Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of the vision studyReport as inadecuate




Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of the vision study - Download this document for free, or read online. Document in PDF available to download.

Cardiovascular Diabetology

, 12:118

First Online: 19 August 2013Received: 02 May 2013Accepted: 13 August 2013

Abstract

Background and aimLimitations of the currently recommended stepwise treatment pathway for type 2 diabetes mellitus T2DM, especially the failure of monotherapies to maintain good glycemic control, have prompted use of early, more aggressive combination therapies.

The VISION study is designed to explore the efficacy and safety of vildagliptin as an add-on to metformin therapy compared with up-titration of metformin monotherapy in Chinese patients with T2DM.

MethodsVISION, a 24-week, phase 4, prospective, randomized, multicenter, open-label, parallel-group study, will include 3312 Chinese T2DM patients aged ≥18 years who are inadequately controlled 6.5% >HbA1c ≤9% by metformin 750–1000 mg-day. Eligible patients will be randomized to receive either vildagliptin plus metformin or up-titration of metformin monotherapy 5:1. Patients will also be subgrouped 1:1:1:1 based on their age and body mass index BMI: <60 years and <24 kg-m; <60 years and ≥24 kg-m; ≥60 years and <24 kg-m; and ≥60 years and ≥24 kg-m.

ConclusionThe VISION study will test the hypothesis that early use of combination therapy with vildagliptin and metformin will provide good glycemic control and will be better tolerated than up-titration of metformin monotherapy. The study will also correlate these benefits with age and BMI.

KeywordsVISION study Vildagliptin Type 2 diabetes Study design DPP-IV inhibitors AbbreviationsAEAdverse event

ANCOVAAnalysis of covariance

BMIBody mass index

DPP-IVDipeptidyl peptidase IV

FASFull analysis set

FPGFasting plasma glucose

GIGastrointestinal

GIPGlucose-dependent insulinotropic polypeptide

GLP-1Glucagon-like peptide-1

HbA1cGlycated hemoglobin

IDFInternational Diabetes Federation

ITTIntention-to-treat

LOCFLast observation carried forward

PPGPostprandial plasma glucose

PPSPer-protocol set

SASSafety analysis set

T2DMType 2 diabetes mellitus

UKPDSUnited Kingdom Prospective Diabetes Study

WHOWorld Health Organization.

Electronic supplementary materialThe online version of this article doi:10.1186-1475-2840-12-118 contains supplementary material, which is available to authorized users.

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Author: Li-Nong Ji - Chang-Yu Pan - Ju-Ming Lu - Hong Li - Qiang Li - Qi-Fu Li - Yong-De Peng - Hao-Ming Tian - Chen Yao - Zhi-Ga

Source: https://link.springer.com/article/10.1186/1475-2840-12-118







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