SHARES UPDATE investorroom.com ↗
The pivotal clinical trial of biosimilar insulin glargine demonstrated positive results, in line with prior expectations. |
| 2023-02-23 | Gan and Lee Pharmaceuticals, USA | Regulatory The First Chinese Insulin Biologics License Application Submission was Officially Accepted by the US FDA upon the Filing Notification Letter ganlee.com ↗
It is an exciting milestone that the BLA submission of Gan & Lee Insulin Glargine Injection was accepted for filing by the US FDA. |
| 2022-12-26 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Two Local-filling Insulin Preparations in Indonesia ganlee.com ↗
The two locally-produced products have been approved by the Indonesia Ministry of Public Health for the treatment of diabetes. |
| 2022-12-08 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Insulin Glargine in Pakistan ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce its insulin glargine(prefilled pen) has been approved by the Regulatory Authority of Pakistan for the treatment of diabetes. |
| 2022-10-18 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Insulin Glargine in Thailand ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce its insulin glargine product has been approved by the TFDA for the treatment of diabetes. |
| 2022-10-03 | Novo Nordisk A/S | Results Once-weekly insulin icodec demonstrates superior reduction in HbA1c in combination with a dosing guide app versus once-daily basal insulin in people with type 2 diabetes in ONWARDS 5 phase 3a trial novonordisk.com ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared with once-daily basal insulin analogues. |
| 2022-07-29 | Novo Nordisk A/S | Results Novo Nordisk achieves primary objectives of ONWARDS 3 and 4 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin degludec in ONWARDS 3 novonordisk.com ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared with insulin glargine. |
| 2022-06-03 | Novo Nordisk A/S | Results Novo Nordisk achieves primary objectives of ONWARDS 1 and 6 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin glargine U100 in ONWARDS 1 novonordisk.com ↗
From an overall baseline HbA1c of 8.5% once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of -1.55% compared to -1.35% for insulin glargine (estimated treatment difference: -0.19%). |
| 2022-04-11 | Adocia | Regulatory ADOCIA Announces Start of 3 Clinical Studies for BioChaperone® Combo with Partner Tonghua Dongbao adocia.com ↗ |
| 2022-01-21 | Lannett Company, Inc. | Regulatory LANNETT ANNOUNCES FDA COMPLETES REVIEW OF INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR BIOSIMILAR INSULIN GLARGINE investorroom.com ↗ |
| 2021-12-20 | Lannett Company, Inc. | Regulatory Lannett Announces Submission of Investigational New Drug (IND) Application For Biosimilar Insulin Glargine investorroom.com ↗
Lannett Company, Inc. (NYSE: LCI) today announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the pivotal clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC). |
| 2021-10-19 | Eli Lilly and Company | Results Tirzepatide results published in The Lancet show superior A1C and body weight reductions compared to insulin glargine in adults with type 2 diabetes with increased cardiovascular risk lilly.com ↗ |
| 2021-10-14 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Concludes Phase 3 Studies of Gan & Lee Insulin Glargine (GL-GLA) ganlee.com ↗
Both studies concluded there was equivalent TI immunogenicity. |
| 2021-09-09 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals to present data at the 57th Annual European Association for the Study of Diabetes Meeting ganlee.com ↗
Proposed biosimilar insulin glargine (GL-GLA) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin glargine. |
| 2021-07-28 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Inc. and Biocon Biologics Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn) injection for the Treatment of Diabetes viatris.com ↗
Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee® (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway. |
| 2021-07-02 | Gan and Lee Pharmaceuticals, USA | Results New Data on Phase 1 Proposed Biosimilar Gan & Lee Insulins Aspart (GL-ASP), Lispro (GL-LIS), and Glargine (GL-GLA) Presented at the American Diabetes Association’s 81st Scientific Sessions ganlee.com ↗
These data demonstrate pharmacokinetic and pharmacodynamic bioequivalence between each of the proposed biosimilar Gan & Lee insulins and their respective reference compounds. |
| 2021-06-28 | Sanofi | Results Media Update: New Soliqua®* data shows improved blood sugar control without weight gain versus premixed insulin sanofi.com ↗
The study met both primary endpoints with Soliqua demonstrating noninferiority of blood sugar (HbA 1c ) reduction and superiority on body weight change from baseline compared to premixed insulin. |
| 2021-05-20 | Eli Lilly and Company | Results Lilly's tirzepatide achieves all primary and key secondary study outcomes against insulin glargine in adults with type 2 diabetes and increased cardiovascular risk in SURPASS-4 trial lilly.com ↗
All three doses of tirzepatide (5 mg, 10 mg and 15 mg) led to superior A1C and body weight reductions compared to insulin glargine for both estimandsii. |
| 2019-12-04 | Lannett Company, Inc. | Results Lannett Announces Positive Results From Human Clinical Trial Of Biosimilar Insulin Glargine Versus US Lantus® investorroom.com ↗
Lannett Company, Inc. (NYSE: LCI) today announced positive results from the first human study evaluating insulin glargine that Lannett is developing with its strategic alliance partners within the HEC Group of companies (HEC). |
| 2019-02-12 | Adocia | Results Adocia to Present New Clinical Data on BioChaperone® Technology at ATTD 2019 adocia.com ↗
BioChaperone Combo, A Co-Formulation Of Lispro And Glargine, Improves Postprandial Glucose Control Compared To Lispromix25 Or Lispro And Glargine Injections In Type 2 Diabetes Subjects |
| 2018-06-23 | Merck Sharp & Dohme LLC | Results Merck Presents New Data from the Comparative Trials with Sitagliptin (CompoSIT) Clinical Trial Program with JANUVIA® (sitagliptin) merck.com ↗
In the CompoSIT-I study, initiation of insulin therapy while continuing treatment with JANUVIA resulted in greater blood glucose reductions and more patients reaching A1C goal compared to those who discontinued JANUVIA. |
| 2017-10-30 | Mannkind Corporation | Results Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients mannkindcorp.com ↗
A1C was reduced by -0.66% and -0.72% in the TI+G and BPA 70/30 groups, respectively, and the proportion of subjects achieving A1C <7.0% were comparable between treatments (22% vs 27%). |
| 2017-10-30 | Mannkind Corporation | Results American Diabetes Association/The Lancet Symposium Will Highlight Study Showing AFREZZA(R) Provides Comparable Glycemic Control with Less Weight Gain and Hypoglycemia than Standard of Care mannkindcorp.com ↗
Our findings show that mealtime AFREZZA, in combination with once-daily injected glargine, provides equivalent glucose control with fewer injections, less hypoglycemia and less weight gain than does twice-a-day, premixed insulin. |
| 2017-10-30 | Mannkind Corporation | Results AFREZZA Demonstrates Non-Inferiority Compared to Standard Therapy in Controlling Blood Sugar Levels in Type 1 Diabetes Patients mannkindcorp.com ↗
In addition, patients treated with AFREZZA had significantly lower rates of total and mild/moderate hypoglycemia (6.2 versus 8.2 events per subject month [p=0.0345] and 6.0 versus 8.0 events per subject month [p=0.0269], respectively). |
| 2017-09-05 | Adocia | Results Adocia Announces Two Data Presentations at the 53rd Annual Meeting of the European Association for the Study of Diabetes adocia.com ↗
The present poster demonstrates that the proprietary BioChaperone® technology enables solubilization of insulin glargine at neutral pH, which in turns allows its combination with multiple GLP -1 receptor agonists in solution. |
| 2017-07-20 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. FDA Grants Tentative Approval for LUSDUNA™ Nexvue™ (insulin glargine injection), a Follow-On Biologic Basal Insulin merck.com ↗
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection) 100 units/mL, a follow-on biologic 1 basal insulin in a pre-filled dosing device. |
| 2017-05-27 | Novo Nordisk A/S | Results Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba® label novonordisk.com ↗
In the DEVOTE trial, the primary endpoint was achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba® compared to insulin glargine U100. |
| 2016-11-29 | Novo Nordisk A/S | Results Novo Nordisk A/S: Tresiba® demonstrates a safe cardiovascular profile and reduces the risk of severe hypoglycaemia compared to insulin glargine U100 in the DEVOTE trial novonordisk.com ↗
The trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba® compared to insulin glargine U100. |
| 2016-11-10 | Novo Nordisk A/S | Results Novo Nordisk submits application in the EU for including data from the two SWITCH trials in Tresiba® label novonordisk.com ↗
During the study's maintenance period, people treated with Tresiba® on average had 11% fewer episodes of overall symptomatic blood glucose confirmed hypoglycaemia, 36% fewer episodes of nocturnal blood glucose confirmed symptomatic hypoglycaemia and 35% fewer episodes of severe hypoglycaemia. |
| 2016-08-05 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine merck.com ↗ |
| 2016-06-13 | Merck Sharp & Dohme LLC | Results Merck’s Investigational Insulin Glargine, MK-1293, Met Primary Endpoint in Two Phase 3 Studies, Showing Non-Inferiority to Lantus® merck.com ↗
Furthermore, in both studies, MK-1293 met its pre-specified secondary efficacy endpoints of statistical A1C equivalence to Lantus, a measure used to show that an investigational treatment is similar, within an acceptable range, to a current therapy. |
| 2016-06-12 | Eli Lilly and Company | Results New Data Show Lilly's Once-Weekly Trulicity® (dulaglutide) in Combination with Insulin Glargine Improves Glycemic Control in People with Type 2 Diabetes lilly.com ↗
After 28 weeks of treatment, Trulicity 1.5 mg plus insulin glargine significantly reduced A1C from baseline (1.44 percent) compared to placebo with insulin glargine (0.67 percent). |
| 2016-06-06 | Adocia | Results Adocia to Present Data Validating the Potential of BioChaperone® Technology at the American Diabetes Association® 76th Scientific Sessions adocia.com ↗
will present data showing improvement of postprandial glycemia in patients with t ype 1 diabetes using BioChaperone® Combo vs. Humalog® Mix75/25TM. |
| 2016-02-23 | Novo Nordisk A/S | Results Tresiba® viser signifikant lavere forekomst af hypoglykæmi end insulin glargin U100 i blindet fase 3b-studie i mennesker med type 1-diabetes novonordisk.com ↗
Studiet opfyldte sit primære mål, idet det viste ikke-inferiøritet med hensyn til forekomsten af alvorlig eller symptomatisk hypoglykæmi bekræftet ved blodsukkermåling for Tresiba® sammenlignet med insulin glargin. |
| 2016-02-23 | Novo Nordisk A/S | Results Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine U100 in blinded phase 3b trial in people with type 1 diabetes novonordisk.com ↗
The observed rate was 2,201 events per 100 patient years exposed to Tresiba® and 2,463 events per 100 patient years exposed to insulin glargine during the maintenance period, corresponding to a statistically significant reduction of 11%. |
| 2016-01-29 | Novo Nordisk A/S | Results Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine in blinded phase 3b trial in people with type 2 diabetes novonordisk.com ↗
This reduction was statistically significant, and the trial thus met its primary endpoint by demonstrating a reduction of 30% when people were treated with Tresiba® compared to insulin glargine. |
| 2015-12-16 | Eli Lilly and Company | Regulatory FDA Approves Basaglar® (insulin glargine injection), a Long-Acting Insulin Treatment lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Basaglar® (insulin glargine injection) 100 units/mL. |
| 2015-11-18 | Novo Nordisk A/S | Results Highlights to be presented at Novo Nordisk's Capital Markets Day 2015 novonordisk.com ↗
The mean daily insulin glargine dose was 29 units. |
| 2015-09-15 | AstraZeneca | Results AstraZeneca announces new tolerability, long-term efficacy and real-world adherence data for exenatide once weekly in patients with type 2 diabetes astrazeneca.com ↗
d 16.5% IG-treated patients achieved goal of HbA1c ≤ 6.5%, while 28.9% and 7.0% of patients, respectively, achieved the composite goal of HbA1c < 7% without hypoglycaemia or weight gain. |
| 2015-06-08 | Eli Lilly and Company | Results New Data Show Superiority of Lilly's Once-Weekly Trulicity™ (dulaglutide) to Lantus® (insulin glargine) in Patients with Type 2 Diabetes lilly.com ↗
After 26 weeks, both doses of Trulicity were superior to Lantus in A1C reduction, and significantly more patients reached the recommended A1C target of less than 7 percent. |
| 2015-06-06 | Eli Lilly and Company | Results Lilly's Basal Insulin Peglispro Shows Superiority to Insulin Glargine in Reducing HbA1c in People with Type 2 Diabetes lilly.com ↗
Eli Lilly and Company's (NYSE: LLY) basal insulin peglispro (BIL) consistently demonstrated superior hemoglobin A1c (HbA1c) reduction in people with type 2 diabetes compared to insulin glargine across three Phase III trials. |
| 2015-06-06 | Eli Lilly and Company | Results Basal Insulin Peglispro Studies Demonstrate Superiority to Insulin Glargine Across Multiple Measures in People with Type 1 Diabetes lilly.com ↗
In IMAGINE-1 and IMAGINE-3, BIL demonstrated superiority in HbA1c compared to insulin glargine. |
| 2015-05-27 | Eli Lilly and Company | Results Lilly to Present New Clinical Data at 75th American Diabetes Association® Scientific Sessions lilly.com ↗
Basal Insulin Peglispro (BIL) is Superior to Insulin Glargine (GL) in Reducing HbA1c at 52 Weeks in Insulin-Naïve T2D Patients (Pts) Treated with Oral Antihyperglycemic Medications (OAMs): IMAGINE 2 |
| 2014-09-10 | Eli Lilly and Company | Regulatory European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe lilly.com ↗
The European Commission (EC) granted marketing authorisation for Eli Lilly and Company and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. |
| 2014-09-04 | Eli Lilly and Company | Results Lilly's Basal Insulin Peglispro Demonstrated HbA1c Superiority against Lantus® in Phase III Trials in Patients with Type 1 Diabetes lilly.com ↗
The primary efficacy endpoint of non-inferior HbA1c at the primary study endpoint compared with insulin glargine was met in both the IMAGINE-1 and IMAGINE-3 trials, and superiority was demonstrated. |
| 2014-08-18 | Eli Lilly and Company | Regulatory FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar™ (insulin glargine injection) lilly.com ↗
The U.S. Food and Drug Administration (FDA) today granted tentative approval for Basaglar™ (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. |
| 2014-06-27 | Eli Lilly and Company | Regulatory CHMP Recommends Lilly and Boehringer Ingelheim's Investigational New Insulin Glargine Product for Approval in the European Union lilly.com ↗
The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes. |
| 2014-06-16 | Eli Lilly and Company | Results Lilly Announces Detailed Results from Two Phase III Studies Testing Both Doses of Dulaglutide vs. Insulin Glargine lilly.com ↗
SAN FRANCISCO, June 16, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today released detailed results from two AWARD trials that showed treatment with once-weekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin glargine, with a lower risk for hypoglycemia. |
| 2014-06-14 | Merck Sharp & Dohme LLC | Results New Post-Hoc Analysis Shows Patients with Type 2 Diabetes Undergoing Intensification of Insulin Therapy Experienced Less Nighttime Hypoglycemia While Being Treated with JANUVIA® (sitagliptin) Compared to Placebo merck.com ↗ |
| 2014-06-14 | Eli Lilly and Company | Results Studies Show Investigational New Insulin Glargine Product from Lilly and Boehringer Ingelheim Similar Safety and Efficacy Profile to Lantus® lilly.com ↗
For the first time today, Eli Lilly and Company (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals Inc. presented data showing that LY2963016, the alliance's investigational new insulin glargine product, has a similar safety and efficacy profile to currently marketed insulin glargine (Lantus®). |
| 2014-06-14 | Eli Lilly and Company | Results Lilly's Basal Insulin Peglispro Shows Novel Mechanism of Action lilly.com ↗
When BIL and insulin glargine were each administered to achieve complete suppression of glucose production, which principally comes from the liver, BIL showed less activity in peripheral tissues, such as muscle and fat, than insulin glargine. |
| 2014-06-09 | Eli Lilly and Company | Results Diabetes: Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 43 Presentations at the 74th American Diabetes Association Scientific Sessions® lilly.com ↗
Similar Efficacy and Safety with LY2963016 Insulin Glargine Compared with Lantus® Insulin Glargine in Patients with T2D: the ELEMENT 2 Study |
| 2014-05-12 | Eli Lilly and Company | Results Lilly's Basal Insulin Peglispro Shows Superiority in HbA1c Reduction Compared to Insulin Glargine in Three Phase III Trials in Patients with Type 2 Diabetes lilly.com ↗
Having met the primary endpoints, superiority for HbA1c lowering was examined and, in all three trials, BIL showed a statistically superior reduction in HbA1c compared with insulin glargine. |
| 2014-03-17 | Adocia | Results Adocia: confirmation of positive clinical results Combo adocia.com ↗ |
| 2013-12-20 | Eli Lilly and Company | Regulatory Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for LY2963016, an investigational basal (long-acting) insulin. |
| 2013-09-17 | Eli Lilly and Company | Results Lilly to Present Data Across its Diabetes Portfolio at the 49th European Association for the Study of Diabetes Annual Meeting lilly.com ↗
LY2605541 exhibits a flatter glucodynamic profile than insulin glargine at steady state in subjects with type 1 diabetes |
| 2013-07-08 | Eli Lilly and Company | Regulatory Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin glargine biosimilar product lilly.com ↗
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the companies' marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency (EMA). |
| 2013-06-24 | GlaxoSmithKline | Results GSK announces data from five Phase III studies of albiglutide, an investigational once-weekly treatment for type 2 diabetes gsk.com ↗
Both groups achieved a similar reduction in HbA1c (-0.7% and -0.8% in the albiglutide and insulin glargine groups). |
| 2013-06-22 | Eli Lilly and Company | Results Follow-up Phase II Data Analysis Adds to Body of Evidence for Investigational Novel Basal Insulin, LY2605541 lilly.com ↗
LY2605541-treated patients had a statistically higher overall hypoglycemia rate (blood glucose less than or equal to 70 mg/dL) compared to insulin glargine (9.2 vs. 8.1 events/30 days) but a statistically lower rate of nocturnal hypoglycemia (0.9 vs. 1.2 events/30 days). |
| 2013-04-16 | Eli Lilly and Company | Results Lilly Announces Positive Results of Phase III Trials of Dulaglutide in Type 2 Diabetes lilly.com ↗
The dulaglutide 1.5 mg dose demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine at 52 weeks in patients with type 2 diabetes on metformin and glimeperide (AWARD-2). |
| 2012-10-02 | Eli Lilly and Company | Results Lilly and Boehringer Ingelheim Present Health Outcomes Data for Investigational Novel Basal Insulin Analogue lilly.com ↗
In addition to the reduction in nocturnal hypoglycaemia in LY2605541-treated patients, results showed the treatments had similar overall rates of hypoglycaemia (p=0.08, not statistically significant). |
| 2012-09-24 | Eli Lilly and Company | Results Data from Boehringer Ingelheim and Lilly showcase strength of Diabetes Alliance at EASD Annual Meeting lilly.com ↗
Novel long-acting basal insulin analog LY2605541 significantly reduces nocturnal hypoglycemia and fear of hypoglycemia compared to insulin glargine in patients with type 2 diabetes mellitus |
| 2012-06-11 | Eli Lilly and Company | Results Lilly and Boehringer Ingelheim Present Data at the 72nd American Diabetes Association Scientific Sessions® from Phase II Studies Comparing Investigational Novel Basal Insulin to Insulin Glargine lilly.com ↗
Results of the type 1 diabetes study showed that LY2605541 was associated with greater improvements of glycemic control (lowering blood sugar levels) than insulin glargine. |
| 2011-11-07 | Novo Nordisk A/S | Results Novo Nordisk A/S: DegludecPlus provides superior glycaemic control compared to insulin glargine in a phase 3a trial in Japanese people with type 2 diabetes novonordisk.com ↗ |
| 2011-09-13 | Alkermes, Inc. | Results Analyses Find Type 2 Diabetes Patients Treated with BYDUREON(TM) Experienced Reduction in Cardiovascular Risk Factors: Results Presented at EASD 2011 alkermes.com ↗
Met a composite endpoint of A1C <7 percent plus target systolic blood pressure (<130 mmHg) and LDL cholesterol (<100 mg/dL) (15.7 percent vs. 7.9 percent with Lantus) |
| 2011-09-12 | Eli Lilly and Company | Results Analyses Find Type 2 Diabetes Patients Treated with BYDUREON™ Experienced Reduction in Cardiovascular Risk Factors: Results Presented at EASD 2011 lilly.com ↗
Demonstrated statistically significant reduction in body weight (vs. Lantus; treatment difference: 9.8 pounds). |
| 2011-06-24 | Eli Lilly and Company | Results Studies Show Effect of BYDUREON™ on A1C and Weight for Up to Three Years lilly.com ↗
Separately, results from the DURATION-3 study showed that at 84 weeks, patients treated with BYDUREON experienced significantly greater A1C reduction from baseline, sustained weight loss and a lower risk of hypoglycemia than patients treated with Lantus® (insulin glargine). |
| 2011-06-24 | Alkermes, Inc. | Results Analysis Shows BYDUREON(TM) Was Not Associated with Clinically Relevant QT Prolongation in Patients with Type 2 Diabetes: Results Presented at ADA 2011 alkermes.com ↗
Separately, results from the DURATION-3 study showed that at 84 weeks, patients treated with BYDUREON experienced significantly greater A1C reduction from baseline, sustained weight loss and a lower risk of hypoglycemia than patients treated with Lantus® (insulin glargine). |
| 2011-04-28 | Novo Nordisk A/S | Results Novo Nordisk increased operating profit by 24% in the first quarter of 2011 novonordisk.com ↗
The meta-analysis confirmed that Degludec is associated with a lower risk of hypoglycaemia compared to insulin glargine, both on the total number of confirmed hypoglycaemic events, and on the number of confirmed nocturnal hypoglycaemic events. |
| 2010-12-22 | Novo Nordisk A/S | Results Degludec giver væsentligt nedsat risiko for natlig hypoglykæmi sammenlignet med insulin glargin i to langtidsstudier novonordisk.com ↗
Novo Nordisk har i dag rapporteret kliniske resultater fra to 52-ugers fase 3a treat-to-target-studier, der har sammenlignet Degludec, en ultralangtidsvirkende basal insulin, med insulin glargin i basal/bolus-behandling af type 1- og type 2-diabetes. |
| 2010-12-22 | Novo Nordisk A/S | Results Degludec significantly reduces risk of hypoglycaemia during the night compared to insulin glargine in two long-term studies novonordisk.com ↗
Novo Nordisk today announced clinical results from two 52-week phase 3a treat-to-target studies comparing Degludec, an ultra long-acting basal insulin, to insulin glargine in basal-bolus treatment of type 1 and type 2 diabetes. |
| 2010-09-14 | Alkermes, Inc. | Results BYETTA® and BYDUREON™ to be Featured in More Than a Dozen Study Presentations at EASD 2010 alkermes.com ↗
Exenatide Added to Insulin Glargine-Treated Patients with Type 2 Diabetes Provided Excellent Fasting and Postprandial Control with Weight Loss and no Increased Risk of Hypoglycaemia |
| 2010-06-26 | Eli Lilly and Company | Results Type 2 Diabetes Patients With Long-Standing Disease Achieved Glycemic Control When BYETTA(R) Was Added to Lantus(R) lilly.com ↗
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA(R) (exenatide) injection added to Lantus(R) (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. |
| 2010-06-26 | Eli Lilly and Company | Results Improvement in Beta-Cell Function Observed After Three Years of BYETTA(R) Therapy: Data Presented at ADA 2010 lilly.com ↗
Lantus had no effect on insulin sensitivity or disposition index. |
| 2009-07-20 | Eli Lilly and Company | Results Exenatide Once Weekly Provided Superior Glucose Control Compared To Lantus(R) in Head-to-Head DURATION-3 Study lilly.com ↗
At the end of the study, patients treated with exenatide once weekly achieved a mean A1C of 6.8 percent compared with a mean A1C of 7.0 percent in those treated with Lantus. |
| 2009-07-20 | Alkermes, Inc. | Results Exenatide Once Weekly Provided Superior Glucose Control Compared To Lantus(R) in Head-to-Head DURATION-3 Study alkermes.com ↗
Patients randomized to exenatide once weekly experienced a statistically superior reduction in A1C, a measure of average blood sugar over three months, of 1.5 percentage points from baseline, compared to a reduction of 1.3 percentage points for Lantus after completing 26 weeks of treatment. |
| 2007-09-21 | Eli Lilly and Company | Results One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function lilly.com ↗
Study findings showed one year of exenatide therapy, as compared to insulin glargine, markedly improved different indices of beta-cell function, along with similar glycemic improvement. |
| 2007-06-24 | Eli Lilly and Company | Results BYETTA® Study Showed Comparable Blood Glucose Control to Insulin lilly.com ↗
Study findings showed comparable improvements in blood sugar control with BYETTA and insulin glargine therapies, with weight loss and lower incidence of hypoglycemia associated with BYETTA. |
| 2007-06-21 | Novo Nordisk A/S | Results Liraglutide giver en væsentligt bedre blodsukkerregulering end insulin glargine i fase 3-studie novonordisk.com ↗
HbA1c-reduktionen i liraglutide-gruppen var mere end 0,2 procentpoint bedre end i insulin glargine-gruppen - en statistisk signifikant forskel. |
| 2007-06-21 | Novo Nordisk A/S | Results Liraglutide provides significantly better glucose control than insulin glargine in phase 3 study novonordisk.com ↗
The HbA1c reduction achieved in the liraglutide group was more than 0.2 percentage points better than in the insulin glargine group, a difference which is statistically significant. |
| 2005-09-12 | Eli Lilly and Company | Results Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Insulin Glargine lilly.com ↗
Both treatments were effective in lowering blood sugar, and patients taking exenatide experienced weight reductions while those on insulin glargine gained weight. |
| 2005-06-10 | Eli Lilly and Company | Results Study Shows BYETTA(TM) Improves Blood Sugar Levels as Effectively as Insulin Glargine lilly.com ↗
Both treatments were effective in lowering blood sugar, and patients taking BYETTA experienced weight reductions while those on insulin glargine gained weight. |
| 2004-07-26 | Eli Lilly and Company | Results Successful Completion of Study Comparing Exenatide to Insulin Glargine Results in Milestone Payment from Lilly to Amylin lilly.com ↗
Results demonstrate that both exenatide and insulin glargine achieved similar A1C reductions, with endpoint A1Cs of 7.2 percent for both groups at the end of the study. |
| 2004-06-05 | Eli Lilly and Company | Results Humalog Mix75/25 vs. Lantus in Type 2 Diabetes lilly.com ↗
In two separate studies comparing Humalog® Mix75/25™ to Lantus, the former did a better job than the latter of helping patients with type 2 diabetes lower their blood sugar levels and achieve better diabetes control over time. |
All press releases naming this drug 141 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 141 releases opens the full record — a long page | ||
Evidence & citations 56 cited values
Every value below carries the sentence it was read from. 681 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin glargine | “The Glargine/Lispro Protocol included 0.2 unit/kg/day as insulin glargine once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more...” NCT01810952 ↗494“The differences between insulin glargine U300 and insulin degludec U100 in impact on the glycaemic variability, arterial stiffness and the lipid profiles in insulin naïve...” PMID 33926446 ↗ Apr 2021 “INTRODUCTION: LY2963016 insulin glargine (LY IGlar), a biosimilar of Lantus® insulin glargine (IGlar), demonstrated comparable efficacy and safety versus the reference product...” PMID 35471721 ↗ Apr 2022 “Discharge on 0.3 U/kg of admission long acting insulin glargine or detemir (provided by diabetes and endocrine clinic) regardless of participant's home insulin regimen at the...” NCT03001323 ↗ “Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes...” PMID 38558508 ↗ Apr 2024 “Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection of insulin glargine or...” NCT03463564 ↗ “Lilly insulin glargine (LY IGlar; Basaglar®) and the reference insulin glargine product (IGlar; Lantus®) are basal insulin glargine analogs with identical amino acid sequence...” PMID 31119716 ↗ Aug 2019 “The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for...” NCT07112339 ↗ “INTRODUCTION: LY2963016 insulin glargine (LY IGlar) and Lantus® (IGlar), both with identical primary amino acid sequences, were compared in two phase 3 studies for intrapatient...” PMID 29855972 ↗ May 2018 “The study aims to compare insulin glargine, a long-acting basal insulin with approximately 24-hour duration, and insulin degludec, an ultra-long-acting basal insulin with about...” NCT07599891 ↗ “Levemir (insulin detemir) and Lantus (insulin glargine) are two relatively new insulin analogs known for their consistent and reproducible absorption profiles and steady...” NCT00564018 ↗ |
| Known as | Basaglar | “In 2022, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll).” NCT06674135 ↗2“receive insulin glargine (Basaglar, Eli Lilly, Indianapolis, IN, USA)” PMID 42409045 ↗ Jul 2026 “basal long-acting insulin Basaglar/Lantus with gliclazide MR 60 mg OD” NCT03819790 ↗ |
| Known as | Basalin | “AIM: To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product...” PMID 38558508 ↗ Apr 20242“Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced...” PMID 37735841 ↗ Sep 2023 |
| Known as | Gan & Lee insulin glargine | “0.4 IU/kg Gan & Lee insulin glargine injection SC, Lantus 0.4 IU/kg injection SC” NCT02506647 ↗ |
| Known as | Gan & Lee Insulin Glargine Injection | “Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen.” NCT03371082 ↗ |
| Known as | GL Glargine | “AIM: To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product...” PMID 38558508 ↗ Apr 2024 |
| Known as | GL-Gla | “Three phase 1, randomized, double-blind, three-period crossover trials compared single doses of the proposed biosimilar insulin analogues aspart (GL-Asp, n = 36), lispro...” PMID 37735841 ↗ Sep 2023 |
| Known as | GLA | “Patients in Group A (glargine-regular regimen) received insulin glargine (GLA) once in the evening (8:00 pm) and regular insulin 30 minutes before their three main meals.” NCT05709938 ↗2“allocated to treatment with either MET 1,000 mg b.i.d. (n = 36) or insulin glargine (GLA) at bedtime” PMID 23430192 ↗ Feb 2013 “Insulin glargine, dose individually adapted to reach treatment goal (FBG \< 100 mg/dL)” NCT00941148 ↗ |
| Known as | Gla-100 | “This study assessed the efficacy and safety of LixiLan, a fixed-ratio, titratable, combination of 2 units insulin glargine (Gla-100) and 1 μg lixisenatide administered once...” PMID 27284114 ↗ Jun 201611“OBJECTIVE: To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes on basal...” PMID 25078900 ↗ Jul 2014 “AIMS: To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of glargine 100 U/ml (Gla-100) in insulin-naïve people with type 2 diabetes using...” PMID 25641260 ↗ Feb 2015 “OBJECTIVE: SENIOR compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in older people (≥65 years old) with type 2 diabetes.” PMID 29895556 ↗ Jun 2018 “Gla-100 will be supplied as a 3 mL sterile aqueous solution for SC injection in a pre-filled disposable Gla-100 SoloStar® pen containing 300 U insulin glargine (100 U/mL).” NCT06671587 ↗ “AIM: To compare efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of insulin glargine 100 U/ml (Gla-100) in Japanese adults with type 1 diabetes.” PMID 26662964 ↗ Feb 2016 “Insulin glargine 300 U/mL (Gla-300) offers a flatter pharmacodynamic profile than insulin glargine 100 U/mL (Gla-100).” PMID 28661585 ↗ Aug 2017 “The baseline insulin glargine 100 U/mL (Gla-100) dose increased significantly” PMID 35943899 ↗ Aug 2022 “insulin glargine 100 U/mL (Gla-100) is as safe as the standard starting dose” PMID 34286454 ↗ Jul 2021 “insulin glargine 100 U mL (-1) (Gla-100)” PMID 26055218 ↗ Jun 2015 “insulin glargine 100 U/mL (Gla-100)” PMID 29649539 ↗ Apr 2018 |
| Known as | Gla-300 | “The clinical benefits of insulin glargine 300 U/ml (Gla-300) have been confirmed in randomized clinical trials (EDITION and BRIGHT) and real-world studies (ATOS, Toujeo-1, and...” PMID 40338497 ↗ May 202516“OBJECTIVE: To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes on basal...” PMID 25078900 ↗ Jul 2014 “AIMS: To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of glargine 100 U/ml (Gla-100) in insulin-naïve people with type 2 diabetes using...” PMID 25641260 ↗ Feb 2015 “OBJECTIVE: SENIOR compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in older people (≥65 years old) with type 2 diabetes.” PMID 29895556 ↗ Jun 2018 “The TOP1 study investigated the effect of switching from twice-daily (BID) basal insulin to once daily (OD) insulin glargine 300 U/mL (Gla-300) on glycemic control and quality of life.” PMID 38982528 ↗ Jul 2024 “AIM: To compare efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of insulin glargine 100 U/ml (Gla-100) in Japanese adults with type 1 diabetes.” PMID 26662964 ↗ Feb 2016 “OBJECTIVE: To compare insulin glargine 300 units/mL (Gla-300) versus insulin degludec 100 units/mL (IDeg-100) in this first head-to-head randomized controlled trial.” PMID 30104294 ↗ Aug 2018 “To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available” PMID 32100192 ↗ Feb 2020 “Insulin-naive adults with type 2 diabetes and A1c ≥8% were randomized 1:1 to insulin glargine 300 U/mL (Gla-300) or standard-of-care basal insulin (SOC-BI).” PMID 33509703 ↗ Dec 2020 “AIM: To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) in people with suboptimally controlled type 2 diabetes (T2D) in China.” PMID 39075925 ↗ Jul 2024 “Objective: To compare real-world outcomes with newer (insulin glargine 300 U/mL; Gla-300) versus standard of care (SoC) basal insulins (BIs)” PMID 31865758 ↗ Jan 2020 |
| Known as | GLAR | “Data from a multi-center, randomized clinical trial comparing the efficacy/safety of biphasic insulin aspart 70/30 (BIAsp 70/30) vs. glargine (Glar) among insulin naïve type 2...” PMID 17286868 ↗ Feb 20071“receiving insulin glargine (GLAR) + metformin (MET).” PMID 20357372 ↗ Mar 2010 |
| Known as | glarg | “twice-daily biphasic insulin aspart 30 (30% soluble and 70% protaminated insulin aspart; BIAsp 30) plus metformin (met) was compared with once-daily insulin glargine (glarg)...” PMID 17115351 ↗ Oct 2006 |
| Known as | glargine | “The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with...” NCT01068665 ↗82“The DURABLE (Assessing the DURAbility of Basal vs Lispro Mix 75/25 Insulin Efficacy) trial will compare the ability of glargine once daily vs lispro mix 75/25 (75% insulin...” PMID 19885269 ↗ Sep 2008 “Patients were randomized to receive a premixed human insulin formulation with 70% intermediate insulin plus 30% regular insulin (Mixtard 30®, Novo Nordisk) or a basal-bolus...” NCT02333851 ↗ “This 52-week multinational, randomised, open-label, parallel-group, non-inferiority trial compared clinical outcomes following supplementation of oral glucose-lowering drugs...” PMID 18204830 ↗ Jan 2008 “Discharge on 0.3 U/kg of admission long acting insulin glargine or detemir (provided by diabetes and endocrine clinic) regardless of participant's home insulin regimen at the...” NCT03001323 ↗ “clinicians can choose between glucagon-like peptide-1 (GLP-1) receptor agonists and basal insulins. In DURATION-3, exenatide once weekly was compared with insulin glargine...” PMID 24731672 ↗ Apr 2014 “Nine patients with T2DM currently receiving iPremix formulations and poor glycemic control were switched to once-daily injected lixisenatide (Lixi) and basal insulin analogue...” PMID 28357772 ↗ Mar 2017 “The primary endpoint was assessment of the noninferiority of dulaglutide 1.5 mg as measured by change in HbA1c, compared with insulin glargine (glargine), using a 0.4%...” PMID 31228090 ↗ Jun 2019 “AIMS: This study assessed the efficacy and safety of once-daily insulin initiation using insulin detemir (detemir) or insulin glargine (glargine) added to existing metformin in...” PMID 23421331 ↗ Mar 2013 “This randomized, double-blind, crossover trial compared the within-subject variability of detemir and insulin glargine (glargine) in pharmacokinetic properties in children and...” PMID 18761644 ↗ Aug 2008 “The aim of present study is to assess whether if basal insulin, glargine, could improve insulin secretory function of β-cells compared with glimepiride when metformin alone was failed.” PMID 24445656 ↗ Jan 2014 |
| Known as | Glargine and insulin aspart or lispro | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00464854 ↗ |
| Known as | Glargine insulin | “Our trial is designed to compare morning NPH insulin (isophane insulin) with conventional therapy of basal glargine insulin on both continuous blood glucose levels and...” NCT01963728 ↗7“To determine whether the use of glargine insulin as a basal insulin would result in a comparable HbA1c and less glycemic variation and hypoglycemia than ultralente insulin, 22...” PMID 15616226 ↗ Jan 2005 “Single dose glargine insulin (basal component) + regular insulin within total parenteral nutrition (TPN) reservoir (prandial component).” NCT02706119 ↗ “Glargine insulin; 300 Units/mL, average dose: 10-20 U/day; Insulin lispro 100 Units/mL, average dose: 10-30 U/day” NCT05457933 ↗ “with long acting basal glargine insulin and pre-meal insulin analogues” NCT00464854 ↗ “Drug: Glargine insulin was administered per above.” NCT01810952 ↗ “Glargine insulin vs regular insulin” NCT00177398 ↗ “Drug: Glargine insulin” NCT07599891 ↗ |
| Known as | glargine U100 | “compare day-to-day fasting SMBG variability between treatments with insulin degludec (degludec) and insulin glargine 100 units/mL (glargine U100)” PMID 30362250 ↗ Nov 20182“Participants were randomly assigned in a 1:1 ratio to receive once-weekly insulin icodec or once-daily insulin glargine U100.” PMID 37356066 ↗ Jun 2023 “insulin glargine 100 units/mL (glargine U100)” PMID 30097995 ↗ Aug 2018 |
| Known as | Glargine U300 | “The differences between insulin glargine U300 and insulin degludec U100 in impact on the glycaemic variability, arterial stiffness and the lipid profiles in insulin naïve...” PMID 33926446 ↗ Apr 20211“Glargine U300 is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.” NCT05036876 ↗ |
| Known as | Glaritus | “between the two long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with type1 diabetes” NCT01357603 ↗ |
| Known as | GP-Gla | “Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus.” PMID 32027167 ↗ Feb 2020 |
| Known as | GP40061 | “Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus.” PMID 32027167 ↗ Feb 2020 |
| Known as | HOE901 | “Insulin glargine U300 (new formulation of insulin glargine) HOE901” NCT02227212 ↗28“Insulin glargine/Lixisenatide (HOE901/AVE0010)” NCT02752412 ↗ “Insulin glargine/Lixisenatide (HOE901/AVE0010)” NCT02749890 ↗ “Insulin glargine/lixisenatide (HOE901/AVE0010)” NCT02058160 ↗ “Insulin glargine new formulation (HOE901)” NCT01689142 ↗ “Insulin glargine new formulation (HOE901)” NCT01689129 ↗ “Insulin glargine new formulation HOE901” NCT01838083 ↗ “Insulin Glargine (HOE901)/NPH Insulin” NCT00941369 ↗ “Insulin Glargine (HOE901) [Lantus]” NCT00949442 ↗ “Drug: INSULIN GLARGINE (HOE901)” NCT00950534 ↗ “insulin glargine U200 HOE901” NCT02201199 ↗ |
| Known as | HOE901 - U100 | “Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting...” NCT01676220 ↗5“Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.” NCT01499082 ↗ “Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months” NCT01683266 ↗ “Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning” NCT01658579 ↗ “Lantus (HOE901-U100, insulin glargine 100 U/mL)” NCT01499095 ↗ “Insulin Glargine (HOE901 - U100)” NCT02320721 ↗ |
| Known as | HOE901-U300 | “morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control” NCT02688933 ↗5“HOE901-U300 (new formulation of insulin glargine)” NCT01676220 ↗ “HOE901-U300 (new formulation of insulin glargine)” NCT01499095 ↗ “HOE901-U300 (Insulin glargine new formulation)” NCT01683266 ↗ “Insulin Glargine (HOE901 - U300)” NCT02320721 ↗ “Insulin Glargine (HOE901 - U300)” NCT07173712 ↗ |
| Known as | IGla | “This treat-to-target study compared the efficacy and safety of insulin detemir (IDet) and insulin glargine (IGla) in a basal-bolus (insulin aspart) regimen in type 2 diabetes.” PMID 19565569 ↗ Sep 2009 |
| Known as | IGlar | “The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with...” NCT01068665 ↗31“The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes...” NCT01068678 ↗ “AIMS: To assess efficacy and safety of fixed-ratio (1:1) combination insulin glargine and lixisenatide (iGlarLixi) compared to insulin glargine U100 (iGlar), with metformin, in...” PMID 32072742 ↗ Sep 2020 “participants (mean: 45.8 years old, A1C 8.4%, fasting plasma glucose [FPG] 9.9 mmol/L, BMI 26.9 kg/m(2)) received subcutaneous injections of IDeg(A) (600 μmol/L; n = 59),...” PMID 21270174 ↗ Jan 2011 “INTRODUCTION: LY2963016 insulin glargine (LY IGlar), a biosimilar of Lantus® insulin glargine (IGlar), demonstrated comparable efficacy and safety versus the reference product...” PMID 35471721 ↗ Apr 2022 “a novel titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi), compared with both components, iGlar and Lixi, given separately in type 2...” PMID 27527848 ↗ Aug 2016 “The objective of this study was to compare initiation of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) vs insulin glargine U100 (iGlar) along with...” PMID 35752566 ↗ Feb 2022 “We examined insulin antibody formation in patients with type 1 (T1D) or type 2 diabetes (T2D) treated with once-daily insulin degludec (IDeg) or insulin glargine (IGlar) to...” PMID 26663320 ↗ Feb 2016 “This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either...” NCT01704417 ↗ “Insulin degludec (IDeg) is a new-generation basal insulin with an ultra-long duration of action. We compared the pharmacodynamic (PD) variability of IDeg and insulin glargine...” PMID 22594461 ↗ Jun 2012 “Nine patients with T2DM currently receiving iPremix formulations and poor glycemic control were switched to once-daily injected lixisenatide (Lixi) and basal insulin analogue...” PMID 28357772 ↗ Mar 2017 |
| Known as | IGlar U100 | “BACKGROUND: Durability of glycaemic control might reduce disease burden and improve long-term outcomes. DUAL VIII investigated the durability of insulin degludec plus...” PMID 31189519 ↗ Jun 20192“IDegLira was compared with continued up-titration of insulin glargine (IGlar U100) in DUAL V” PMID 31705547 ↗ Nov 2019 “or once-daily insulin glargine 100 units/mL (IGlar U100)” PMID 33875484 ↗ Apr 2021 |
| Known as | IGlar-300 | “There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300).” PMID 35802405 ↗ Jul 2022 |
| Known as | IGlar-U300 | “AIM: To compare day-to-day and within-day variability in glucose-lowering effect between insulin degludec (IDeg) and insulin glargine 300 U/mL (IGlar-U300) in type 1 diabetes.” PMID 28295934 ↗ Apr 2017 |
| Known as | iGlarLixi | “To evaluate efficacy and safety of LixiLan (iGlarLixi), a novel titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi), compared with both...” PMID 27527848 ↗ Aug 2016 |
| Known as | Insulin analog glargine | “Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.” NCT01352663 ↗ |
| Known as | insulin glargine 300U/ml | “initiated on once-daily bedtime insulin glargine 300U/ml (Gla-300) versus neutral protamine Hagedorn (NPH) insulin” PMID 33738774 ↗ Mar 2021 |
| Known as | insulin glargine U100 | “Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®)” NCT04136067 ↗2“insulin glargine U100 (glargine U100)” PMID 37156252 ↗ May 2023 “insulin glargine U100 (IGlar)” PMID 27595693 ↗ Jun 2016 |
| Known as | Insulin glargine U300 | “Insulin glargine U300 (new formulation of insulin glargine) HOE901” NCT02227212 ↗ |
| Known as | insulin glargine U300/ml | “This is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1) pilot study.The study will compare glycemic variability in patients treated with...” NCT03389490 ↗ |
| Known as | insulin glargine-Lantus | “insulin glargine (Lantus)” NCT00000620 ↗ |
| Known as | Insulin glargine/lixisenatide Fixed Ratio Combination | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02058147 ↗ |
| Known as | insulin glargine: Lamtus | “insulin glargine: Lamtus” NCT01461616 ↗ |
| Known as | Insuline glargine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00272077 ↗ |
| Known as | Lantus | “12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously...” NCT00467376 ↗89“This study will compare how well regular insulin will compare to glargine (Lantus®) once daily plus glulisine (Apidra®) insulin before meals in hospitalized patients with type...” NCT00394407 ↗ “Lilly insulin glargine (LY IGlar; Basaglar®) and the reference insulin glargine product (IGlar; Lantus®) are basal insulin glargine analogs with identical amino acid sequence...” PMID 31119716 ↗ Aug 2019 “INTRODUCTION: LY2963016 insulin glargine (LY IGlar) and Lantus® (IGlar), both with identical primary amino acid sequences, were compared in two phase 3 studies for intrapatient...” PMID 29855972 ↗ May 2018 “The AT.LANTUS study investigated optimal methods to initiate and maintain insulin glargine (LANTUS, glargine, Sanofi-aventis, Paris, France) therapy using two treatment algorithms.” PMID 18355327 ↗ Mar 2008 “Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen.” NCT03371082 ↗ “the long-acting "basal" insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been shown to facilitate glycemic control” NCT00590044 ↗ “Participants will get either the new insulin 965 or insulin glargine - a medicine that doctors already can prescribe (Lantus®).” NCT04575181 ↗ “The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.” NCT02666430 ↗ “pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.” NCT00135096 ↗ “between the two long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with type1 diabetes” NCT01357603 ↗ |
| Known as | Lantus (glargine) | “Lantus (glargine)” NCT01378117 ↗ |
| Known as | Lantus (insulin glargine) | “Lantus (insulin glargine)” NCT00979628 ↗ |
| Known as | Lantus is brand name for Glargine | “Lantus is brand name for Glargine” NCT00338104 ↗ |
| Known as | LantusT | “either insulin glargine (LantusT) or NPH-insulin (Protaphan)” NCT00553020 ↗ |
| Known as | MYL-1501D | “BACKGROUND: MYL-1501D is a proposed biosimilar to insulin glargine.” PMID 34174848 ↗ Jun 2021 |
| Known as | Mylan insulin glargine | “Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per...” NCT02666430 ↗ |
| Known as | Mylan's insulin glargine | “The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.” NCT02666430 ↗ |
| Known as | SA IGlar | “To compare efficacy and safety of Basaglar® [insulin glargine 100 units/mL; LY insulin glargine (LY IGlar)] to Lantus® [insulin glargine 100 units/mL; SA insulin glargine (SA...” PMID 29542012 ↗ Mar 2018 |
| Known as | SA insulin glargine | “To compare efficacy and safety of Basaglar® [insulin glargine 100 units/mL; LY insulin glargine (LY IGlar)] to Lantus® [insulin glargine 100 units/mL; SA insulin glargine (SA...” PMID 29542012 ↗ Mar 2018 |
| Known as | Sa-Gla | “Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus.” PMID 32027167 ↗ Feb 20202“AIM: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM).” PMID 29761615 ↗ Jun 2018 “originator insulin glargine, Lantus (Sa-Gla), in people with type 1” PMID 29766635 ↗ Jun 2018 |
| Known as | Sanofi glargine | “Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus.” PMID 32027167 ↗ Feb 2020 |
| Known as | Toujeo | “Drug: Insulin Glargine 300 UNT/ML [Toujeo]” NCT05155917 ↗1“Toujeo” NCT02688933 ↗ |
| Known as | Toujeo SoloStar | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03328845 ↗ |
| Known as | US-approved Lantus | “The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®.” NCT01688635 ↗ |
| Action | Inhibit | “Glargine lowers blood glucose by mainly inhibiting EGP” PMID 20357371 ↗ Mar 2010 |
| Modality | Protein / enzyme biologic | “Lantus (insulin glargine [rDNA origin] injection)” NCT00046501 ↗ |
| Route | Subcutaneous | “Insulin glargine once daily by subcutaneous injection” NCT00069784 ↗ |