Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin in Patients With Type 2 Diabetes
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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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Single-center,Double-blind,Randomised,Placebo-controlled,Parallel-group Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin on Insulin Sensitivity and Its Underlying Mechanism in Patients With T2DM Treated With Metformin
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.