Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes (BOOST™)
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of this clinical trial is to compare NN5401 with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral antidiabetic drugs (OADs). Subjects will continue their ongoing treatment with OADs (oral anti-diabetic drugs) in the trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)|
- HbA1c change from baseline [ Time Frame: after 26 weeks of treatment. ] [ Designated as safety issue: No ]
- Plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
NN5401 injected subcutaneously (under the skin) once daily with main meal. The dose will be individually adjusted.
|Active Comparator: Insulin glargine||
Drug: insulin glargine
Insulin glargine injected subcutaneously (under the skin) once daily. The dose will be individually adjusted
Show 32 Study Locations
|Study Director:||Chris Lambert, B.S.Pharmacy||Novo Nordisk|