Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)
This trial will be conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare NN1250 with insulin glargine in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.
|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 NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)|
- HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Body weight change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
NN1250 will be injected subcutaneously (under the skin) three times weekly. The dose will be individually adjusted.
|Active Comparator: B||
Drug: insulin glargine
Insulin glargine will be injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
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|Study Director:||Dorthe Lyngsoe Vuylsteke||Novo Nordisk|