Drugs / Insulin Lispro
Insulin Lispro
also known as
Humalog · lispro · LY900014 · Insulin Lispro Protamine Suspension · Lispro Insulin · LIS · URLi · BioChaperone insulin lispro · +15 more
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diabetes mellitus 2 milestones | |||||
| Filed | EU (EMA) | — | diabetes mellitus | 2023-10-09 | “submitted the Marketing Authorization Application (hereinafter referred to as "MAA") of Insulin lispro biosimilar to the European Medicines Agency” ganlee.com ↗ |
| Filed | US (FDA) | — | diabetes mellitus | 2023-06-01 | “BLA submission of Gan & Lee proposed biosimilar Insulin Lispro subcutaneous Injection was accepted for filing by the US FDA” ganlee.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (5) | US (FDA) | HUMALOG KWIKPEN | — | 2000-04-04 – 2012-10-14 | fda.gov ↗ |
| Approved | US (FDA) | HUMALOG KWIKPEN | — | 1996-06-14 | fda.gov ↗ |
| Approved | EU (EMA) | Humalog | — | 1996-04-30 | europa.eu ↗ |
Trials 102 · started per year
today
EU approved 1996
US approved 1996
1
2
4
2
1
2
5
9
3
9
3
2
7
12
6
3
4
6
8
5
2
2
3
1
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 130 trials · 6 met primary | ||||||
| Phase 1 | NCT07090824 | Oct 2025 → May 2026 | type 1 diabetes mellitus | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT05262387 | Feb 2022 → Mar 2023 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT04501107 | Aug → Nov 2020 | type 1 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Phase 1 | NCT04161976 | Dec 2019 → Jul 2020 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03741478 | Oct 2019 → Jul 2026 overdue | — | Centre for Addiction and Mental Health | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04235439 | Apr → Jul 2019 | diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | Met primary |
| Phase 1 | NCT03616977 | Aug → Oct 2018 | — | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT02623452 | Jan → Apr 2018 | type 1 diabetes mellitus | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02623465 | Jan → Apr 2018 | type 2 diabetes mellitus | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02623478 | Jan → Apr 2018 | type 1 diabetes mellitus | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03334448 | Dec 2017 → Mar 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03367390 | Nov 2017 → Feb 2018 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03232983 | Aug → Nov 2017 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03179332 | Jun → Sep 2017 | type 1 diabetes mellitus | Adocia | Completed | Met primary |
| Phase 1 | NCT02752087 | Apr → May 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02603510 | Nov 2015 → Apr 2016 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02562326 | Sep 2015 → Jan 2016 | type 2 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Phase 1 | NCT02470637 | Jun → Sep 2015 | type 1 diabetes mellitus | Mannkind Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02317575 | Jan → Apr 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02293551 | Dec 2014 → Sep 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02197520 | Jul 2014 → Jun 2015 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02152384 | Jun → Dec 2014 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02111083 | May → Aug 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01981031 | Nov → Dec 2013 | type 1 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Phase 1 | NCT02131948 | Nov 2013 → Jul 2014 | diabetes mellitus | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1 | NCT01871493 | Jun → Sep 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01792323 | Aug → Nov 2011 | type 1 diabetes mellitus | Medical University of Graz | Completed | No outcome recorded |
| Phase 1 | NCT00979875 | Sep 2009 → Feb 2010 | — | Halozyme Therapeutics | Completed | Met primary |
| Phase 1 | NCT00862849 | Mar → Jun 2009 | diabetes mellitus | Halozyme Therapeutics | Completed | Met primary |
| Phase 1 | NCT00803972 | Nov 2008 → Aug 2009 | — | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT02213146 | Aug → Dec 2014 | type 1 diabetes mellitus | Adocia | Completed | Met primary |
| Phase 216 trials · 3 met primary | ||||||
| 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 | NCT04585776 | Oct 2020 → May 2021 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT03938740 | Mar → Dec 2019 | type 1 diabetes mellitus | Diasome Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03682640 | Sep 2018 → Dec 2021 | type 1 diabetes mellitus | Uppsala University | Unknown | No outcome recorded |
| Phase 2 | NCT02221323 | Sep → Nov 2014 | diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 2 | NCT02146651 | May → Jul 2014 | type 1 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Phase 2 | NCT01756105 | Jun 2012 → Feb 2018 | gestational diabetes | University Hospital, Strasbourg, France | Terminated | No outcome recorded |
| Phase 2 | NCT01194258 | Aug 2010 → Aug 2011 | type 2 diabetes mellitus | Halozyme Therapeutics | Completed | Met primary |
| Phase 2 | NCT01194245 | Aug 2010 → Aug 2011 | type 1 diabetes mellitus | Halozyme Therapeutics | Completed | Met primary |
| Phase 2 | NCT00883558 | May 2009 → Feb 2010 | type 1 diabetes mellitus | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00774800 | Oct 2008 → Mar 2009 | type 1 diabetes mellitus | Halozyme Therapeutics | Completed | Met primary |
| Phase 2 | NCT00747006 | Sep 2008 → Feb 2011 | type 1 diabetes mellitus, type 2 diabetes mellitus | Mannkind Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00662857 | Apr → Nov 2008 | type 1 diabetes mellitus | Mannkind Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00553488 | Sep → Dec 2007 | type 1 diabetes mellitus | Becton, Dickinson and Company | Completed | No outcome recorded |
| Phase 2 | NCT01000922 | Jun 2006 → Jan 2008 | diabetes mellitus | Biodel | Completed | No outcome recorded |
| Phase 2 | NCT00063128 | Apr 2003 → Apr 2004 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03262116 | Mar → Jul 2019 | type 1 diabetes mellitus | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 2/3 | NCT00447213 | Apr 2007 → May 2008 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 318 trials · 6 met primary · 1 missed | ||||||
| Phase 3 | NCT04605991 | Nov 2020 → Feb 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT04254380 | Dec 2019 → Jan 2020 | type 1 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Withdrawn | No outcome recorded |
| Phase 3 | NCT03433677 | Feb → Sep 2018 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT02229227 | Nov 2014 → Jul 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02192424 | Jul 2014 → Aug 2020 | type 2 diabetes mellitus | Mount Sinai Hospital, Canada | Completed | No outcome recorded |
| Phase 3 | NCT01755468 | Apr 2013 → Oct 2017 | type 2 diabetes mellitus | Mount Sinai Hospital, Canada | Completed | No outcome recorded |
| Phase 3 | NCT01481779 | Jan 2012 → May 2013 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01136746 | Mar → Nov 2011 | hyperglycemia | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01134107 | Nov 2010 → Dec 2011 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01110746 | Feb → Jun 2010 | type 1 diabetes mellitus | Biodel | Completed | No outcome recorded |
| Phase 3 | NCT00700622 | May 2008 → Nov 2009 | type 1 diabetes mellitus | Mannkind Corporation | Terminated | Met primary |
| Phase 3 | NCT00666718 | Apr 2008 → Feb 2010 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00494013 | Aug 2007 → Sep 2008 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00510952 | Aug 2007 → Oct 2008 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00487240 | Jun 2007 → Aug 2008 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00191581 | Mar 2005 → Apr 2006 | type 1 diabetes mellitus, type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00097071 | Oct 2004 → May 2006 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00071448 | Jun 2002 → Jun 2004 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 420 trials · 3 met primary · 5 missed | ||||||
| Phase 4 | NCT04019821 | Jan 2020 → Jan 2023 | type 1 diabetes mellitus | Medical University of Warsaw | Completed | No outcome recorded |
| Phase 4 | NCT04157738 | Nov 2019 → Dec 2020 | type 1 diabetes mellitus | Emory University | Completed | Met primary |
| Phase 4 | NCT03670641 | Mar 2019 → Jul 2020 | type 2 diabetes mellitus | Sandra Sobel | Completed | No outcome recorded |
| Phase 4 | NCT03509324 | Mar → Jun 2015 | type 2 diabetes mellitus | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 4 | NCT02276859 | Oct 2014 → Sep 2015 | type 1 diabetes mellitus | Medical University of Warsaw | Completed | No outcome recorded |
| Phase 4 | NCT04739241 | Jan 2014 → Apr 2018 | type 2 diabetes mellitus | Consorci Sanitari Integral | Completed | No outcome recorded |
| Phase 4 | NCT02165566 | Mar 2013 → Mar 2014 | hyperglycemia | University of Roma La Sapienza | Completed | Met primary |
| Phase 4 | NCT01215955 | Dec 2010 → Jan 2013 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT01159938 | Oct 2010 → Feb 2013 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT01121835 | Feb 2010 → Mar 2012 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01613807 | Oct 2008 → Jun 2010 | gestational diabetes | Sansum Diabetes Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT00664534 | Apr 2008 → Nov 2010 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00607087 | Jan 2008 → Jun 2009 | type 1 diabetes mellitus | Sanofi | Completed | Missed primary |
| Phase 4 | NCT00841919 | Dec 2006 → Mar 2009 | type 2 diabetes mellitus | Cook County Health | Completed | Met primary |
| Phase 4 | NCT00110370 | Apr 2004 → Apr 2006 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00191464 | Dec 2003 → Sep 2005 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00191178 | Aug 2003 → Jul 2005 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT02962921 | Feb → May 2003 | cardiac ventricle disorder, diabetes mellitus | Rambam Health Care Campus | Completed | No outcome recorded |
| Phase 4 | NCT00191282 | Oct 2002 → Oct 2007 | acute myocardial infarction, type 2 diabetes mellitus | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00036504 | Aug 2001 → Aug 2002 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase not applicable15 trials · 1 met primary | ||||||
| — | NCT06419777 | Sep 2024 → May 2026 overdue | gestational diabetes | Thomas Jefferson University | Recruiting | No outcome recorded |
| — | NCT06251635 | Jun 2024 → Dec 2026 expected | type 2 diabetes mellitus | Centre for Addiction and Mental Health | Active not recruiting | No outcome recorded |
| — | NCT06765655 | Apr 2024 → Jan 2025 overdue | hyperglycemia | St. Peter's Hospital, Albany, NY | Enrolling by invitation | No outcome recorded |
| — | NCT05571878 | Sep 2021 → May 2025 | major depressive disorder | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| — | NCT03229850 | Feb 2021 → Jan 2025 | diabetes mellitus, localized lipodystrophy | Graydon Meneilly | Withdrawn | No outcome recorded |
| — | NCT04200313 | Mar 2020 → Oct 2021 | type 1 diabetes mellitus | Jaeb Center for Health Research | Completed | Met primary |
| — | NCT03604575 | Aug → Dec 2016 | — | Geropharm | Completed | No outcome recorded |
| — | NCT03102476 | Jun 2016 → Feb 2018 | type 1 diabetes mellitus | University of Hull | Completed | No outcome recorded |
| — | NCT02518022 | Sep 2015 → Jun 2016 | hypoglycemia, type 1 diabetes mellitus | Kinderkrankenhaus auf der Bult | Withdrawn | No outcome recorded |
| — | NCT02248454 | Sep 2014 → Apr 2015 | type 1 diabetes mellitus | Joslin Diabetes Center | Completed | No outcome recorded |
| — | NCT01636596 | Sep 2013 → Jan 2015 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Louisiana State University Health Sciences Center Shreveport | Withdrawn | No outcome recorded |
| — | NCT01974544 | May 2013 → Dec 2015 | type 2 diabetes mellitus | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| — | NCT01303042 | Feb 2011 → Dec 2013 | type 2 diabetes mellitus | Aichi Gakuin University | Unknown | No outcome recorded |
| — | NCT01149005 | Jun 2010 → Jun 2015 | cystic fibrosis, glucose intolerance, lung disorder | Hadassah Medical Organization | Unknown | No outcome recorded |
| — | NCT01045954 | Jan → Aug 2010 | type 1 diabetes mellitus | Diabetes Care Center | Unknown | No outcome recorded |
| Comparator or background therapy177 trials | ||||||
| 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 | NCT06945406 Background | May 2025 → Mar 2027 expected | type 1 diabetes mellitus, type 2 diabetes mellitus | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1 | NCT05689424 Comparator | Feb 2025 → Jun 2026 overdue | type 1 diabetes mellitus | University of California, San Diego | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06280703 Background | May 2024 → Oct 2026 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05373186 Comparator | May → Dec 2022 | — | Adocia | Completed | No outcome recorded |
| Show all 177 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 76
| Date | Issuer | Release |
|---|---|---|
| 2026-06-08 | Adocia | Results ADOCIA Announces THDB0206 (BioChaperone® Lispro) Phase 3 Data in Type 2 Diabetes Presented at ADA 86th Scientific Sessions, Confirming the Positive Results Previously Announced in July 2025 adocia.com ↗ |
| 2026-06-08 | Diasome Pharmaceuticals | Results Medscape Covers Diasome's OPTI-2 Liver-Directed Insulin Data from ADA 2026 diasome.com ↗
New Phase 2b data presented at ADA 2026 suggest that Diasome's investigational liver-directed insulin may reduce the risk of hypoglycemia in people with type 1 diabetes. |
| 2026-06-07 | Diasome Pharmaceuticals | Results Diasome Presents Phase 2b Data Demonstrating HDV™-Insulin Lispro Maintains Glycemic Control While Reducing Hypoglycemia in Adults with Type 1 Diabetes diasome.com ↗
In an oral presentation today at the American Diabetes Association (ADA) 86th Scientific Sessions, Diasome reported that HDV-LIS maintained glycemic control with an A1C non-inferiority margin of <0.1% met at Weeks 12 and 25. |
| 2026-06-05 | Mannkind Corporation | Results Data at ADA 2026 Highlights Key Findings from Clinical and Real‑World Studies of MannKind’s Afrezza® (Inhaled Insulin) Across Pediatric Care, Pregnancy, and Use with Automated Insulin Delivery (AID) Systems mannkindcorp.com ↗
A new analysis of euglycemic clamp data comparing inhaled insulin to insulin lispro showed that inhaled insulin delivers a substantially greater proportion of its pharmacodynamic effect earlier with over 50% within 60 minutes versus 10% for lispro. |
| 2026-06-01 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Receives Another Brazilian GMP Certification, Achieving Dual Compliance for Drug Substances and Finished Products ganlee.com ↗
The certification covers two core finished products, insulin aspart and insulin lispro, and was granted to its subsidiary, Gan & Lee Pharmaceuticals of Brazil Commercial and Importer for Medicines Ltda. |
| 2026-05-15 | Sandoz | Regulatory Sandoz confirms European Commission approval for biosimilars Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), strengthening position in diabetes sandoz.com ↗
Basel, 15 May 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda (insulin aspart). |
| 2026-05-15 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Receives European Commission Approval for Bysumlog® (Insulin Lispro) and Dazparda® (Insulin Aspart), Expanding Its Presence in Europe ganlee.com ↗
Gan & Lee Pharmaceuticals has now obtained EC marketing authorization for two rapid-acting insulin products: insulin lispro injection (EU brand name: Bysumlog ® ) and insulin aspart injection (EU brand name: Dazparda ® ). |
| 2026-04-09 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Receives Brazilian GMP Certification for Insulin Aspart and Insulin Lispro Drug Substances ganlee.com ↗
The successful passing of this inspection signifies that the production quality systems for Gan & Lee's insulin aspart and insulin lispro drug substances fully comply with Brazilian regulatory standards. |
| 2026-02-26 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals' Bysumlog® and Dazparda® Receive Positive CHMP Opinion, Potentially Paving the Way For More Treatment Options for European Patients with Diabetes ganlee.com ↗
Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) and its European subsidiary Gan & Lee Pharmaceuticals Europe GmbH announced that Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of a marketing authorisation for its biosimilar insulin lispro injection (EU brand name: Bysumlog ® ; China brand name: Prandilin ®1 ) for the treatment of diabetes mellitus in adults and children, and insulin aspart injection (EU brand name: Dazparda ® ; China brand name: Rapilin ® 2 ) for the treatment of diabetes mellitus in adults, adolescents, and children aged 1 year and older. |
| 2025-10-15 | Adocia | Results ADOCIA and Tonghua Dongbao Announce Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone® Lispro (THDB0206 injection) in people with T1D adocia.com ↗
ADOCIA and Tonghua Dongbao Announce Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone® Lispro (THDB0206 injection) in people with T1D |
| 2025-07-25 | Adocia | Results ADOCIA and Tonghua Dongbao Announce Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone® Lispro (THDB0206 injection) in people with T2D adocia.com ↗
Adocia (Euronext Paris: FR0011184241 – ADOC, the “Company”), a clinical -stage biopharmaceutical company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and obesity , announces that its partner Tonghua Dongbao releases today positive topline results on the Phase 3 clinical trial on BioChaperone® Lispro (THDB0206 injection), a novel Ultra-Rapid Insulin formulation. |
| 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. |
| 2023-10-09 | Gan and Lee Pharmaceuticals, USA | Regulatory The Scientific Evaluation from EMA on Marketing Authorisation Application of Gan & Lee Insulin Lispro biosimilar Starts upon the Positive Validation Letter ganlee.com ↗
Beijing, China/Duesseldorf, Germany, Oct. 09, 2023 —Gan & Lee Pharmaceuticals Europe GmbH， a wholly-owned subsidiary of Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee" , stock code: 603087. SH) submitted the Marketing Authorization Application (hereinafter referred to as "MAA") of Insulin lispro biosimilar to the European Medicines Agency (hereinafter referred to as "EMA"), and recently received the Positive validation letter (formal acceptance notice)from the EMA, entering the review stage. |
| 2023-06-01 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals on the official acceptance of the application for listing license of proposed biosimilar insulin lispro injection by the US FDA ganlee.com ↗
It is more exciting news that the BLA submission of Gan & Lee proposed biosimilar Insulin Lispro subcutaneous Injection was accepted for filing by the US FDA after that of Gan & Lee proposed biosimilar Insulin Glargine Injection. |
| 2022-10-06 | Adocia | Results ADOCIA Announces Exceptional Weight Loss for Obese People with Type 1 Diabetes using M1Pram in a post-hoc analysis adocia.com ↗
Glycemic control efficacy comparable to that obtained with the commercial reference insulin Humalog® (Eli Lilly) |
| 2022-06-21 | Adocia | Results ADOCIA announces M1Pram Phase 2 Trial Meets Primary Objective by Reducing Weight in Overweight People with Type 1 Diabetes adocia.com ↗ |
| 2022-04-11 | Adocia | Regulatory ADOCIA Announces Start of 3 Clinical Studies for BioChaperone® Combo with Partner Tonghua Dongbao adocia.com ↗ |
| 2021-10-14 | Adocia | Regulatory ADOCIA’s partner Tonghua Dongbao Receives Clearance to Start Ultra-Rapid Insulin BioChaperone® Lispro Phase 3 Trial in China adocia.com ↗ |
| 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 lispro (GL-LIS) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin lispro. |
| 2021-08-16 | Eli Lilly and Company | Regulatory FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved an expanded label for Eli Lilly and Company's (NYSE: LLY) rapid-acting insulin, Lyumjev® (insulin lispro-aabc injection) 100 units/mL indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. |
| 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. |
| 2021-01-25 | Adocia | Results Adocia Announces Positive Clinical Results Confirming the Ultra-Rapid Profile of a BioChaperone® Lispro Formulation Containing Insulin from Partner Tonghua Dongbao adocia.com ↗
In this study, the BioChaperone Lispro formulation containing insulin lispro from Tonghua Dongbao demonstrated similar ultra -rapid pharmacokinetic, pharmacodynamic, and safety profiles when compared to a BioChaperone Lispro formulation containing insulin lispro Humalog® |
| 2020-01-31 | Eli Lilly and Company | Regulatory CHMP Recommends Approval of Lilly's New Fast-Acting Mealtime Insulin to Improve Glycemic Control in Adults with Diabetes lilly.com ↗
This is the first regulatory step toward approval for this new insulin in Europe. |
| 2019-06-09 | Eli Lilly and Company | Results Lilly's ultra rapid lispro provided similar A1C reductions compared to Humalog® (insulin lispro), with superior post-meal blood glucose reductions lilly.com ↗
Two phase 3 studies show that Eli Lilly and Company's (NYSE: LLY) ultra rapid lispro (URLi) provided non-inferior A1C reductions compared to Humalog® (insulin lispro) at 26 weeks in people with type 1 and type 2 diabetes. |
| 2019-02-12 | Adocia | Results Adocia to Present New Clinical Data on BioChaperone® Technology at ATTD 2019 adocia.com ↗
The Ultra-Rapid Insulin BioChaperone Lispro Bolused By Insulin Pump Shows Favourable Pharmacodynamics And Pharmacokinetics vs. Faster Aspart and Insulin Aspart |
| 2018-10-02 | Eli Lilly and Company | Results Results from Two Phase 3 Studies Show Lilly's Ultra Rapid Lispro (URLi) Met Primary Efficacy Endpoint in People with Type 1 and Type 2 Diabetes lilly.com ↗
The primary efficacy endpoint of non-inferiority to Humalog, as measured by A1C reduction from baseline, was met in both studies at 26 weeks. |
| 2018-09-26 | Adocia | Results Adocia to Present Five Abstracts at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD) adocia.com ↗
The ultra-rapid insulin BioChaperone Lispro shows favourable pharmacodynamics and pharmacokinetics compared to faster insulin aspart and insulin aspart in insulin pumps |
| 2018-09-05 | Adocia | Results Adocia announces positive topline results for the first clinical study of BioChaperone® Pramlintide Insulin in people with type 1 diabetes adocia.com ↗
BC Pram Ins showed a significant 97% decrease in blood glucose excursion over the first two hours after the meal compared to Humalog® |
| 2018-06-23 | Eli Lilly and Company | Results New Data Presented at the American Diabetes Association 78th Scientific Sessions® Reinforce Potential of Lilly's Ultra Rapid Lispro in People with Type 1 and Type 2 Diabetes lilly.com ↗
Across all three studies, URLi was absorbed faster than Humalog, which led to improved post-meal blood sugar control that was sustained over time. |
| 2018-06-14 | Adocia | Results Adocia to Present Six Abstracts at the American Diabetes Association® 78th Scientific Sessions adocia.com ↗
The Ultra-Rapid Insulin (URI) BioChaperone® Lispro (BCLIS) shows Favorable Pharmacodynamics (PD) and Pharmacokinetics (PK) vs Faster Aspart (FIA) and Insulin Aspart (ASP) in Insulin Pumps (CSII) |
| 2017-12-06 | Adocia | Results Adocia announces positive topline study results comparing ultra-rapid insulin BioChaperone® Lispro with Novolog® and Fiasp® in people with type 1 diabetes adocia.com ↗
Adocia (Euronext Paris: FR0011184241- ADOC), the clinical biopharmaceutical company focused on developing innovative formulations of approved proteins for the treatment of diabetes, announced today positive topline results of a clinical study evaluating BioChaperone® Lispro, an ultra-rapid formulation of insulin lispro, compared to Novolog® (insulin aspart, Novo Nordisk), a rapid-acting insulin analog, and Fiasp® (faster-acting insulin aspart, Novo Nordisk), the only EMA -approved (Europe an Medical Agency) and FDA-approved (Federal Drug Administration, USA ) “ultra-rapid acting” insulin formulation. |
| 2017-10-30 | Mannkind Corporation | Results Type 1 Diabetes Patients Using AFREZZA Have More Positive View of Therapy Compared to Standard Insulin Therapy mannkindcorp.com ↗
Perceptions of insulin therapy, (overall and three subscales: convenience, comfort, and ease of regimen adherence) improved from baseline to Week 16 in the TI Inhalation Powder group (all p<0.01), and comfort improved in the insulin lispro group (p<0.05). |
| 2017-10-30 | Mannkind Corporation | Results Study Shows AFRESA(R) Provides Rapid Suppression of Endogenous Glucose Production in Diabetes Patients mannkindcorp.com ↗
Results from the open-label, single-dose, three-way crossover study showed that endogenous glucose production (EGP) was suppressed earlier following AFRESA administration compared with subcutaneous insulin lispro and inhaled Exubera in adult patients with type 2 diabetes. |
| 2017-10-30 | Mannkind Corporation | Results MannKind Announces Late-Breaking Data Demonstrating Faster Onset and Shorter Duration of Action Compared to Mealtime Insulins mannkindcorp.com ↗
Data presented at ADA show Afrezza has a 25-to 35-minute faster onset of action than Lispro, with a duration that is up to two hours shorter |
| 2017-10-30 | Mannkind Corporation | Results AFREZZA(R) Suppresses Endogenous Glucose Production More Rapidly Than Currently Available Insulin Therapy mannkindcorp.com ↗
The highest FFA AOC was observed after AFREZZA 90U, while lispro and 60U AFREZZA were comparable. |
| 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 study showed that BioChaperone Lispro improved post-prandial glycemic control compared to insulin lispro (Humalog®, Eli Lilly) when repeatedly administered to people with type 1 diabetes for 14 days. |
| 2017-06-13 | Eli Lilly and Company | Regulatory U.S. FDA Approves Humalog® Junior KwikPen® for the Treatment of Diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s (NYSE: LLY) Humalog® Junior KwikPen® for the treatment of diabetes. |
| 2017-05-30 | Adocia | Results Adocia Announces Six Data Presentations at the American Diabetes Association® 77th Scientific Sessions adocia.com ↗
Ultra-rapid BioChaperone Lispro (BCLIS) Improves Postprandial Blood Glucose (PPG) Excursions vs. Insulin Lispro (LIS) in a 14-Day Treatment Study in Subjects with Type 1 Diabetes (T1DM) |
| 2016-12-16 | Adocia | Results Adocia and Lilly announce successful completion of an insulin pump study with BioChaperone Lispro adocia.com ↗
BioChaperone Lispro U100 demonstrated a statistically significant increase in insulin exposure over the first 30 minutes after a mealtime bolus compared to Humalog |
| 2016-10-27 | Adocia | Results Adocia Announces Positive Topline Results from a Phase 1b Clinical Trial Measuring the Post-Meal Effect of Rapid-Acting Human Insulin, HinsBet® U100 adocia.com ↗
HinsBet also show ed a similar effect to that of Humalog® on postprandial blood glucose control over the first hour post-meal |
| 2016-09-08 | Adocia | Results Adocia to Present Clinical Data Validating BioChaperone® Technology at the 2016 EASD Annual Meeting adocia.com ↗
Lead Scientist and Chairman of Profil Germany, Dr. Tim Heise, will present findings that demonstrate superior postprandial blood glucose control in patients with type 1 diabetes using ultra -rapid BioChaperone® Lispro vs. Humalog®. |
| 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 ↗
Lead Scientist and Chairman of Profil Germany, Doctor Tim Heise, will present findings demonstrating superior postprandial blood glucose control in patients with type 1 diabetes using ultra-rapid BioChaperone® Lispro vs. Humalog®. |
| 2016-05-31 | Adocia | Results Adocia and Lilly announce positive topline results from a Phase 1 study evaluating ultra-rapid insulin BioChaperone Lispro U100 in healthy Japanese subjects adocia.com ↗ |
| 2016-04-27 | Adocia | Results Adocia and Lilly announce positive topline results from a Phase 1b study of repeated administration of ultra-rapid BioChaperone Lispro U100 in people with type 2 diabetes adocia.com ↗ |
| 2016-03-14 | Adocia | Results Adocia and Lilly announce positive topline results from a Phase 1b study of repeated administration of ultra-rapid BioChaperone Lispro in patients with type 1 diabetes adocia.com ↗ |
| 2015-12-11 | Adocia | Results Adocia and Lilly report positive results of a pilot bioequivalence study comparing BioChaperone Lispro U200 to BioChaperone Lispro U100 adocia.com ↗ |
| 2015-06-26 | Adocia | Results Adocia and Lilly report positive Phase 1b topline results on the post-meal effect of ultra-rapid BioChaperone Lispro in patients with type 1 diabetes adocia.com ↗
Adocia and Lilly report positive Phase 1b topline results on the post-meal effect of ultra-rapid BioChaperone Lispro in patients with type 1 diabetes |
| 2015-05-27 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration Approves Humalog® 200 units/mL KwikPen® lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2014-09-09 | Adocia | Results Adocia Reports Positive Preliminary Results from Dose Response Clinical Study of Ultra-fast acting BioChaperone® Lispro U100 in Patients with Type 1 Diabetes adocia.com ↗
This dose response study confirms that BioChaperone Lispro U100 more closely mimics the endogenous insulin secretion observed in healthy individuals in response to a meal than Humalog, at all tested doses. |
| 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 ↗
Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7 percent, and patients treated with the dulaglutide-mealtime insulin lispro combination had 30 percent less total insulin dose. |
| 2014-06-10 | Adocia | Results Adocia Announces Positive Preclinical Results for a Concentrated Ultra-Fast insulin, BioChaperone® Lispro U300 adocia.com ↗ |
| 2014-04-10 | Adocia | Results Adocia: Ultra Fast Lispro Clinical Results adocia.com ↗
The present study met its primary endpoint, showing a significant increase in BioChaperone Lispro bioavailability in the first half-hour compared to Humalog. |
| 2014-03-17 | Adocia | Results Adocia: confirmation of positive clinical results Combo adocia.com ↗ |
| 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 in combination with insulin lispro demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine in combination with insulin lispro at 26 weeks (AWARD-4). |
| 2012-06-11 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Formulations Improved Postprandial Glycemic Control in Patients Living with Type 1 Diabetes: Phase 2 Study Results Presented at ADA 2012 halozyme.com ↗
The study met its primary endpoint of A1C non-inferiority (A1C is a measure of average blood sugar over three months). |
| 2012-06-09 | GlaxoSmithKline | Results GSK announces new 52-week data from phase III study of once-weekly albiglutide in type 2 diabetes gsk.com ↗
Detailed findings from a Phase III study comparing the investigational glucagon-like peptide-1 (GLP-1) receptor agonist albiglutide to prandial insulin (Lispro), were presented today at the American Diabetes Association Meeting (ADA) in Philadelphia, USA, and show that the effect is maintained out to 52 weeks. |
| 2012-06-09 | Halozyme Therapeutics | Results Halozyme Presents Positive Data from Two Ultrafast Insulin Clinical Trials with Human Hyaluronidase Enzyme - rHuPH20 - at ADA 2012 halozyme.com ↗
The study met the primary endpoint of showing that the Analog-PH20 formulations were non-inferior for A1C compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.12, +.05). |
| 2012-04-03 | GlaxoSmithKline | Results GSK receives further data from phase lll studies of albiglutide in type 2 diabetes gsk.com ↗
In this study, the first of its kind for the class, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus preprandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint. |
| 2011-10-21 | Halozyme Therapeutics | Results Halozyme Announces Positive Results From Phase 2 Ultrafast Insulin Trials in Patients with Type 1 and Type 2 Diabetes halozyme.com ↗
Both trials met the primary endpoint of non-inferiority of HbA1C compared to the insulin analog comparator, with superior reductions in post-prandial glucose excursions in the PH20 insulin analog arms. |
| 2011-06-08 | Eli Lilly and Company | Regulatory FDA Approves Updates to Lilly's Humalog® (insulin lispro injection [rDNA origin]) Label lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental new drug application (sNDA) with the following updates to the Humalog label: continuous insulin infusion pump therapy in children 4 years of age and over with type 1 diabetes extension of the time-in-use in the external pump reservoir to a maximum of seven days; and extension of the time-in-use of the infusion set and of the infusion set subcutaneous insertion site to a maximum of three days. |
| 2010-11-12 | Halozyme Therapeutics | Results Halozyme's rHuPH20 With Recombinant Human Insulin Demonstrates Glycemic Control Comparable to Lispro halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced Phase 2 results demonstrating that Insulin-PH20 (recombinant human insulin with rHuPH20) produced glycemic control comparable to lispro, a widely prescribed prandial (mealtime) insulin analog. |
| 2010-06-28 | Halozyme Therapeutics | Results Coinjection of Halozyme's rHuPH20 Enzyme Accelerates the Absorption and Action of Mealtime Insulin Analogs halozyme.com ↗
The coinjection of PH20 with lispro (Humalog(R)), aspart (NovoLog(R)) and glulisine (Apidra(R)) results in a more physiologic fast-in, fast-out profile and enhances the glucodynamic performance for each analog. |
| 2010-06-27 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Accelerates Absorption and Lowers Hyperglycemia and Hypoglycemia Risk in Type 2 Diabetes Patients halozyme.com ↗
Significantly more patients receiving lispro+PH20, 71% versus 48%, achieved the American Diabetes Association (ADA) goal of maintaining glucose below 180 mg/dL compared to lispro treatment alone, an indication of reduced hyperglycemia. |
| 2009-11-06 | Halozyme Therapeutics | Results Halozyme Study Results Demonstrate Significantly Less Absorption Variability for Insulin Lispro Administered with PH20 Enzyme halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced insulin variability study results that demonstrated reduced intrasubject absorption variability for the combination of lispro, a meal time analog insulin, plus PH20 (hyaluronidase) compared to subcutaneous injection of lispro alone. |
| 2009-10-21 | Halozyme Therapeutics | Results Halozyme Study Results Show Faster Insulin Absorption when Administered in Combination with a Wide Range of PH20 Enzyme Concentrations halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced dose response study results that demonstrated faster insulin absorption and increased peak insulin concentrations after co-administration of its recombinant hyaluronidase enzyme (rHuPH20 or PH20) with regular human insulin and with insulin lispro. |
| 2009-06-06 | Halozyme Therapeutics | Results Halozyme's Phase 2 Insulin-PH20 Study Demonstrates Faster Insulin Absorption and Superior Glucose Control in Type 1 Diabetic Patients halozyme.com ↗
Study results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal, with improvements in both peak glycemic response and total hyperglycemic exposure compared to Humalog alone. |
| 2009-05-29 | Halozyme Therapeutics | Results Phase 1 Study for Halozyme's Insulin-PH20 Published, Highlights Findings for Faster Acting Insulin Formulations halozyme.com ↗
“The faster onset and faster offset of glucose effects for insulin plus PH20 observed in this study may lead to a superior treatment for diabetes,” stated Douglas B. Muchmore, M.D., vice president, endocrinology clinical development at Halozyme. |
| 2008-06-09 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability halozyme.com ↗
Significantly faster systemic absorption of each insulin, starting with the first observation time point of three minutes after injection |
| 2005-09-12 | Eli Lilly and Company | Results Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin lilly.com ↗
In addition, 80 percent of patients in this study expressed a preference for the Lilly/Alkermes inhaled insulin system at mealtime over injected insulin. |
| 2005-09-12 | Alkermes, Inc. | Results Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin; 80 Percent of Diabetes Patients in Study Preferred Inhaled Insulin System to Mealtime Injections alkermes.com ↗
Researchers also presented results from a Phase 1 dose response and equivalence study, which showed that the Lilly/Alkermes inhaled insulin system and injected insulin lispro were generally well-tolerated and the overall effect on blood sugar was similar, illustrating that doses could be reliably correlated. |
| 2005-06-14 | Eli Lilly and Company | Results Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin lilly.com ↗
the Lilly/Alkermes inhaled insulin system and injected insulin lispro were generally well-tolerated and the overall effect on blood sugar was similar |
| 2005-06-14 | Alkermes, Inc. | Results Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin alkermes.com ↗
Researchers also presented results from a Phase 1 dose response and equivalence study, which showed that the Lilly/Alkermes inhaled insulin system and injected insulin lispro were generally well-tolerated and the overall effect on blood sugar was similar, illustrating that doses could be reliably correlated. |
| 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. |
| 2001-06-25 | Alkermes, Inc. | Results Alkermes Presents Results of Pulmonary Insulin Clinical Trial At Annual Meeting of the American Diabetes Association alkermes.com ↗
AI showed a faster onset of action compared with s.c. insulin (early Tmax 50%(min): 29 (84 IU), 35 (168 IU), 33 (294 IU), 41 (IL) and 70 (RI) (p0.01 for AI (all doses) vs. RI)). |
All press releases naming this drug 105 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 105 releases opens the full record — a long page | ||
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 291 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Insulin Lispro | “The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin...” NCT00447213 ↗191“Comparison of 2-Hour Postprandial Blood Glucose Excursion in Response to a Standard Test Meal in Insulin-Requiring Diabetic Patients Treated Twice Daily With Either Insulin...” NCT00191581 ↗ “Patients originally receiving insulin glargine were enrolled in intensification arm A and were randomized to receive BBT (insulin glargine once daily plus mealtime insulin...” PMID 20685497 ↗ May 2010 “Types of insulin: insulin lispro (Humalog 100 IU/mL) as fast-acting insulin and regular insulin (Humulin R) as regular insulin (Eli Lilly and Company, Indianapolis, IN, USA).” NCT04783376 ↗ “Patients were randomized to a two-period crossover study schedule, ingesting breakfast, with or without insulin lispro (to induce low or high postprandial glycemia).” PMID 26731258 ↗ Jan 2016 “Commercially available U-200 Humalog (insulin lispro) diluted 1:1 with a dilution buffer composed of sterile water, EDTA and mannitol to achieve U-100 concentration.” NCT07090824 ↗ “In this context, we sought to evaluate the vascular function effects of adding the GLP1-RA exenatide or meal insulin lispro to basal glargine therapy in early T2DM.” PMID 36894921 ↗ Mar 2023 “Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.” NCT03463564 ↗ “Administer subcutaneous regular human insulin 30 to 60 minutes before meals, or administer insulin lispro within 15 minutes before meals.” NCT00063128 ↗ “Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening.” NCT02688933 ↗ “Individualized dose of RAA injection (insulin aspart, insulin lispro or insulin glulisine) for each patient for 26 weeks.” NCT04974528 ↗ |
| Known as | BioChaperone insulin lispro | “Single subcutaneous administration of BioChaperone® insulin lispro” NCT03179332 ↗ |
| Known as | GL-Lis | “lispro (GL-Lis, n = 38)” PMID 37735841 ↗ Sep 2023 |
| Known as | HDV-bound LIS | “The name of the investigational drug is Hepatic Directed Vesicles + Insulin Lispro (HDV-bound LIS).” NCT05689424 ↗ |
| Known as | Hepatic Directed Vesicles + Insulin Lispro | “The name of the investigational drug is Hepatic Directed Vesicles + Insulin Lispro (HDV-bound LIS).” NCT05689424 ↗ |
| Known as | Hlog | “The aim of this multicenter, prospective, randomized, crossover trial is to compare, in critical care patients receiving insulin infusion therapy (IIT), the pharmacodynamic of...” PMID 25466315 ↗ Oct 2014 |
| Known as | Humalog | “This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2...” NCT02562326 ↗62“This study is designed to compare the safety and tolerability of two different doses of intranasally administered regular human insulin with those of a single dose of the...” NCT01201278 ↗ “In order to match peripheral lispro concentrations between study visits, a small dose of Humalog (lispro) insulin will be administered intravenously at 9am, during the placebo...” NCT02131948 ↗ “This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.” NCT00097071 ↗ “Commercially available U-200 Humalog (insulin lispro) diluted 1:1 with a dilution buffer composed of sterile water, EDTA and mannitol to achieve U-100 concentration.” NCT07090824 ↗ “Participants can take very short acting insulin (e.g. Humalog or Novolog) up to 2 hours before the test if necessary and then that will be withheld during the test.” NCT01269047 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).” NCT02798250 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846831 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02490098 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846857 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02626936 ↗ |
| Known as | Humalog (lispro) | “Humalog (lispro)” NCT01378117 ↗ |
| Known as | Humalog 100 IU/mL | “Types of insulin: insulin lispro (Humalog 100 IU/mL) as fast-acting insulin and regular insulin (Humulin R) as regular insulin (Eli Lilly and Company, Indianapolis, IN, USA).” NCT04783376 ↗ |
| Known as | Humalog insulin | “Humalog insulin” NCT01149005 ↗ |
| Known as | Humalog insulin lispro U-100 | “Humalog insulin lispro U-100” NCT02500979 ↗ |
| Known as | Humalog U-100 | “Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection” NCT03307512 ↗ |
| Known as | ILPS | “Drug: Insulin Lispro Protamine Suspension (ILPS)” NCT00666718 ↗ |
| Known as | Insulin Lispro Protamine Suspension | “OBJECTIVE: To determine whether metformin-treated patients with type 2 diabetes given an analogue mixture of basal and rapid-acting insulins (insulin lispro protamine...” PMID 19454394 ↗ May 20097“Insulin lispro protamine suspension (Humalog® NPL, Eli Lilly), 100 U/mL in 3 mL cartridges” NCT00810589 ↗ “lispro mix 50/50: 50% insulin lispro protamine suspension and 50% lispro” PMID 17934150 ↗ Oct 2007 |
| Known as | Insulin Lispro Protamine Suspension (ILPS) | “Insulin Lispro Protamine Suspension (ILPS)” NCT00510952 ↗ |
| Known as | LIS | “BACKGROUND: This study was performed to satisfy a US Food and Drug Administration post-marketing requirement to compare the dose responses for Technosphere® Insulin (TI;...” PMID 34773608 ↗ Nov 20211“6 U insulin lispro (LIS) sc on a separate visit” NCT02713841 ↗ |
| Known as | lispro | “In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro” PMID 36894921 ↗ Mar 202344“Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed” NCT01845831 ↗ “Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG \>140 mg/dl.” NCT04416269 ↗ “This study compared the pharmacokinetic and glucodynamic parameters of URLi and Lispro (Humalog®) at 3 dose levels in healthy subjects.” PMID 32900535 ↗ Sep 2020 “The short acting insulin analogue (lispro, aspart or glulisine) will be started at the dosage of 4 units before meals (3 times per day)” NCT04196231 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).” NCT02798250 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02488616 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02626936 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846831 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846857 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02490098 ↗ |
| Known as | Lispro Insulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01045954 ↗ |
| Known as | Lispro Prandial Insulin | “Drug: Lispro Prandial Insulin” NCT06280703 ↗ |
| Known as | LM50 | “AIM: To compare the 2-h postprandial blood glucose (PPBG) excursion following a standard test meal in insulin-requiring patients with diabetes treated twice daily with human...” PMID 18657196 ↗ Jul 2008 |
| Known as | Ly-Lis | “BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog®; Ly-Lis).” PMID 29232162 ↗ Dec 2017 |
| Known as | LY900014 | “This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar.” NCT03232983 ↗ |
| Known as | prandilin | “lispro (prandilin®)” PMID 37735841 ↗ Sep 2023 |
| Known as | URLi | “Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control.” PMID 34041713 ↗ May 20211“Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control.” PMID 35577602 ↗ May 2022 |
| Modality | Protein / enzyme biologic | “fast acting insulin (Lispro)” NCT00046501 ↗ |
| Route | Subcutaneous | “preprandial SC insulin (regular human insulin or insulin lispro)” PMID 17288697 ↗ Feb 2007 |