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NCT00659282: IMPROVE™
Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes
trial testing biphasic insulin aspart in Diabetes in 57,610 participants. Completed in 15 November 2008.
15 November 2008
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 57,610 |
| Start date | 11 September 2006 |
| Primary completion | 15 November 2008 |
| Estimated completion | 15 November 2008 |
| Sites | 11 locations across Italy, Japan, Russia, Greece, Saudi Arabia, Poland, South Korea, Canada |
Drugs / interventions tested
- biphasic insulin aspart — full drug profile →
Conditions studied
- Diabetes — all drugs for Diabetes →
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
Eligibility, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study.
Shah S, Benroubi M, Borzi V, Gumprecht J, et al · · 2009 · cited 32× · PMID 19210701 · DOI 10.1111/j.1742-1241.2009.02012.x -
Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE observational study.
Gumprecht J, Benroubi M, Borzi V, Kawamori R, et al · · 2009 · cited 29× · PMID 19504715 · DOI 10.1111/j.1742-1241.2009.02064.x -
National Variations in Comorbidities, Glycosylated Hemoglobin Reduction, and Insulin Dosage in Asian Patients with Type 2 Diabetes: The FINE-Asia Registry.
Ji L, Tsai ST, Lin J, Bhambani S. · · 2015 · cited 18× · PMID 26494149 · DOI 10.1007/s13300-015-0137-8 -
Predictors of achieving HbA(1c) <7% and no hypoglycaemia 6 months after initiation of biphasic insulin aspart 30 in patients with type 2 diabetes in the IMPROVE study.
Valensi P, Shaban J, Benroubi M, Kawamori R, et al · · 2013 · cited 8× · PMID 23488447 · DOI 10.1185/03007995.2013.786692 -
Biphasic insulin aspart 30 as insulin initiation or replacement therapy: the China cohort of the IMPROVE study.
Yang W, Gao Y, Liu G, Chen L, et al · · 2010 · cited 5× · PMID 19916705 · DOI 10.1185/03007990903364640
Verify or expand the search:
- PubMed search for NCT00659282
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of biphasic insulin aspart
Trials testing the same drug.
- NCT02762578 — Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes · Phase 3 · completed
- NCT02648217 — Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in · Phase 3 · completed
- NCT00184626 — Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With · Phase 4 · completed
- NCT00564668 — Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes · Phase 3 · completed
- NCT00592969 — Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes · Phase 4 · completed
Other recruiting trials for Diabetes
Currently open trials in the same condition.
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Other Novo Nordisk A/S trials
Trials by the same sponsor.
- NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
- NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
- NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
- NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
- NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00659282 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
- Last refreshed: 12 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00659282.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing