NCT02002221

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Vildagliptin (LAF237)	Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily
DRUG	Placebo	Matching placebo of vildagliptin 50 mg twice daily
DRUG	Insulin	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.
DRUG	Metformin	Patients continued their prescribed metformin dose, if applicable.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-12-05
• Last updated: 2016-03-01
• Results posted: 2016-03-01

Locations

31 sites across 1 country: Japan