drugset / Trial / NCT01541956

Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)

NCT01541956 ↗

Phase 4 Completed 3091 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.

Timeline

Start
2012-02
Primary completion
2013-12
Completion
2013-12

Outcome

Met primary endpoint

paper HbA1c reduction of 0.54% at week 24 in the VLDM group was non-inferior and statistically superior compared with 0.40% in the HDM group PMID 27406394 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg —
Subject Metformin Small molecule 1000 mg —
Subject Vildagliptin Other / unclassified 50 mg —