Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

Phase 3 Completed 431 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).

Timeline

Start: 2010-12
Primary completion: 2012-03
Completion: 2012-03

Outcome

Met primary endpoint

paper 72 (52·6%) of 137 patients achieved their target in the vildagliptin group (adjusted odds ratio 3·16, 96·2% CI 1·81-5·52; p<0·0001). PMID 23706759 ↗

Publications

Strain WD, Lukashevich V, Kothny W, Hoellinger MJ, Paldanius PM. Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study. Lancet. 2013 Aug 3;382(9890):409-416. doi: 10.1016/S0140-6736(13)60995-2. Epub 2013 May 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vildagliptin	Other / unclassified	50 mg	—