Conditions: Diabetes Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 330
Healthy volunteers: no

Brief summary:
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.

Detailed description:

Arms:
arm 1: Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks arm 2: Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks

Interventions: intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin detemir
Intervention descriptions: intervention 1: NN304 injected s.c. (under the skin). Given as basal insulin. intervention 2: Injected s.c. (under the skin). Given as bolus insulin. intervention 3: NN729 injected s.c. (under the skin). Given as basal insulin

Protocol document: