Status:
COMPLETED
Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control 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 Asia, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effec...
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes for at least 6 months
- Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
- Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
- HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
- Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2
Exclusion
- Any contraindication to insulin detemir or insulin glargine according to the local labelling
- Receipt of any investigational product within 4 weeks
- Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
- Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
- Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT00909480
Start Date
May 1 2009
End Date
June 1 2010
Last Update
March 10 2017
Active Locations (88)
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1
Novo Nordisk Investigational Site
Litchfield Park, Arizona, United States, 85340
2
Novo Nordisk Investigational Site
Searcy, Arkansas, United States, 72143
3
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
4
Novo Nordisk Investigational Site
Concord, California, United States, 94520