Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

A 12-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Equa (Vildagliptin) 50 mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

Inclusion Criteria:

• Confirmed diagnosis of T2DM by standard criteria.
• HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
• Age: ≥ 20 to < 75 years old at Visit 1.
• BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

Exclusion Criteria:

• FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.
• Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
• Significant heart diseases
• Hepatic disorder

Other protocol defined inclusion/exclusion criteria may apply