Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride (Vildagliptin)
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A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs) [ Time Frame: 24 weeks ]
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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 by standard criteria.
Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
Age: ≥18 to ≤ 80 years
HbA1c of ≥ 7.5 and ≤ 11.0%
Body Mass Index (BMI) ≥22 to ≤45 kg/m2
FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply