Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00312104
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
Inclusion Criteria
- Type 1 diabetes for at least 12 months
- Current daily insulin dose of more than 1.4 IU/kg
- BMI lesser than or equal to 35 kg/m2
- HbA1c greater than 7.5% and less than or equal to 12.0%
- In Austria, age more than 19 years
Exclusion Criteria
- Proliferate retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Blood glucose Hypoglycaemia Adverse events Body weight
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇿🇦Cape Town, Western Cape, South Africa