Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00592527
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Asia.
The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
- Type 2 diabetes for at least 12 months since diagnosis
- Insulin naive subjects
- OAD treatment for at least 4 months with max. two OAD treatments
- Body mass index below 30.0 kg/m2
- HbA1c between 7.0-11.0%
Exclusion Criteria
- OAD treatment with three or more OADs
- Secondary diabetes
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
- Uncontrolled hypertension
- Known or suspected allergy to trial product or related products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method HbA1c after 20 weeks of treatment
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose (FPG) Within-subject variation Change in body weight Incidence of adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇳Nagpur, India
Novo Nordisk Investigational Site🇮🇳Nagpur, India