biphasic insulin aspart
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01697618 | Apr 1997 → Nov 1998 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 314 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT00476437 | Apr → Nov 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00318786 | Apr 2006 → Jun 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00313001 | Apr 2006 → Jul 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00184574 | Apr 2005 → Mar 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00097279 | Aug 2004 → Aug 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00564668 | Jun 2004 → Apr 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| 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 | NCT00280046 | Nov 2003 → Jul 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00612599 | Sep 2003 → Jun 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 3 | NCT00617565 | Jul → Nov 2003 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00598793 | Nov 2002 → Mar 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01486381 | Mar 2002 → May 2003 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01467375 | Jan 2001 → Oct 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 413 trials · 2 met primary | ||||||
| Phase 4 | NCT00537277 | Oct 2007 → Jan 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00469092 | May 2007 → Apr 2008 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT00282451 | Feb → Aug 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00184561 | Jul 2005 → Jul 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00101751 | Oct 2004 → Jun 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00184626 | Sep 2004 → Oct 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00624364 | May 2004 → May 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00600366 | Mar 2004 → Jan 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00592969 | Dec 2003 → Nov 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00605111 | Dec 2003 → Oct 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00619697 | Dec 2003 → Mar 2005 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT01467401 | Aug 2002 → May 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01704378 | Apr 2001 → Mar 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT00613951 Comparator | Jan → Aug 2008 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT02762578 Comparator | May 2016 → May 2017 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT02648217 Comparator | Jan → Sep 2016 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 3 | NCT00184600 Comparator | Nov 2004 → Aug 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00082407 Comparator | Nov 2003 → Jul 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2006-09-14 | Eli Lilly and Company | Results Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Biphasic Insulin Aspart lilly.com ↗
This long-term clinical trial is the second study conducted at European clinical centers demonstrating that exenatide can control blood sugar as effectively as insulin.(1) |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-06-28 | Sanofi | Media Update: New Soliqua®* data shows improved blood sugar control without weight gain versus premixed insulin sanofi.com ↗ |
| 2006-09-14 | Eli Lilly and Company | Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Biphasic Insulin Aspart lilly.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | biphasic insulin aspart | “biphasic insulin aspart” NCT00605020 ↗ |
| Known as | BIAsp | “AIMS: To show that a thrice daily meal-time biphasic insulin aspart (BIAsp) treatment regimen is as efficacious as a 4 times daily basal-bolus regimen with human isophane...” PMID 17115349 ↗ Oct 2006 |
| Known as | BIAsp 30 | “AIM: To evaluate the efficacy and safety of adding biphasic insulin aspart 30 (BIAsp30; NovoMix 30) to existing oral antidiabetic agents (OADs) vs. optimizing OADs in a...” PMID 17593237 ↗ Jun 200712“Premixed insulin formulations include conventional (e.g. biphasic human insulin 70/30, or 30/70 in European countries, BHI 30) and newer premixed human analogues (e.g. biphasic...” PMID 17697056 ↗ Sep 2007 “OBJECTIVE: To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic...” PMID 19210140 ↗ Jan 2009 “AIMS: To compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) before, during and after Ramadan in patients...” PMID 29183844 ↗ Nov 2017 “twice-daily biphasic insulin aspart 30 (30% soluble and 70% protaminated insulin aspart; BIAsp 30) plus metformin (met) was compared with once-daily insulin glargine (glarg)...” PMID 17115351 ↗ Oct 2006 “OBJECTIVES: To assess the efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) and insulin glargine, administered once daily in subjects with type 2 diabetes...” PMID 19821654 ↗ Dec 2009 “OBJECTIVE: To assess the efficacy and safety of twice- and thrice-daily biphasic insulin aspart 30 (BIAsp 30) in Chinese subjects with type 2 diabetes inadequately controlled...” PMID 18268073 ↗ Feb 2008 “Efficacy and safety of biphasic insulin aspart (BIAsp 30, 30% short-acting and 70% intermediate-acting insulin aspart) added to an optimized treatment of metformin and pioglitazone” PMID 17941873 ↗ Oct 2007 “OBJECTIVE: This study examined the efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) monotherapy in insulin-naive patients with Type 2 diabetes mellitus.” PMID 18001251 ↗ Dec 2007 “Here, we compare the efficacy and safety of IDegAsp, an alternative IDegAsp formulation (AF: containing 45% IAsp), and biphasic IAsp 30 (BIAsp 30).” PMID 22660026 ↗ Jun 2012 “A disadvantage of twice-daily regimens of biphasic insulin aspart 30 (BIAsp 30) is that lunchtime control” PMID 18158078 ↗ Nov 2007 |
| Known as | BIAsp 30/70 | “biphasic insulin aspart 30/70 (BIAsp 30/70, premixed 30% soluble and 70% protaminated insulin aspart in one injection) compared to insulin glargine treatment” PMID 16368057 ↗ Dec 2005 |
| Known as | BIAsp 50 | “AIM: To evaluate clinical efficacy and safety of biphasic insulin aspart (BIAsp) 30 twice daily (b.i.d.) vs. BIAsp 50 or BIAsp 70 (high-mix regimens) thrice daily (t.i.d.) all...” PMID 19476479 ↗ May 2009 |
| Known as | BIAsp 70/30 | “Safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 70/30, prebreakfast and presupper) were compared with once-daily insulin glargine in type 2 diabetic subjects...” PMID 15677776 ↗ Feb 2005 |
| Known as | BIAsp70 | “AIM: To evaluate clinical efficacy and safety of biphasic insulin aspart (BIAsp) 30 twice daily (b.i.d.) vs. BIAsp 50 or BIAsp 70 (high-mix regimens) thrice daily (t.i.d.) all...” PMID 19476479 ↗ May 20091“An insulin analogue formulation with a 7:3 ratio of rapid-acting and intermediate-acting fractions, biphasic insulin aspart 70 (BIAsp70) was developed to supplement basal...” PMID 24843416 ↗ Jun 2010 |
| Known as | biphasic insulin aspart 30 | “OBJECTIVE: To assess the efficacy and safety of twice- and thrice-daily biphasic insulin aspart 30 (BIAsp 30) in Chinese subjects with type 2 diabetes inadequately controlled...” PMID 18268073 ↗ Feb 20081“Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: The ACTION Study” PMID 17941873 ↗ Oct 2007 |
| Known as | biphasic insulin aspart 70/30 | “OBJECTIVE: To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic...” PMID 19210140 ↗ Jan 20092“OBJECTIVES: To assess the efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) and insulin glargine, administered once daily in subjects with type 2 diabetes...” PMID 19821654 ↗ Dec 2009 “self-titration using biphasic insulin aspart 70/30 (BIAsp 30)” PMID 22509859 ↗ Jun 2012 |
| Known as | NovoLog Mix 70/30 | “NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) BID and QD vs. Byetta™ Exenatide) BID on Glycemic Control: A Multicenter, 24-Week, Open-Label, Parallel Group Study in...” NCT00313001 ↗1“biphasic insulin aspart 70/30 (BIAsp 30, NovoLog Mix 70/30)” PMID 21741089 ↗ Jul 2011 |
| Known as | NovoMix 30 | “AIM: To evaluate the efficacy and safety of adding biphasic insulin aspart 30 (BIAsp30; NovoMix 30) to existing oral antidiabetic agents (OADs) vs. optimizing OADs in a...” PMID 17593237 ↗ Jun 20071“The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.” NCT01467401 ↗ |
| Known as | NovoRapid 70 Mix | “Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2...” NCT00318786 ↗ |
| Modality | Protein / enzyme biologic | “30% short-acting and 70% intermediate-acting insulin aspart” PMID 17941873 ↗ Oct 2007 |
| Route | Subcutaneous | “subcutaneously (under the skin) injection” NCT00184600 ↗ |