Study to determine the durability of glycaemic control with early treatment with a vildagliptin–metformin combination regimen vs. standard‐of‐care metformin monotherapy—the VERIFY trial: a randomized double‐blind trial. Issue 10 (17th July 2014)

• Record Type: Journal Article
• Authors: Del Prato, S.; Foley, J. E.; Kothny, W.; Kozlovski, P.; Stumvoll, M.; Paldánius, P. M.; Matthews, D. R.
• Is Part Of: Diabetic medicine. Volume 31:Issue 10(2014:Oct.)
• Page Start: 1178
• Page End: 1184
• Publication Date: 2014-07-17
• Subjects: Diabetes -- Periodicals; 616.462
• DOI: 10.1111/dme.12508
• Languages: English
• ISSNs: 0742-3071

Abstract

<abstract abstract-type="main" id="dme12508-abs-0001"> <title>Abstract</title> <sec id="dme12508-sec-0001" sec-type="section"> <title>Aims</title> <p>Durability of good glycaemic control (HbA<sub>1c</sub>) is of importance as it can be the foundation for delaying diabetic complications. It has been hypothesized that early initiation of treatment with the combination of oral anti‐diabetes agents with complementary mechanisms of action can increase the durability of glycaemic control compared with metformin monotherapy followed by a stepwise addition of oral agents. Dipeptidyl peptidase‐4 inhibitors are good candidates for early use as they are efficacious in combination with metformin, show weight neutrality and a low risk of hypoglycaemia. We aimed to test the hypothesis that early combined treatment of metformin and vildagliptin slows β‐cell deterioration as measured by HbA<sub>1c</sub>.</p> </sec> <sec id="dme12508-sec-0002" sec-type="section"> <title>Methods</title> <p>Approximately 2000 people with Type 2 diabetes mellitus who were drug‐naive or who were treated with metformin for less than 1 month, and who have HbA<sub>1c</sub> of 48–58 mmol/mol (6.5–7.5%), will be randomized in a 1:1 ratio in VERIFY, a 5‐year multinational, double‐blind, parallel‐group study designed to compare early initiation of a vildagliptin–metformin combination with standard‐of‐care initiation of metformin monotherapy, followed by the stepwise addition of vildagliptin when glycaemia deteriorates. Further deterioration will be treated with insulin. The primary analysis for treatment failure will be from a Cox proportional hazard regression model and the durability of glycaemic control will be evaluated by assessing treatment failure rate and the rate of loss in glycaemic control over time as co‐primary endpoints.</p> </sec> <sec id="dme12508-sec-0003" sec-type="section"> <title>Summary</title> <p>VERIFY is the first study to investigate the long‐term clinical benefits of early combination treatment vs. the standard‐of‐care metformin monotherapy with a second agent added by threshold criteria.</p> </sec> </abstract>