A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2012/06/002737
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 2000
•Type 2 Diabetes Mellitus (T2DM) diagnosed lesser than equal to 24 months ago
•glycosylated hemoglobin (HbA1c) greater than or equal to 6.5percent and lesser than equal to 7.5percent at Visit 1
•Treatment-naïve.
•Body mass index (BMI) greater than or equal to 22 and lesser than equal to 40 kg per m2 at Visit 1
•Pregnant or nursing (lactating) women
•Fasting plasma glucose (FPG) greater than equal to 270 mg per dL (greater than equal to 15.0 mmolper L)
•Previous or current participation in any vildagliptin clinical study.
•History of hypersensitivity to dipeptidyl peptidase-4 (DPP-4) inhibitors.
•Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
•Donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Rate of loss in glycemic control over time <br/ ><br>2.Time to initial treatment failureTimepoint: 1.Rate of loss in glycemic control over time <br/ ><br>2.Time to initial treatment failure
- Secondary Outcome Measures
Name Time Method 1.Rate of loss in glycemic control in fasting plasma glucose <br/ ><br>2.Rate of loss in glycemic control in fasting plasma glucose (FPG) during period 2 3.Rate of loss of beta cell function from baseline to end of study ( 5 years) <br/ ><br>4.Number patients with adverse events, death and serious adverse events <br/ ><br>5.Rate of loss in glycemic control in over time <br/ ><br>6.Rate of change in insulin sensitivity from baseline to end of study (5 years)Timepoint: 1.UP to 5 years <br/ ><br>2.Up to 5 years <br/ ><br>3.From baseline to end of study (5 years) <br/ ><br>4.5 years <br/ ><br>5.Up to 5 years <br/ ><br>6.From baseline to end of study (5 years)