Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)

Multi-center, Open-label, 24-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin 50/500 or 50/1000 mg Twice Daily in Patients With T2DM Inadequately Controlled With Metformin

This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.

Inclusion Criteria:

• Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
• The patient is required to have HbA1c 6.5-11.0%
• BMI in the range of 22-48 kg/m2

Exclusion Criteria:

• Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%)
• Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
• Congestive heart failure requiring pharmacologic treatment
• Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
• Liver disease such as cirrhosis or chronic active hepatitis