Drugs / insulin aspart
insulin aspart
also known as
NovoRapid · IAsp · aspart · NovoLog · Fiasp · aspart insulin · Faster-acting insulin aspart · Fast-acting insulin aspart · +29 more
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diabetes mellitus 1 milestone | |||||
| Filed | Other | ASPARAPID | diabetes mellitus | 2024-10-16 | “Wockhardt files fast-acting Insulin Aspart injection (ASPARAPIDTM) with DCGI; strengthens commitment to diabetes management” wockhardt.com ↗ |
| Filed diabetes mellitus, congenital autoimmune 4 milestones | |||||
| Filed | US (FDA) | — | diabetes mellitus, congenital autoimmune | 2017-03-29 | “resubmitted the new drug application (NDA) for fast-acting insulin aspart as a class II re-submission to the US Food and Drug Administration (FDA).” novonordisk.com ↗ |
| Rejected (CRL) | US (FDA) | — | diabetes mellitus, congenital autoimmune | 2016-10-07 | “received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Application for faster-acting insulin aspart.” novonordisk.com ↗ |
| Filed | US (FDA) | — | diabetes mellitus, congenital autoimmune | 2015-12-09 | “today announced the submission of the New Drug Application (NDA) for faster-acting insulin aspart to the US Food and Drug Administration (FDA).” novonordisk.com ↗ |
| Filed | EU (EMA) | — | diabetes mellitus, congenital autoimmune | 2015-12-04 | “today announced the submission to the European Medicines Agency of the Marketing Authorisation Application (MAA) for the approval of faster-acting insulin aspart.” novonordisk.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Filed | EU (EMA) | — | — | 2023-10-09 | “submitted the Marketing Authorization Application (hereinafter referred to as "MAA") of Insulin aspart biosimilar to the European Medicines Agency” ganlee.com ↗ |
| Label expansions (2) | US (FDA) | FIASP PENFILL | — | 2019-10-21 – 2019-12-19 | fda.gov ↗ |
| Label expansions (6) | US (FDA) | NOVOLOG PENFILL | — | 2001-12-21 – 2015-01-14 | fda.gov ↗ |
| Approved | US (FDA) | NOVOLOG PENFILL | — | 2000-06-07 | fda.gov ↗ |
| Approved | EU (EMA) | NovoRapid | — | 1999-09-07 | europa.eu ↗ |
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US approved 2000
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06547619 | Oct 2024 → May 2026 overdue | gestational diabetes | Anna Stanhewicz, PhD | Recruiting | No outcome recorded |
| Phase 0 | NCT05946798 | Aug 2023 → Jun 2027 expected | gestational diabetes | Anna Stanhewicz, PhD | Recruiting | No outcome recorded |
| Phase 0 | NCT05946785 | Jul 2023 → Dec 2026 expected | gestational diabetes | Anna Stanhewicz, PhD | Recruiting | No outcome recorded |
| Phase 0 | NCT03666065 | Jan 2020 → Jun 2023 | type 1 diabetes mellitus | Yale University | Completed | No outcome recorded |
| Phase 139 trials · 2 met primary | ||||||
| Phase 1 | NCT07068295 | Jul 2025 → Feb 2026 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT06809621 | Jan → Jul 2025 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT06375031 | May → Jul 2024 | diabetes mellitus | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05737576 | Mar → Oct 2023 | diabetes mellitus | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05754424 | Feb 2023 → Jan 2024 | type 2 diabetes mellitus | Arecor Limited | Completed | No outcome recorded |
| Phase 1 | NCT05184868 | Jan → Sep 2022 | type 1 diabetes mellitus | Arecor Limited | Completed | No outcome recorded |
| Phase 1 | NCT04660305 | Dec 2020 → Jun 2021 | type 1 diabetes mellitus | Arecor Limited | Completed | No outcome recorded |
| Phase 1 | NCT04237129 | Aug → Dec 2019 | type 1 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | Met primary |
| Phase 1 | NCT03959514 | Apr → Jul 2019 | type 1 diabetes mellitus | Arecor Limited | Completed | No outcome recorded |
| Phase 1 | NCT03436498 | May → Oct 2018 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03407599 | Jan → Jul 2018 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03215498 | Jul → Nov 2017 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02594033 | Oct 2015 → Jan 2016 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02462161 | Mar 2015 → Apr 2019 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02089451 | Mar → Jun 2014 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01992588 | Nov 2013 → Mar 2014 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01934712 | Aug 2013 → Jan 2014 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01773798 | Jan → Aug 2013 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01590836 | Apr → Jun 2012 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01399346 | Apr → Jun 2011 | type 1 diabetes mellitus | Medical University of Graz | Completed | No outcome recorded |
| Phase 1 | NCT01269606 | Jan → Mar 2011 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01173926 | Jul → Nov 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01121276 | Apr → Sep 2010 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00979875 | Sep 2009 → Feb 2010 | — | Halozyme Therapeutics | Completed | Met primary |
| Phase 1 | NCT01868568 | Apr → Aug 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01159353 | Sep 2007 → Apr 2008 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01865305 | Sep 2006 → Feb 2007 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01536028 | Apr → Jul 2006 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00115973 | Jun 2005 → Jan 2006 | type 2 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 | NCT01620450 | Nov 2004 → Feb 2005 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01486914 | Jan → Feb 2003 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01698697 | Sep → Oct 2002 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00513643 | Apr → Jun 2002 | diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01526941 | May → Jul 2001 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01620424 | Feb → Apr 2001 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01620333 | Feb → Apr 2000 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01523041 | Nov 1999 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01707160 | Nov → Dec 1995 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00581867 | Oct 2007 → May 2012 | Alzheimer disease | Jeff Burns, MD | Completed | No outcome recorded |
| Phase 1/2 | NCT00353990 | Aug → Dec 2006 | diabetes mellitus | University of Aarhus | Completed | No outcome recorded |
| Phase 29 trials · 2 met primary · 1 missed | ||||||
| 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 | NCT03800875 | Feb 2019 → Sep 2020 | type 1 diabetes mellitus | McGill University | Completed | Missed primary |
| Phase 2 | NCT04292535 | Jun 2018 → Feb 2020 | — | Michigan State University | Completed | No outcome recorded |
| Phase 2 | NCT01561378 | Aug 2012 → Oct 2014 | delirium, subjective cognitive decline | Albert Einstein College of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01756105 | Jun 2012 → Feb 2018 | gestational diabetes | University Hospital, Strasbourg, France | Terminated | No outcome recorded |
| Phase 2 | NCT01510093 | May → Dec 2012 | type 2 diabetes mellitus | Aarhus University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01194245 | Aug 2010 → Aug 2011 | type 1 diabetes mellitus | Halozyme Therapeutics | Completed | Met primary |
| Phase 2 | NCT01194258 | Aug 2010 → Aug 2011 | type 2 diabetes mellitus | Halozyme Therapeutics | 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 2/33 trials | ||||||
| Phase 2/3 | NCT03262116 | Mar → Jul 2019 | type 1 diabetes mellitus | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 2/3 | NCT03565666 | Jul → Nov 2018 | type 1 diabetes mellitus | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT02496780 | Aug 2015 → Jul 2022 | cystic fibrosis | University of Minnesota | Terminated | No outcome recorded |
| Phase 331 trials · 8 met primary · 2 missed | ||||||
| Phase 3 | NCT05802862 | Jul 2023 → Aug 2024 | diabetes mellitus | Sunshine Lake Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05641337 | Oct 2022 → Dec 2025 | cirrhosis of liver, diabetes mellitus | Huashan Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03977727 | Jun 2019 → Mar 2020 | type 1 diabetes mellitus | Texas Diabetes & Endocrinology, P.A. | Completed | Met primary |
| Phase 3 | NCT04079413 | Jun 2019 → Jan 2020 | type 1 diabetes mellitus | Geropharm | Completed | No outcome recorded |
| Phase 3 | NCT03874715 | Mar 2019 → Jul 2020 | type 1 diabetes mellitus | Sanofi | Completed | Mixed |
| Phase 3 | NCT02500706 | May 2016 → Jul 2017 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT02546401 | Sep 2015 → Mar 2016 | type 1 diabetes mellitus | University Hospital, Brest | Completed | Met primary |
| Phase 3 | NCT02491528 | Jun 2015 → Aug 2016 | diabetes mellitus | Tonghua Dongbao Pharmaceutical Co.,Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01819129 | Sep 2013 → Jan 2015 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT01814137 | Mar 2013 → Mar 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01713530 | Feb 2013 → Jan 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 3 | NCT01388361 | Sep 2011 → Jul 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00888732 | Jun 2009 → Jun 2010 | type 1 diabetes mellitus | University of Aarhus | Completed | No outcome recorded |
| Phase 3 | NCT00267683 | Dec 2005 → Apr 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00151697 | May 2005 → ? | type 2 diabetes mellitus | Rijnstate Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00097877 | Jan 2005 → Nov 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00097071 | Oct 2004 → May 2006 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00500240 | Apr 2004 → Apr 2012 | acute leukemia, lymphoma | M.D. Anderson Cancer Center | Terminated | Missed primary |
| Phase 3 | NCT00600626 | Jan → Jul 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00605020 | Dec 2003 → Mar 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00604656 | May 2003 → Jan 2004 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00725036 | Sep 2002 → Dec 2004 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00071448 | Jun 2002 → Jun 2004 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01486940 | Mar → Oct 2002 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01650129 | Dec 2000 → Oct 2001 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00065130 | Apr 2000 → Dec 2003 | gestational diabetes | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01520818 | Mar 2000 → Apr 2001 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00832182 | Dec 1999 → Nov 2002 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01520753 | Mar → Jun 1999 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01467323 | Apr → Sep 1998 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01707134 | Sep 1997 → May 2000 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 454 trials · 2 met primary · 6 missed | ||||||
| Phase 4 | NCT06127433 | Mar 2023 → May 2024 | — | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 4 | NCT06739473 | Jan 2023 → Dec 2024 overdue | obesity disorder | Turku University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04834362 | Apr → Jun 2021 | hyperglycemia, stroke disorder | National Institute of Neurosciences and Hospital, Dhaka | Completed | Missed primary |
| Phase 4 | NCT04772729 | Mar 2021 → Mar 2023 | type 1 diabetes mellitus | Medical University of Warsaw | Unknown | No outcome recorded |
| Phase 4 | NCT04620967 | Feb 2021 → Jun 2022 | type 1 diabetes mellitus | Kirsten Nørgaard | Unknown | No outcome recorded |
| Phase 4 | NCT04538352 | Jan 2021 → Mar 2023 | type 2 diabetes mellitus | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT04019821 | Jan 2020 → Jan 2023 | type 1 diabetes mellitus | Medical University of Warsaw | Completed | No outcome recorded |
| Phase 4 | NCT04012138 | Dec 2019 → Dec 2025 | — | Nantes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04157738 | Nov 2019 → Dec 2020 | type 1 diabetes mellitus | Emory University | Completed | Met primary |
| Phase 4 | NCT03554486 | Jul 2018 → Mar 2019 | type 1 diabetes mellitus | Stanford University | Completed | Missed primary |
| Phase 4 | NCT03511521 | Mar 2018 → Aug 2019 | hyperglycemia | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03328845 | Jan 2017 → Nov 2020 | type 1 diabetes mellitus | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Completed | No outcome recorded |
| Phase 4 | NCT02590016 | Sep 2015 → Dec 2020 | gestational diabetes | Tampere University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02453685 | Aug 2015 → Sep 2016 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 4 | NCT03226210 | Feb 2015 → May 2016 | type 2 diabetes mellitus | Nanjing First Hospital, Nanjing Medical 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 | NCT01648218 | Aug 2012 → Apr 2013 | — | Vancouver General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01654120 | Dec 2011 → Nov 2013 | type 2 diabetes mellitus | Mountain Diabetes and Endocrine Center | Completed | No outcome recorded |
| Phase 4 | NCT01486966 | Nov 2011 → Jun 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01678235 | Sep 2011 → Sep 2012 | type 1 diabetes mellitus | Medical University of Warsaw | Completed | Missed primary |
| Phase 4 | NCT01407289 | Jun 2011 → Apr 2012 | type 2 diabetes mellitus | Medical University of Graz | Completed | No outcome recorded |
| Phase 4 | NCT01333514 | Apr 2011 → Dec 2012 | type 2 diabetes mellitus | Rush University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT01121835 | Feb 2010 → Mar 2012 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01828970 | Jan 2010 → Sep 2012 | diabetes mellitus | Centre Europeen d'Etude du Diabete | Completed | No outcome recorded |
| Phase 4 | NCT00942318 | Mar 2009 → Feb 2013 | type 2 diabetes mellitus | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00807092 | Dec 2008 → Oct 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00657943 | Apr 2008 → Dec 2012 | atherosclerosis, type 2 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | Missed primary |
| Phase 4 | NCT00607087 | Jan 2008 → Jun 2009 | type 1 diabetes mellitus | Sanofi | Completed | Missed primary |
| Phase 4 | NCT00564395 | Aug 2007 → Dec 2009 | type 1 diabetes mellitus | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00998335 | Jun 2007 → Feb 2010 | type 2 diabetes mellitus | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT00771693 | May 2007 → Jul 2011 | hyperglycemia, type 2 diabetes mellitus | Karolinska Institutet | Completed | No outcome recorded |
| Phase 4 | NCT00346996 | May 2007 → Nov 2011 | type 1 diabetes mellitus | Lise Tarnow | Completed | Met primary |
| Phase 4 | NCT00449839 | Apr 2007 → Oct 2008 | diabetes mellitus | Aarhus University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00590226 | Dec 2006 → Jan 2008 | type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00282451 | Feb → Aug 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01486862 | Oct 2005 → Jul 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00274274 | Sep 2005 → Nov 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00254085 | Mar 2005 → Mar 2006 | type 2 diabetes mellitus | University Hospital, Gentofte, Copenhagen | Unknown | No outcome recorded |
| Phase 4 | NCT00494988 | Dec 2004 → Apr 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00145353 | Nov 2004 → Jun 2006 | type 1 diabetes mellitus | Odense University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00095446 | Jul 2004 → Mar 2005 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00593255 | Jul 2004 → Apr 2005 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00571935 | Aug 2003 → Oct 2004 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00572806 | Feb 2003 → Feb 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00121966 | Jan 2003 → Jul 2007 | type 2 diabetes mellitus | Odense University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00597233 | Oct → Dec 2002 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00365170 | Sep 2002 → Apr 2005 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01697631 | Jul 2002 → Apr 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01467141 | Jun 2002 → Oct 2003 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01487798 | Jun 2002 → Nov 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01649570 | Mar 2002 → Aug 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00676819 | Jan → Jul 2002 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00663624 | — | diabetes mellitus | Emory University | Withdrawn | No outcome recorded Stop: Business |
| Phase not applicable15 trials · 1 met primary · 1 missed | ||||||
| — | NCT07652528 | Aug 2026 → Jun 2028 expected | glucose metabolism disease, sudden sensorineural hearing loss | Hallym University | Not yet recruiting | No outcome recorded |
| — | NCT05199714 | Feb 2022 → Mar 2023 | type 1 diabetes mellitus | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| — | NCT04200313 | Mar 2020 → Oct 2021 | type 1 diabetes mellitus | Jaeb Center for Health Research | Completed | Met primary |
| — | NCT04184466 | Oct → Dec 2018 | — | Geropharm | Completed | No outcome recorded |
| — | NCT02518022 | Sep 2015 → Jun 2016 | hypoglycemia, type 1 diabetes mellitus | Kinderkrankenhaus auf der Bult | Withdrawn | No outcome recorded |
| — | NCT02144441 | Jun → Oct 2014 | diabetes mellitus | University of Pennsylvania | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01947556 | Mar → Nov 2014 | diabetes mellitus | University Medical Center Nijmegen | Completed | No outcome recorded |
| — | NCT01974544 | May 2013 → Dec 2015 | type 2 diabetes mellitus | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| — | NCT01088451 | Dec 2009 → Mar 2010 | type 1 diabetes mellitus | University Hospital Hradec Kralove | Unknown | No outcome recorded |
| — | NCT01588743 | Oct 2008 → Dec 2012 | type 2 diabetes mellitus | Li Guangwei | Unknown | No outcome recorded |
| — | NCT00625781 | Feb 2008 → Jun 2012 | glucose intolerance, macrosomia adiposa congenita | Region Örebro County | Completed | No outcome recorded |
| — | NCT00353431 | Dec 2006 → Apr 2010 | hyperglycemia | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| — | NCT00283218 | Jan → Aug 2006 | type 1 diabetes mellitus | University of Aarhus | Completed | No outcome recorded |
| — | NCT00464854 | Jul 2005 → Sep 2006 | diabetes mellitus | Assaf-Harofeh Medical Center | Terminated | No outcome recorded |
| — | NCT00410033 | Dec 1989 → May 2006 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Comparator or background therapy183 trials | ||||||
| Phase 1 | NCT05104424 Comparator | Dec 2021 → Aug 2022 | olfactory nerve disorder, oral sensibility, disturbance of | Ministry of Health, Saudi Arabia | Unknown | No outcome recorded |
| Phase 1 | NCT04698018 Comparator | Apr 2021 → Jul 2022 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03449433 Comparator | Mar → Aug 2018 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03179332 Comparator | Jun → Sep 2017 | type 1 diabetes mellitus | Adocia | Completed | Met primary |
| Phase 1 | NCT02938572 Comparator | Oct 2016 → Jun 2017 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Show all 183 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 52
| Date | Issuer | Release |
|---|---|---|
| 2026-08-13 | Arecor Limited | Results Peer-Reviewed Publication of AT278 Study in Diabetes, Obesity and Metabolism journal arecor.com ↗
AT278 exhibited a significantly faster insulin absorption than both standard U100 concentration insulin aspart and U500 human regular insulin. |
| 2026-07-30 | Meitheal Pharmaceuticals, Inc. | Regulatory Meitheal Pharmaceuticals Announces FDA Approval of Garzulys™ (insulin aspart-fsan) Injection meithealpharma.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys™ (insulin aspart-fsan) injection, a biosimilar to NovoLog® (insulin aspart). |
| 2026-07-30 | Arecor Limited | Results Diabetes, Obesity and Metabolism article – A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI arecor.com ↗
A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI |
| 2026-07-28 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee’s Insulin Aspart 30 Injection Approved in India ganlee.com ↗
Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) recently announced that its manufactured insulin aspart 30 injection has been granted import and marketing approval by India's Central Drugs Standard Control Organization (CDSCO). |
| 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. |
| 2025-07-08 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals' Insulin Aspart Receives Approval in Argentina ganlee.com ↗
Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee, stock code: 603087.SH) announced that its insulin aspart injection, developed in collaboration with a local pharmaceutical company in Argentina, has received approval from the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT. |
| 2025-06-09 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals' Insulin Aspart Receives NPRA Approval in Malaysia ganlee.com ↗
Beijing, China, Recently – Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee, stock code: 603087.SH) announced that its fast-acting insulin aspart cartridge, developed in collaboration with local pharmaceutical partner, has received marketing approval from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA). |
| 2025-03-25 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals' Insulin Aspart 30 Receives NPRA Approval in Malaysia ganlee.com ↗
Gan & Lee Pharmaceuticals, a leading global biopharmaceutical company (hereinafter referred to as Gan & Lee, stock code: 603087.SH), has announced that its insulin aspart 30, developed in collaboration with a local Malaysian pharmaceutical company, has received regulatory approval from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. |
| 2024-10-16 | Wockhardt | Regulatory Wockhardt files fast – acting Insulin Aspart injection (ASPARAPID™) with DCGI; strengthens commitment to diabetes management wockhardt.com ↗
Wockhardt, a global pharmaceutical and biotechnology major, announces the filing of its fast -acting insulin analog, Aspart injection (ASPARAPID TM), with the Drugs Controller General of India (DCGI). |
| 2024-10-16 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies ganlee.com ↗
After 16 weeks of treatment in patients with Type 2 diabetes, the premixed dual insulin analog GZR101 injection showed superior efficacy in reducing HbA1c and postprandial glucose compared to insulin degludec/insulin aspart (Ryzodeg ® ). |
| 2024-08-08 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Teams Up with Algerian Pharmaceutical Company to Pioneer New Horizons in African Market ganlee.com ↗
This approval marks the successful launch of Gan & Lee's first localization project in the African market, opening a new chapter in Gan & Lee's global pharmaceutical landscape. |
| 2024-07-11 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Received Approval of Local-filling Insulin Aspart 30 Injection in Bangladesh ganlee.com ↗
This approval marks the successful implementation of Gan & Lee's first overseas localized Insulin Aspart 30 project. |
| 2024-01-26 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Insulin Aspart Injection in Bolivia ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) recently announced that its insulin aspart injection has been approved for the treatment of diabetes by the Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) of Bolivia. |
| 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. |
| 2023-12-08 | Gan and Lee Pharmaceuticals, USA | Results IDF 2023丨Debut of the Phase III Clinical Evidence in China for Rapilin30 ganlee.com ↗
The results showed that Rapilin ® 30 is similar in efficacy and safety to the reference product, NovoMix ® 30. |
| 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 the Marketing Authorisation Application of Gan & Lee Insulin Aspart biosimilar starts upon the Positive Validation Letter ganlee.com ↗
Insulin aspart 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. |
| 2023-06-14 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals on the official acceptance of the biologics license application for the proposed biosimilar insulin aspart injection by the US FDA ganlee.com ↗ |
| 2023-01-04 | Lannett Company, Inc. | Results LANNETT PROVIDES DEVELOPMENT UPDATE ON BIOSIMILAR INSULIN PRODUCTS investorroom.com ↗
The company said results from the study of Lannett/HEC biosimilar insulin aspart versus US NovoLog® (the reference biologic) indicated the products were highly comparable when animals were dosed with equal quantities of the drugs via subcutaneous route. |
| 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. |
| 2022-08-24 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces Approval of Insulin Aspart in Kazakhstan ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce its insulin aspart product has been approved by the Ministry of Health of the Republic of Kazakhstan for the treatment of diabetes. |
| 2022-05-26 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces the Approval of Insulin Aspart (Rapilog) in Bangladesh ganlee.com ↗
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce that the locally filled Insulin Aspart finished product co-produced by Gan & Lee and the local partner in Bangladesh has been approved by the Bangladesh Directorate General of Drug Administration (DGDA). |
| 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 aspart (GL-ASP) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin aspart. |
| 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. |
| 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 ↗
In this study using insulin pumps, BioChaperone Lispro U100 displayed faster-on and faster -off metabolic effects compared to Novolog ®, confirming previous findings in studies versus Humalog® |
| 2017-09-29 | Novo Nordisk A/S | Regulatory Novo Nordisks nye hurtigtvirkende måltidsinsulin, Fiasp®, godkendt i USA novonordisk.com ↗
Bagsværd, den 29. september 2017 - Novo Nordisk meddeler i dag, at de amerikanske sundhedsmyndigheder, FDA, har godkendt Fiasp® (hurtigtvirkende insulin aspart), en ny hurtigtvirkende måltidsinsulin, til behandling af voksne med diabetes. |
| 2017-09-29 | Novo Nordisk A/S | Regulatory Novo Nordisk's new fast-acting mealtime insulin Fiasp® approved in the US novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Fiasp® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes. |
| 2017-03-29 | Novo Nordisk A/S | Regulatory Novo Nordisk genindsender registreringsansøgningen for hurtigtvirkende insulin aspart i USA novonordisk.com ↗
På denne baggrund har Novo Nordisk genindsendt registreringsansøgningen for hurtigtvirkende insulin aspart. |
| 2017-01-10 | Novo Nordisk A/S | Regulatory Fiasp® (hurtigtvirkende insulin aspart) godkendt i Europa novonordisk.com ↗
Bagsværd, den 10. januar 2017 - Novo Nordisk meddeler i dag, at Europa-Kommissionen har givet markedsføringstilladelse til Fiasp® til behandling af diabetes hos voksne. |
| 2017-01-10 | Novo Nordisk A/S | Regulatory Fiasp® (fast-acting insulin aspart) approved in Europe novonordisk.com ↗
Novo Nordisk today announced that the European Commission has granted marketing authorisation for Fiasp® for the treatment of diabetes in adults. |
| 2016-11-11 | Novo Nordisk A/S | Regulatory Novo Nordisk receives positive opinion from the European regulatory authorities for Fiasp® (fast-acting insulin aspart) for the treatment of diabetes novonordisk.com ↗
The CHMP recommends Fiasp®, the intended brand name for fast-acting insulin aspart, to be indicated for use as the bolus component of basal-bolus therapy in combination with basal insulin and for continuous subcutaneous insulin infusion via an insulin pump. |
| 2016-11-11 | Novo Nordisk A/S | Regulatory Novo Nordisk får positiv udtalelse fra de europæiske lægemiddelmyndigheder om Fiasp® (hurtigtvirkende insulin aspart) til behandling af diabetes novonordisk.com ↗
CHMP anbefaler, at Fiasp®, det planlagte varemærke for hurtigtvirkende insulin aspart, indiceres til brug som boluskomponenten i basal-bolus-behandling i kombination med basalinsulin og til kontinuerlig subkutan infusion via en insulinpumpe. |
| 2016-10-07 | Novo Nordisk A/S | Regulatory Novo Nordisk modtager Complete Response Letter i USA vedrørende hurtigerevirkende insulin aspart novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har modtaget et Complete Response Letter fra de amerikanske sundhedsmyndigheder, FDA, vedrørende registreringsansøgningen for hurtigerevirkende insulin aspart. |
| 2016-10-07 | Novo Nordisk A/S | Regulatory Novo Nordisk receives Complete Response Letter in the US for faster-acting insulin aspart novonordisk.com ↗
Bagsværd, Denmark 7 October 2016 - Novo Nordisk today announced that it has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Application for faster-acting insulin aspart. |
| 2015-12-09 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning for hurtigerevirkende insulin aspart i USA til behandling af type 1- og type 2-diabetes novonordisk.com ↗
Bagsværd, den 9. december 2015 - Novo Nordisk meddeler i dag, at virksomheden har indsendt registreringsansøgning for hurtigerevirkende insulin aspart til de amerikanske sundhedsmyndigheder (FDA). |
| 2015-12-04 | Novo Nordisk A/S | Regulatory Novo Nordisk indsender registreringsansøgning for hurtigerevirkende insulin aspart i EU til behandling af type 1- og type 2-diabetes novonordisk.com ↗
Novo Nordisk meddeler i dag, at virksomheden har indsendt ansøgning om markedsføringstilladelse (MAA) til Det Europæiske Lægemiddelagentur for hurtigerevirkende insulin aspart. |
| 2015-03-25 | Novo Nordisk A/S | Results Novo Nordisk A/S : Novo Nordisk afslutter fase 3a-studier, der sammenligner hurtigerevirkende insulin aspart med NovoRapid® i type 1- og type 2-diabetes novonordisk.com ↗
Bagsværd, den 25. marts 2015 - Novo Nordisk offentliggør i dag de overordnede resultater fra de sidste fase 3a-studier med hurtigerevirkende insulin aspart, onset® 1 og onset® 2. |
| 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 | Halozyme Therapeutics | Results Halozyme Presents Positive Data from Two Ultrafast Insulin Clinical Trials with Human Hyaluronidase Enzyme - rHuPH20 - at ADA 2012 halozyme.com ↗
Human Hyaluronidase (rHuPH20) Provides Consistent Ultrafast Insulin Absorption and Action Over Three Days of Continuous Subcutaneous Infusion |
| 2011-11-07 | Novo Nordisk A/S | Results Novo Nordisk A/S: DegludecPlus giver bedre blodsukkerregulering end insulin glargin i et fase 3a-studie med japanske type 2-diabetikere novonordisk.com ↗ |
| 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 ↗ |
| 2011-10-27 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Positive Results From Enzyme-Augmented Insulin Pump Trial halozyme.com ↗
The data demonstrated that pre-administration of 150 units of rHuPH20 (approximately 1.3 micrograms of enzyme) led to consistent insulin exposure over the infusion set life and superior glucose control following meals. |
| 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. |
| 2011-06-24 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Demonstrates Reduced Variability of Insulin Absorption for Type 1 Diabetes Patients Using Insulin Pumps halozyme.com ↗
Insulin exposure beyond 2 hours after the bolus decreased by 42% for the combination compared to aspart alone (p = 0.0003). |
| 2011-04-14 | Halozyme Therapeutics | Results Halozyme's Ultrafast Insulin Generates Faster-In and Faster-Out Profile for Type 1 Diabetes Patients Using Insulin Pumps halozyme.com ↗
The initial results from Halozyme's first pump study show that the faster pharmacokinetic and glucodynamic findings consistently demonstrated with mealtime subcutaneous insulin injections are also observed in the CSII setting," stated Doug Muchmore, M.D., vice president of endocrinology clinical development. |
| 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. |
All press releases naming this drug 80 releases
Evidence & citations 40 cited values
Every value below carries the sentence it was read from. 389 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin aspart | “Brain responses to viewing food and non-food pictures were measured using functional Magnetic Resonance Imaging in 32 type 1 diabetic patients, after each of two 12-week...” PMID 24739875 ↗ Apr 2014262“This is a single-center randomized open label active-controlled crossover trial comparing efficacy and safety of fast acting insulin aspart (FA) (FIASP®) versus insulin aspart...” PMID 33090016 ↗ Mar 2021 “Participants will receive an intravenous infusion of insulin aspart (Novolog™ or other rapid-acting insulin analog) for several hours prior to MK-1293 or EU-Lantus™ dosing in...” NCT02059174 ↗ “The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and...” PMID 33837106 ↗ Apr 2021 “This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard...” NCT05754424 ↗ “We evaluated the safety and efficacy of day-and-night fully closed-loop insulin therapy using faster (Faster-CL) compared with standard insulin aspart (Standard-CL) in young...” PMID 31575640 ↗ Oct 2019 “This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM)...” NCT04079413 ↗ “Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal.” NCT02680054 ↗ “Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.” NCT05013229 ↗ “We aimed to assess the efficacy of a novel faster-acting insulin aspart (Fiasp) plus pramlintide fully closed-loop system that does not require meal input.” PMID 34580055 ↗ Sep 2021 “Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening.” NCT02688933 ↗ |
| Known as | aspart | “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 ↗35“CONCLUSIONS: Long-term treatment with the insulin analogues detemir + aspart was superior to NPH + aspart in reducing HbA(1c), with added benefits of less major and nocturnal...” PMID 18387078 ↗ Apr 2008 “Multiple daily injections which consist of a single injection of basal insulin(insulin Glargine) and 3 injections of bolus insulin(rapid acting insulin Glulisine or Aspart)” NCT03112538 ↗ “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 ↗ “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)” NCT02490098 ↗ “Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846857 ↗ |
| Known as | Aspart (Novolog) | “Aspart (Novolog)” NCT01702311 ↗ |
| Known as | aspart insulin | “A = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP)” NCT04381429 ↗ |
| Known as | BIAsp 30 | “a 30/70 (rapid/intermediate-acting) premixed suspension of the rapid-acting insulin analogue insulin aspart (BIAsp30) was compared with a similar premixed suspension of...” PMID 11009049 ↗ Aug 20001“BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin.” NCT00807092 ↗ |
| Known as | biphasic insulin aspart 30 | “BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin.” NCT00807092 ↗ |
| Known as | Fast-acting insulin aspart | “OBJECTIVE: This multicenter, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus conventional insulin aspart...” PMID 28356319 ↗ Mar 20172“BACKGROUND: Fast-acting insulin aspart (faster aspart) is insulin aspart set in a new formulation with faster initial absorption after subcutaneous administration.” PMID 28185141 ↗ May 2017 “Fast-acting insulin aspart (faster aspart) is an ultra-fast-acting formulation of insulin aspart (IAsp).” PMID 30402720 ↗ May 2019 |
| Known as | faster aspart | “OBJECTIVE: This multicenter, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus conventional insulin aspart...” PMID 28356319 ↗ Mar 20172“BACKGROUND: Fast-acting insulin aspart (faster aspart) is insulin aspart set in a new formulation with faster initial absorption after subcutaneous administration.” PMID 28185141 ↗ May 2017 “Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with faster absorption.” PMID 27873152 ↗ Jan 2017 |
| Known as | faster insulin aspart | “Participants were randomly assigned in a 1:1:1:1:1:1 ratio to a sequence of the three interventions, with faster insulin aspart used in all interventions.” PMID 38906614 ↗ Jul 2024 |
| Known as | Faster-acting insulin aspart | “INTRODUCTION: Faster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in...” PMID 33837106 ↗ Apr 20213“The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in...” NCT01831765 ↗ “Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with faster absorption.” PMID 27873152 ↗ Jan 2017 “Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)” NCT04853030 ↗ |
| Known as | Fiasp | “The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection...” NCT02089451 ↗13“The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in...” NCT01831765 ↗ “Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy: To Assess How the 670G System Adapts to the Introduction of Fiasp® Insulin” NCT03554486 ↗ “We aimed to assess the efficacy of a novel faster-acting insulin aspart (Fiasp) plus pramlintide fully closed-loop system that does not require meal input.” PMID 34580055 ↗ Sep 2021 “Single subcutaneous administration of Fiasp® (insulin aspart)” NCT03179332 ↗ “FIAsp (faster-acting insulin aspart)” NCT01999322 ↗ |
| Known as | Gan & Lee Insulin Aspart | “A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products...” NCT04237129 ↗ |
| Known as | GL-Asp | “METHODS: Three phase 1, randomized, double-blind, three-period crossover trials compared single doses of the proposed biosimilar insulin analogues aspart (GL-Asp, n = 36),...” PMID 37735841 ↗ Sep 2023 |
| Known as | GP-Asp | “Aim: To compare safety and efficacy of GP40071 insulin aspart (GP-Asp) and NovoRapid® (NN-Asp).” PMID 33928797 ↗ Apr 2021 |
| Known as | GP40071 | “Aim: To compare safety and efficacy of GP40071 insulin aspart (GP-Asp) and NovoRapid® (NN-Asp).” PMID 33928797 ↗ Apr 2021 |
| Known as | IAsp | “The aim of this study was to investigate the association between baseline characteristics [HbA1c and body mass index (BMI)] and the effect of mealtime fast-acting insulin...” PMID 30547388 ↗ Dec 201839“This is a single-center randomized open label active-controlled crossover trial comparing efficacy and safety of fast acting insulin aspart (FA) (FIASP®) versus insulin aspart...” PMID 33090016 ↗ Mar 2021 “OBJECTIVE: To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without...” PMID 32209647 ↗ Mar 2020 “OBJECTIVES: Preprandial insulin injection in preschool children is complicated by irregular eating habits. Postprandial injection of rapid-acting insulin analogs such as...” PMID 17850471 ↗ Oct 2007 “Patients were randomized 1:1 (age stratified: 1-<6 years; 6-<12 years; 12-<18 years) to IDegAsp once daily (OD) plus insulin aspart (IAsp) for remaining meals (IDegAsp + IAsp),...” PMID 30014589 ↗ Aug 2018 “The efficacy and safety of insulin aspart (IAsp), a rapid-acting human insulin analogue, were compared with regular human insulin (HI) as the bolus component of basal-bolus...” PMID 17888133 ↗ Oct 2007 “AIM: To evaluate the efficacy and safety of mealtime or post-meal fast-acting insulin aspart (faster aspart) vs mealtime insulin aspart (IAsp), both in combination with insulin...” PMID 30259644 ↗ Oct 2018 “AIM: Two treatment strategies were compared in patients with type 2 diabetes (T2DM) on basal insulin requiring intensification: addition of once-daily (OD) liraglutide (Lira)...” PMID 24443830 ↗ Feb 2014 “To evaluate efficacy and tolerability of a co-formulation of insulin degludec and insulin aspart (IDegAsp) with insulin aspart (IAsp) at other meals compared with basal-bolus...” PMID 22933438 ↗ Aug 2012 “The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with...” NCT01697631 ↗ “OBJECTIVE: This multicenter, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus conventional insulin aspart...” PMID 28356319 ↗ Mar 2017 |
| Known as | Insulin aspart (Novo Rapid, Novo Nordisk) | “Insulin aspart (Novo Rapid, Novo Nordisk)” NCT04772729 ↗ |
| Known as | insulin aspart (NovoRapid, NovoLog) | “insulin aspart (NovoRapid, NovoLog)” NCT00000620 ↗ |
| Known as | Insulin aspart - insulin Novolog | “Insulin aspart - insulin Novolog” NCT00461331 ↗ |
| Known as | Insulin aspart = Novolog (Novo Nordisk) | “Insulin aspart = Novolog (Novo Nordisk)” NCT00998335 ↗ |
| Known as | insulin aspart protamine/insulin aspart 70/30 mix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00821795 ↗ |
| Known as | Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00888732 ↗ |
| Known as | Insulin Aspart/NovoRapid | “Insulin Aspart/NovoRapid” NCT00449839 ↗ |
| Known as | Insulin Fiasp | “Insulin Fiasp” NCT03770767 ↗ |
| Known as | insulin levemir / aspart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00346996 ↗ |
| Known as | insuline asparte | “10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus” NCT04012138 ↗ |
| Known as | NN-Asp | “The biosimilar SAR341402 insulin aspart (SAR-Asp) was compared to its originator NovoLog®/NovoRapid® insulin aspart (NN-Asp)” PMID 33432547 ↗ Jan 20211“originator insulin aspart (100 U/mL; NN-Asp; NovoLog®)” PMID 31833801 ↗ Jan 2020 |
| Known as | NovoLog | “This is a single-center randomized open label active-controlled crossover trial comparing efficacy and safety of fast acting insulin aspart (FA) (FIASP®) versus insulin aspart...” PMID 33090016 ↗ Mar 202129“The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose...” NCT00065130 ↗ “Participants will receive an intravenous infusion of insulin aspart (Novolog™ or other rapid-acting insulin analog) for several hours prior to MK-1293 or EU-Lantus™ dosing in...” NCT02059174 ↗ “An Open-Label, Multi Center, Clinical Trial: External Continuous Subcutaneous Infusion of Insulin Using Insulin Aspart (NovoLog®) in Subjects With Type 1 and Insulin Requiring...” NCT00095446 ↗ “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 ↗ “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 ↗ “randomly assigned to receive a dose of 0-to-120 IU of NovoLog (Insulin Aspart) before being randomized to 20 min of exercise or sitting control condition” PMID 33856613 ↗ Apr 2021 “rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])” NCT00467649 ↗ “United States-sourced insulin aspart (NovoLog®), and European Union-sourced insulin aspart (NovoRapid®)” PMID 31825248 ↗ Dec 2019 “originator insulin aspart (100 U/mL; NN-Asp; NovoLog®)” PMID 31833801 ↗ Jan 2020 “Insulin (Aspart Insulin [Novolog], Regular Insulin)” NCT00920725 ↗ |
| Known as | novolog insulin | “Drug: novolog insulin” NCT02496780 ↗ |
| Known as | NovoLog Insulin aspart | “NovoLog Insulin aspart” NCT04292535 ↗ |
| Known as | NovoLog/NovoRapid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03211858 ↗ |
| Known as | NovoMix70 | “premix of insulin aspart (NovoMix70)” NCT01354925 ↗ |
| Known as | NovoRapid | “In a randomized cross-over study, 11 non-diabetic HD patients received a standardised HD session with either: 1) no treatment, 2) glucose infusion (10% glucose, 2.5 mL/kg/h),...” PMID 23557110 ↗ Apr 201347“A Single Centre, Randomized, Balanced Double Blind, Cross-Over Trial Investigating the Bioequivalence of NovoRapid® Produced by the Current Process and Insulin Aspart With the...” NCT01486914 ↗ “The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and...” PMID 33837106 ↗ Apr 2021 “Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.” NCT04772729 ↗ “Participants will be administered intravenous fast acting insulin (NovoRapid, Novo Nordisk, 1 mU/m2 body surface area/min)” NCT06739473 ↗ “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)” NCT02846857 ↗ “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)” NCT02488616 ↗ “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)” NCT02626936 ↗ |
| Known as | PIA | “premixed insulin aspart 70/30 BID (PIA)” PMID 21285388 ↗ Feb 2011 |
| Known as | rapilin | “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 | Standard acting insulin Aspart | “Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid” NCT04853030 ↗ |
| Known as | UBLIN | “Insulin Aspart Injection（UBLIN®）” NCT07600944 ↗ |
| Known as | X14 | “An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble...” NCT01707134 ↗ |
| Modality | Protein / enzyme biologic | “The efficacy and safety of insulin aspart (IAsp), a rapid-acting human insulin analogue, were compared with regular human insulin (HI) as the bolus component of basal-bolus...” PMID 17888133 ↗ Oct 2007 |
| Route | Subcutaneous | “External Continuous Subcutaneous Infusion of Insulin Using Insulin Aspart” NCT00095446 ↗ |