Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride

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

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

Inclusion criteria

• 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

Exclusion criteria:

• 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