Brief Article
Copyright ©2013 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Diabetes. Aug 15, 2013; 4(4): 151-156
Published online Aug 15, 2013. doi: 10.4239/wjd.v4.i4.151
Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes
Plamen Kozlovski, James Foley, Qing Shao, Valentina Lukashevich, Wolfgang Kothny
Plamen Kozlovski, Novartis Pharma AG, CH-4002 Basel, Switzerland
James Foley, Qing Shao, Valentina Lukashevich, Wolfgang Kothny, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, United States
Author contributions: Kozlovski P drafted the manuscript and was critical to conducting the trial, initial data interpretation and overall clinical interpretation; Kothny W contributed to study design, initial data interpretation and overall clinical interpretation; Lukashevich V was critical to designing and conducting the trial, data collection and initial data interpretation; Shao Q was responsible for the statistical analysis; Foley J contributed to the overall data interpretation; all authors were involved in manuscript revisions and are responsible for intellectual content.
Supported by Novartis Pharma AG
Correspondence to: Plamen Kozlovski, MD, Novartis Pharma AG, CH-4002 Basel, Switzerland. plamen.kozlovski@novartis.com
Telephone: +41-61-6964697 Fax: +41-61-3247921
Received: March 28, 2013
Revised: May 11, 2013
Accepted: June 18, 2013
Published online: August 15, 2013
Processing time: 139 Days and 17.7 Hours
Abstract

AIM: To assess the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to insulin in Asian patients with type 2 diabetes mellitus (T2DM).

METHODS: This was a post hoc analysis of a subgroup of Asian patients from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in T2DM patients inadequately controlled by stable insulin therapy, with or without metformin. A total of 173 patients were randomized 1:1 to receive treatment with vildagliptin 50 mg bid (n = 87) or placebo (n = 86) for 24 wk. Changes in HbA1c and fasting plasma glucose (FPG), from baseline to study endpoint, were analyzed using an analysis of covariance model. Change from baseline to endpoint in body weight was summarized by treatment. Safety and tolerability of vildagliptin was also evaluated.

RESULTS: After 24 wk, the difference in adjusted mean change in HbA1c between vildagliptin and placebo was 0.82% (8.96 mmol/mol; P < 0.001) in Asian subgroup, 0.85% (9.29 mmol/mol; P < 0.001) in patients also receiving metformin, and 0.73% (7.98 mmol/mol; P < 0.001) in patients without metformin, all in favor of vildagliptin. There was no significant difference in the change in FPG between treatments. Weight was stable in both treatment groups (+ 0.3 kg and -0.2 kg, for vildagliptin and placebo, respectively). Overall, vildagliptin was safe and well tolerated with similarly low incidences of hypoglycemia (8.0% vs 8.1%) and no severe hypoglycemic events were experienced in either group.

CONCLUSION: In Asian patients inadequately controlled with insulin (with or without concomitant metformin), insulin-vildagliptin combination treatment significantly reduced HbA1c compared with placebo, without an increase in risk of hypoglycemia or weight gain.

Keywords: Asian; DPP-4 inhibitor; Hypoglycemia; Insulin; Oral antidiabetic drug; Type 2 diabetes; Vildagliptin

Core tip: In Asian patients, vildagliptin added to stable dose of insulin, with or without concomitant metformin, significantly improves glycemic control without increase in weight and hypoglycemia incidence.