Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00351884
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
Inclusion Criteria
- Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
- Body mass index in the range 22-40
- Blood glucose criteria must be met
Exclusion Criteria
- Pregnancy or lactation
- History of type 1 diabetes
- Evidence of significant diabetic complications
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - vildagliptin am Vildagliptin AM - vildagliptin pm vildagliptin pm -
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at 24 weeks 24 weeks
- Secondary Outcome Measures
Name Time Method Safety of vildagliptin in combination with metformin during 24 weeks of treatment 24 weeks Change from baseline in fasting plasma glucose at 24 weeks 24 weeks Patients with endpoint HbA1c < 7% after 24 weeks 24 weeks Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks 24 weeks Change from baseline in body weight at 24 weeks 24 weeks
Trial Locations
- Locations (2)
Novartis Investigative Site
🇩🇪Investigative Centers, Germany
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States