Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00383877
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
Inclusion Criteria
- Type 2 diabetes
- HbA1C greater than 7.5% and less than or equal to 11.0%
- Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months
Exclusion Criteria
- Previous acute treatment with insulin for more than 7 days.
- Treatment with OAD(s) which does not adhere to the approval labeling.
- Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c after 20 weeks of treatment
- Secondary Outcome Measures
Name Time Method FBG after 20 weeks of treatment Safety profile during 20 weeks treatment Proportion of subjects achieving HbA1c less than or equal to 7.0% after 20 weeks of treatment Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial before breakfast during the trial at the end of the trial