At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Vildagliptin (LAF237), Placebo, and 2 other interventions for Type 2 Diabetes Mellitus (T2DM). Completed, enrolled 156 participants across 31 sites.
Detailed 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.
Study Details
Timeline
Interventions
Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily
Matching placebo of vildagliptin 50 mg twice daily
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.
Patients continued their prescribed metformin dose, if applicable.