Comparison of NN5401 versus insulin glargine, both with metformin treatment, in subjects with type 2 diabetes
Phase 3
Completed
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Diabetes Mellitus, Type 2
- Registration Number
- CTRI/2010/091/000044
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
Diagnosis of type 2 diabetes mellitus for at least 6 months
Insulin naïve subjects
Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
HbA1c between 7.5 ? 11.0% (both inclusive)
BMI (Body Mass Index) no higher than 40.0 kg/m2
Age 18 and older
Exclusion Criteria
Treatment with GLP-1 receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Cardiovascular disease diagnosed within 6 months before trial start
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c changeTimepoint: From baseline after 26 weeks of treatment<br>
- Secondary Outcome Measures
Name Time Method Plasma glucose profilesTimepoint: After 26 weeks of treatment<br>