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

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.

Timeline

Start

2013-12

Primary completion

2015-02

Completion

2015-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Vildagliptin (LAF237) vs Placebo; p < 0.001; Mean Difference (Net) -0.91 (95% CI -1.08 to -0.73); ANCOVA NCT02002221 ↗

paper Addition of vildagliptin resulted in statistically significant reductions in HbA1c after 12 weeks (-1.01 ± 0.06%), with a between-treatment difference of -0.91 ± 0.09% (p < 0.001). PMID 26620049 ↗

Publications

• Hirose T, Suzuki M, Tsumiyama I. Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study. Diabetes Ther. 2015 Dec;6(4):559-571. doi: 10.1007/s13300-015-0147-6. Epub 2015 Nov 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vildagliptin	Other / unclassified	50 mg	—
Background	Insulin	Protein / enzyme biologic	—	—
Background	Metformin	Small molecule	—	—

Indications