Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
Phase 3
Completed
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2010/091/001276
- Lead Sponsor
- ovartis HeatlhCare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 428
Inclusion Criteria
Confirmed diagnosis of T2DM
On a stable dose of insulin as defined by the protocol
On a stable does of metformin (if applicable) as defined by the protocol
Age 18 to 80 years
HbA1c of 7.5 to 11.0percentage
Body Mass Index (BMI) 22 to 40 kg per m2
Exclusion Criteria
Type 1 diabetes.
Short-acting or rapid-acting insulin.
Pregnancy or lactation.
Evidence of serious diabetic complications.
Evidence of serious cardiovascular complications.
Laboratory value abnormalities as defined by the protocol.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c reductionTimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method HbA1c reduction in subpopulation treated with insulin and without metforminTimepoint: 24 weeks;Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)Timepoint: 24 weeks;Reduction in FPG (overall and subpopulations)Timepoint: 24 weeks;Responder rates (overall and subpopulations)Timepoint: 24 weeks;HbA1c reduction in subpopulation treated with insulin and with metforminTimepoint: 24 weeks