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NCT00659282: IMPROVE™

Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes

Completed Last updated 12 January 2018
What this trial tests

trial testing biphasic insulin aspart in Diabetes in 57,610 participants. Completed in 15 November 2008.

Timeline
11 September 2006
Primary endpoint
15 November 2008
15 November 2008

Quick facts

Lead sponsorNovo Nordisk A/S
StatusCompleted
Study typeOBSERVATIONAL
Enrollment57,610
Start date11 September 2006
Primary completion15 November 2008
Estimated completion15 November 2008
Sites11 locations across Italy, Japan, Russia, Greece, Saudi Arabia, Poland, South Korea, Canada

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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:

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Data sources for this page

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