biphasic insulin aspart 30
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT01174303 | Aug → Nov 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00993096 | Sep → Dec 2009 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00824668 | Aug → Oct 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00825253 | Mar → May 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | 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 | NCT01538511 | Jun 2006 → Mar 2007 | 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 | NCT01487811 | May → Nov 2005 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01524809 | Jan → Jun 2001 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01520831 | Apr 1999 → May 2000 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01526980 | May → Nov 2002 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT01009580 | Nov 2009 → Aug 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00627445 | Feb 2008 → Jan 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01527539 | Nov 2001 → Oct 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 410 trials · 5 met primary · 4 missed | ||||||
| Phase 4 | NCT02582242 | Oct 2015 → Mar 2017 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 4 | NCT02453685 | Aug 2015 → Sep 2016 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 4 | NCT01618214 | Jun 2012 → Jan 2013 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT01589653 | May 2012 → Jul 2015 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT01427920 | Sep 2011 → Jul 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 4 | NCT01215435 | Mar 2011 → Sep 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT01278160 | Jan → Sep 2011 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Missed primary |
| Phase 4 | NCT01123980 | May 2010 → Jun 2011 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT00669864 | Nov 2007 → Apr 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT00791895 | Jun 2003 → Oct 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT01134224 Comparator | May → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01051102 Comparator | Jan → Apr 2010 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01868568 Comparator | Apr → Aug 2008 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00842361 Comparator | Jan → Jun 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01059812 Comparator | Feb → Dec 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT03359837 Comparator | Jan 2018 → Jun 2020 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT02449603 Comparator | Nov 2015 → Apr 2018 | type 2 diabetes mellitus | Xijing Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01519674 Comparator | Jun 2012 → Oct 2013 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01068652 Comparator | Mar 2010 → May 2012 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01697631 Background | Jul 2002 → Apr 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
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 10 cited values
Every value below carries the sentence it was read from. 48 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | biphasic insulin aspart 30 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01519674 ↗ |
| Known as | BIAsp | “Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).” NCT01051102 ↗ |
| Known as | BIAsp 30 | “INTRODUCTION: To evaluate the cost-effectiveness of the co-formulation insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart (BIAsp 30), both administered...” PMID 27553066 ↗ Aug 201616“OBJECTIVE Pharmacological profiles of biphasic insulin aspart 30/70 (BIAsp 30) once daily (OD), twice daily (b.i.d.), and three times daily (t.i.d.) were compared with other...” PMID 19487640 ↗ Jun 2009 “This trial compared IDegAsp with biphasic insulin aspart 30 (BIAsp 30) in adults with type 2 diabetes inadequately controlled with once- or twice-daily (OD or BID) pre- or...” PMID 24812432 ↗ May 2014 “The study of once- and twice-daily biphasic insulin aspart 30 (BIAsp 30) with sitagliptin, and twice-daily BIAsp 30 without sitagliptin, in patients with type 2 diabetes...” PMID 25488587 ↗ Dec 2014 “In this 6-week, open-label, parallel-group, controlled trial, 66 participants were randomized (1:1) to receive either IDegAsp or biphasic insulin aspart 30 (BIAsp 30) twice...” PMID 27560769 ↗ Oct 2016 “Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in...” NCT01068652 ↗ “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 ↗ “The study aimed to confirm the efficacy, through non-inferiority, of patient-driven versus investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) in terms of...” PMID 25180608 ↗ Sep 2014 “Type 2 diabetes patients on premixed insulin are commonly prescribed biphasic insulin with low prandial insulin content, such as biphasic insulin aspart (BIAsp) 30, comprising...” PMID 19049377 ↗ Dec 2008 “The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID).” PMID 26816605 ↗ May 2015 “To compare the efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) administered three times daily (TID) vs. twice daily (BID), plus metformin,” PMID 30872064 ↗ Mar 2019 |
| Known as | biphasic insulin aspart 30/70 | “Biphasic insulin aspart 30/70: pharmacokinetics and pharmacodynamics compared with once-daily biphasic human insulin and Basal-bolus therapy.” PMID 19487640 ↗ Jun 2009 |
| Known as | biphasic insulin aspart 70/30 | “biphasic insulin aspart 70/30 (BIAsp 30)” PMID 16367883 ↗ Jan 2006 |
| Known as | NN-X14Mix30 | “A Two-centre, Randomised, Open-labelled, Four-week, Parallel-group Pharmacokinetics Trial in Japanese Type 2 Diabetic Subjects Characterising the Insulin Profile of Thrice...” NCT01538511 ↗ |
| Known as | NovoLog Mix 70/30 | “Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol)” NCT01487811 ↗ |
| Known as | NovoMix 30 | “Comparing Efficacy and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 (Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin” NCT02582242 ↗2“compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus.” NCT01868568 ↗ “Biphasic Insulin Aspart 30 (NovoMix® 30)” NCT01865305 ↗ |
| Modality | Protein / enzyme biologic | “The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.” NCT00842361 ↗ |
| Route | Subcutaneous | “s.c. (under the skin) injection before dinner” NCT00627445 ↗ |