Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Diabetes Mellitus (DM) , diabetes, noninsulin-dependent diabetes mellitus (NIDDM), adult-onset diabetes, high blood sugar, T2DM
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 156
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study arm 2: In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Interventions: intervention 1: Vildagliptin (LAF237) intervention 2: Placebo intervention 3: Insulin intervention 4: Metformin
Intervention descriptions: intervention 1: Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily intervention 2: Matching placebo of vildagliptin 50 mg twice daily intervention 3: Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.

The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion. intervention 4: Patients continued their prescribed metformin dose, if applicable.

Protocol document: