Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Confirmed diagnosis of T2DM
On a stable dose of insulin as defined by the protocol
On a stable does of metformin (if applicable) as defined by the protocol
Age 18 to 80 years
HbA1c of 7.5 to 11.0%
Body Mass Index (BMI) 22 to 40 kg/m2
Type 1 diabetes
Short-acting or rapid-acting insulin
Pregnancy or lactation
Evidence of serious diabetic complications
Evidence of serious cardiovascular complications
Laboratory value abnormalities as defined by the protocol
Other protocol-defined inclusion/exclusion criteria may apply