Conditions: Diabetes Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 629
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: insulin degludec intervention 2: insulin glargine intervention 3: insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously once daily. Dose was individually adjusted. intervention 2: Injected subcutaneously once daily. Dose individually adjusted. intervention 3: Injected subcutaneously as mealtime insulin. Dose was individually adjusted.

Protocol document: