Poster Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2014

Vildagliptin Efficacy in combination with metfoRmIn For earlY treatment of type 2 diabetes mellitus (VERIFY) (#315)

Stefano Del Prato 1 , James E. Foley 2 , Wolfgang Kothny 3 , Plamen Kozlovski 3 , Päivi M. Paldánius 3 , Michael Stumvoll 4 , David R. Matthews 5
  1. University of Pisa, Pisa, Italy
  2. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA
  3. Novartis Pharma AG, Basel, Switzerland
  4. Department of Medicine, University of Leipzig, Leipzig, Germany
  5. Oxford Centre for Diabetes Endocrinology & Metabolism, University of Oxford, Oxford, UK

Durability of good glycaemic control may delay the development of diabetic complications in patients with type 2 diabetes mellitus (T2DM). Early initiation of combination treatment with oral anti-diabetic drugs (OADs) that have complementary mechanisms of action may increase the durability of glycaemic control compared with the stepwise addition of OADs. Dipeptidyl peptidase-4 (DPP-4) inhibitors such as vildagliptin are good candidates for early use in combination with metformin, as they are weight neutral with no additional risk of hypoglycaemia.

In VERIFY, a five-year, multinational, double-blind, parallel-group study, about 2000 drug-naïve patients with T2DM and HbA1c between 6.5%–7.5% will be randomised to receive either vildagliptin/metformin or metformin alone. The study will test the hypothesis whether early combination therapy with vildagliptin/metformin will result in lower treatment failure rate or in lower rate of loss in glycaemic control over time than with metformin alone. Other objectives include evaluation of rate of fasting plasma glucose progression, change in HbA1c over time, time to insulin initiation, development/progression of diabetic complications, changes in body weight, changes in HOMA-beta/IR, safety, and tolerability. Insulin secretion rate and insulin sensitivity will be assessed in annual standard meal-tests. Participants will also be evaluated for early changes in the vasculature, microalbuminuria and retinal microaneurysms.

VERIFY is the first study to investigate the long-term clinical benefits of early combination treatment versus the current standard-of-care, metformin, followed by addition of OADs. VERIFY will provide valuable data on the durability of glycaemic control, beta–cell function, insulin resistance, safety and tolerability, and will explore early changes in the vasculature of people with T2DM. Study is expected to complete in 2019.