Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Phase 2
Completed
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2009/091/000126
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
?Patients 18-78 years old inclusive at Visit 1
?T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit
?Patient agreement to maintain same dose of metformin throughout study
?HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
?Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1
Exclusion Criteria
?Pregnant or nursing (lactating) women
?FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Timepoint:
- Secondary Outcome Measures
Name Time Method