drugset / Trial / NCT01233622

Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride

NCT01233622 ↗

Phase 3 Completed 317 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

Timeline

Start
2010-10
Primary completion
2011-11
Completion
2011-11

Outcome

Met primary endpoint

paper haemoglobin A1c (HbA1c) was -1.01% with vildagliptin (baseline 8.75%) and -0.25% with placebo (baseline 8.80%), with a between-treatment difference of -0.76% (p < 0.001). PMID 24199686 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified 50 mg —