Conditions: Diabetes Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 456
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart.

The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: insulin degludec intervention 2: insulin detemir intervention 3: insulin aspart
Intervention descriptions: intervention 1: Injected s.c. (under the skin) once daily. Dose was individually adjusted. intervention 2: Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted. intervention 3: Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.

Protocol document: