Diabetes Clinical Trial
Official title:
NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, 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 in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)
This trial is conducted in Africa, Europe and the United States of America (USA).
The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue
(SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients
with type 1 diabetes.
The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension
period is registered as NN1250-3644.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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