Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 530
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin glargine
Intervention descriptions: intervention 1: Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted. intervention 2: Injected s.c. (under the skin) once daily. Dose was individually adjusted.

Protocol document: