Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00604396
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe.
The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 477
Inclusion Criteria
- Type 2 diabetes for at least 12 months since diagnosis
- Insulin naive subjects
- OAD treatment for at least 4 months alone or combined with no more than two OADs
- Body mass index (BMI) below 35.0 kg/m2
- HbA1c between 7.5-10.0%
- Able and willing to use twice a day injections for the entire trial period
Exclusion Criteria
- Current or previous treatment with thiazolidiones within the last 6 months
- OAD treatment with three or more OADs within the last 6 months
- Acute insulin treatment for longer than 7 days in a row within the last 6 months
- Secondary diabetes
- Known maturity onset of diabetes of young (MODY)
- Known or suspected allergy to trial product or related products
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 total hypoglycaemic episodes Body weight Incidence of adverse events Insulin antibodies Fasting plasma glucose Within-subject variation
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇪Umeå, Sweden