Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01486940
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 598
Inclusion Criteria
- Type 1 diabetes for at least 12 months
- Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
- BMI below or equal to 35 kg/m^2
- HbA1c below or equal to 12%
Exclusion Criteria
- Proliferative retinopathy or maculopathy requiring acute treatment
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
- Subjects with known hypoglycaemic unawareness as judged by the Investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Basal/bolus regimen 2 insulin NPH - Basal/bolus regimen 2 human soluble insulin - Basal/bolus regimen 1 insulin aspart - Basal/bolus regimen 1 insulin detemir -
- Primary Outcome Measures
Name Time Method HbA1c (glycosylated haemoglobin)
- Secondary Outcome Measures
Name Time Method 8-point blood glucose profiles Incidence of self-recorded hypoglycaemic episodes Incidence of adverse events Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇪Falun, Sweden