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

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

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

Inclusion Criteria:

• Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
• C-peptide >0.6 ng/ml (>0.20 nmol/L).
• HbA1c ≥7.5 to ≤11% at Visit 1
• Treatment with stable, once or twice daily doses (maximum dose of < 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
• Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
• Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for participation in the study

• Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
• Pregnant or lactating women
• Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
• Current diagnosis of congestive heart failure (NYHA III or IV).
• Myocardial infarction (MI) within the past 6 months
• Liver disease such as cirrhosis or chronic active hepatitis

Other protocol defined inclusion/excusion criteria may apply