Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin in Patients With Type 2 Diabetes
- Registration Number
- NCT01356381
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to placebo on insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) treated with metformin, assessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic euglycemic clamp.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- Age in the range of 18-70 years.
- Patients with T2DM, diagnosed at least 6 months prior to Visit 1, who have received metformin for at least 3 months and have been on a stable dose of at least 1000mg daily for a minimum of 4 weeks prior to Visit 1.
- HbA1c ≤ 7.6% at Visit 1.
- Body mass index (BMI) in the range of 22-38kg/m2 inclusive at Visit 1.
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Exclusion Criteria
- Pregnant or nursing (lactating) women.
- Patients with cardiac pacemakers or with metallic implants incompatible with magnetic resonance methodology.
- Congestive heart failure requiring pharmacologic treatment. Other protocol-defined inclusion/exclusion criteria may apply.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - vildagliptin Vildagliptin -
- Primary Outcome Measures
Name Time Method Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal). 24 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Newcastle Upon Tyne, United Kingdom