Status:
COMPLETED
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combina...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
- Ongoing stable treatment with metformin for at least 2 months
- Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
- Insulin naive
- HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)
Exclusion
- Metformin contraindication according to local practice
- TZD (thiazolidinedione) treatment for the last 5 months before trial start
- Systemic treatment with any corticosteroid 3 months before trial start
- Any disease or condition which according to the Investigator would interfere with the trial
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00469092
Start Date
May 1 2007
End Date
April 1 2008
Last Update
February 23 2017
Active Locations (69)
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1
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1181ACH
2
Novo Nordisk Investigational Site
Ciudad Autonoma de Bs As, Argentina, C1405CWB
3
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, Argentina, C1406FWY
4
Novo Nordisk Investigational Site
Mar del Plata, Argentina, B7602CBM