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A 32-week National, Single-centre, Open-labelled, Randomised, Crossover Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-Bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
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.
Details
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 23 |
| Start date | 2007-07 |
| Completion | 2008-07 |
Conditions
- Diabetes
- Diabetes Mellitus, Type 1
Interventions
- insulin detemir
- insulin NPH
- insulin aspart
Primary outcomes
- Total Energy Expenditure, Double-labelled Water Method — Weeks 14-16, weeks 30-32
Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure. - Total Energy Expenditure, Dietary Record Method — Weeks 14-16, weeks 30-32
The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE.
Countries
United Kingdom