drugset / Trial / NCT01582230

Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

NCT01582230 ↗

Phase 3 Completed 293 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

Timeline

Start
2012-04
Primary completion
2013-05
Completion
2013-05

Outcome

Met primary endpoint

paper The adjusted mean (±SE) change in HbA1c at Week 24 in the vildagliptin and placebo groups was -1.08 ± 0.12% and -0.38 ± 0.12%, respectively (between-treatment difference -0.70 ± 0.16%; P < 0.001). PMID 25929739 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified 50 mg —