Efficacy and Safety of Insulin Detemir in Type 1 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00595374
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe.
The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
- Duration of type 1 diabetes for at least 12 months
- BMI below 35 kg/m2
- HbA1c between 7.0-12.0%
- Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
- Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator
Exclusion Criteria
- Known or suspected allergy to trial product or related products
- Previous participation in this trial
- Receipt of any investigational products within the last 2 months prior to this trial
- Drug or alcohol dependence
- Pregnancy, breast-feeding or intention of becoming pregnant
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 Incidence of hypoglycaemic episodes Plasma glucose profiles Change in body weight Quality of Life Incidence of adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇳🇱Zwolle, Netherlands