Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 881
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.

Detailed description:

Arms:
arm 1: Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication. arm 2: Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.

Interventions: intervention 1: Faster-acting insulin aspart intervention 2: Insulin aspart intervention 3: Insulin glargine
Intervention descriptions: intervention 1: Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted. intervention 2: Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted. intervention 3: Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

Protocol document: