A trial to study the efficacy and safety of PDM011011 capsules in comparison with metformin in type 2 diabetic patients.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Type 2 diabetes mellitus
- Registration Number
- CTRI/2013/01/003308
- Lead Sponsor
- Piramal Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Type 2 diabetic patients with an HbA1c between 7 to 10% and fasting plasma glucose between 110 mg/dl and 250 mg/dl.
Exclusion Criteria
Patients of type 1 diabetes, secondary diabetes mellitus, pregnany or lactating women, with any other clinically significant abnormalities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in fasting plasma glucose between active and comparator groupsTimepoint: Baseline and week 15
- Secondary Outcome Measures
Name Time Method Mean change in HbA1c between active and comparator groupsTimepoint: Baseline and week 15