Conditions: Diabetes Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 65
Healthy volunteers: no

Brief summary:
This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

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: The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime intervention 2: Injection subcutaneously at bedtime intervention 3: Injection subcutaneously immediately before each meal.

Protocol document: