Conditions: Diabetes Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 23
Healthy volunteers: no

Brief summary:
This trial is conducted in Europe. The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.

Detailed description:
The study had been temporarily halted due to an unplanned interim analysis. The Sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study

Arms:
arm 1: Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart arm 2: Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart

Interventions: intervention 1: insulin detemir intervention 2: insulin NPH intervention 3: insulin aspart
Intervention descriptions: intervention 1: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection intervention 2: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection intervention 3: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection

Protocol document: