Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00184665
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
Inclusion Criteria
- Type 1 diabetes
- Currently on basal-bolus regimen
- BMI = 35.0 kg/m2
- HbA1c =11.0%
Exclusion Criteria
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Cardial problems
- Uncontrolled hypertension
- Impaired hepatic or renal function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after a two-year trial period
- Secondary Outcome Measures
Name Time Method Body composition Blood glucose Body weight Antibodies Adverse events Hypoglycaemia
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇹🇷Istanbul, Turkey