Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 66
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/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: biphasic insulin aspart 30
Intervention descriptions: intervention 1: The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner. intervention 2: The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.

Protocol document: