Improved glycaemic control with vildagliptin added to insulin, with or without metformin, in patients with type 2 diabetes mellitus. Issue 3 (1st November 2012)

• Record Type: Journal Article
• Authors: Kothny, W.; Foley, J.; Kozlovski, P.; Shao, Q.; Gallwitz, B.; Lukashevich, V.
• Is Part Of: Diabetes, obesity & metabolism. Volume 15:Issue 3(2013:Mar.)
• Page Start: 252
• Page End: 257
• Publication Date: 2012-11-01
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12020
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12020-sec-0001" sec-type="section"> <title>Aim</title> <p>The aim of this study is to assess the efficacy and safety of vildagliptin 50 mg bid as add‐on therapy to insulin in type 2 diabetes mellitus (T2DM).</p> </sec> <sec id="dom12020-sec-0002" sec-type="section"> <title>Methods</title> <p>This is a multicentre, double‐blind, placebo‐controlled, parallel group, clinical trial in T2DM patients inadequately controlled by stable insulin therapy, with or without metformin. Patients received treatment with vildagliptin 50 mg bid or placebo for 24 weeks.</p> </sec> <sec id="dom12020-sec-0003" sec-type="section"> <title>Results</title> <p>In all, 449 patients were randomized to vildagliptin (n = 228) or placebo (n = 221). After 24 weeks, the difference in adjusted mean change in haemoglobin A1c (HbA1c) between vildagliptin and placebo was −0.7 ± 0.1% (p < 0.001) in the overall study population, −0.6 ± 0.1% (p < 0.001) in the subgroup also receiving metformin and −0.8 ± 0.2% (p < 0.001) in the subgroup without metformin. Vildagliptin therapy was well tolerated and had a similarly low incidence of hypoglycaemia compared with placebo (8.4 vs. 7.2%, p = 0.66) in spite of improved glycaemic control, and was not associated with weight gain. (+0.1 vs. −0.4 kg).</p> </sec> <sec id="dom12020-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Vildagliptin 50 mg bid added to insulin significantly reduced HbA1c in patients with T2DM inadequately controlled by insulin, with or without metformin. Vildagliptin was well tolerated, with a safety profile similar to placebo. These results were achieved without weight gain or an increase in hypoglycaemia incidence or severity in spite of improved glycaemic control.</p> </sec> </abstract>