Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment
A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus, Starting or Switching to NovoMix® 30 Treatment
1 other identifier
observational
423
1 country
1
Brief Summary
This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedJanuary 6, 2017
January 1, 2017
1.2 years
March 5, 2012
January 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia
Secondary Outcomes (3)
Change from baseline in HbA1c (glycosylated haemoglobin)
Mean FPG (fasting plasma glucose)
Overall, daytime and nocturnal frequency of hypoglycaemic events
Study Arms (1)
BIAsp 30 users
Interventions
Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.
Eligibility Criteria
Patients who started insulin therapy with biphasic insulin aspart 30 and subjects who switched from other insulin regimens to biphasic insulin aspart 30 by prescription of their physician as part of routine clinical practice in order to improve glycemic control. The selection of patients was at the discretion of the treating physician.
You may qualify if:
- Subjects with type 2 diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Copenhagen S, 2300, Denmark
Related Publications (1)
Breum L, Almdal T, Eiken P, Lund P, Christiansen E; Danish BIAsp Study Group. Initiating or switching to biphasic insulin aspart 30/70 therapy in subjects with type 2 diabetes mellitus. An observational study. Rev Diabet Stud. 2008 Fall;5(3):154-62. doi: 10.1900/RDS.2008.5.154. Epub 2008 Nov 10.
PMID: 19099087RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2012
First Posted
March 8, 2012
Study Start
February 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
January 6, 2017
Record last verified: 2017-01