Conditions: Diabetes Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 362
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin aspart intervention 3: insulin detemir intervention 4: insulin aspart
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted. intervention 2: Administered s.c. with the remaining meals. Dose individually adjusted. intervention 3: Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing. intervention 4: Administered s.c. at meal-times. Dose individually adjusted.

Protocol document: