A study to evaluate the effictiveness and safety of Vildagliptin in Subjects With Type 2 Diabetes.
Phase 2
Completed
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2
- Registration Number
- CTRI/2009/091/000134
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 452
Inclusion Criteria
?Patients at least 18 years of age at Visit 1
?Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
?HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
?Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1
Exclusion Criteria
?Pregnant or lactating female
?FPG ≥ 270 mg/dL (≥15 mmol/L)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeksTimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DMTimepoint: 24 weeks;Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeksTimepoint: 24 weeks;Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DMTimepoint: 76 weeks;Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DMTimepoint: 24 weeks