Conditions: Diabetes Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 548
Healthy volunteers: no

Brief summary:
This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin detemir intervention 3: insulin aspart intervention 4: insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted. intervention 3: Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted. intervention 4: Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.

Protocol document: