Diabetes Mellitus, Type 2 Clinical Trial
Official title:
NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment/NN1250-3667: An Extension Trial to NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin ± OADs in Type 2 Diabetes (BEGIN™: BB)
This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).
The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin
glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without
pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the
long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with
or without metformin and with or without pioglitazone in subjects with type 2 diabetes.
All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial
participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.
Subjects who consent to participate in the extension trial (NN1250-3667) will continue to
receive the treatment to which they were randomly allocated in the 52 week trial
NN1250-3582.
The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension
period is registered as NN1250-3667.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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