Efficacy and safety of sitagliptin add-on therapy in Japanese patients with type 2 diabetes on insulin monotherapy
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ORIGINAL ARTICLE
Efficacy and safety of sitagliptin add-on therapy in Japanese patients with type 2 diabetes on insulin monotherapy Takashi Kadowaki • Naoko Tajima • Masato Odawara • Toshiomi Minamide • Masaru Kawashima • Daisuke Yanagida Taro Okamoto • Juan Camilo Arjona Ferreira
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Received: 21 August 2012 / Accepted: 17 February 2013 Ó The Japan Diabetes Society 2013
Abstract Introduction This multicenter, randomized study assessed the efficacy and safety of the dipeptidyl peptidase 4 inhibitor sitagliptin added to insulin monotherapy in Japanese patients with type 2 diabetes mellitus (T2DM). Materials and methods This study had an initial 16-week, double-blind treatment period in which 266 patients on diet/exercise and insulin monotherapy for C12 weeks were randomized (1:1) to sitagliptin 50 mg q.d. (N = 129; mean baseline HbA1c = 8.9 %) or placebo (N = 137; mean baseline HbA1c = 8.9 %). It was followed by a 36-week, open-label treatment period in which all patients received sitagliptin 50 mg q.d., which could have been increased to 100 mg q.d. for patients meeting predefined glycemic criteria.
Portions of this research were presented at the American Diabetes Association 71st Scientific Sessions, 24-28 June 2011, San Diego, CA, USA. This study is registered in ClinicalTrials.gov: NCT00854035, ‘‘A Phase III, Randomized, Placebo-Controlled, Double-Blind Clinical Trial and Subsequent Open-Label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of MK-0431/ONO-5435 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Insulin Monotherapy’’, http://clinicaltrials.gov/ct2/show/NCT00854035. T. Kadowaki Department of Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan N. Tajima Jikei University School of Medicine, Tokyo, Japan M. Odawara The Third Department of Internal Medicine, Tokyo Medical University, Tokyo, Japan
Results After 16 weeks, treatment with sitagliptin resulted in significant placebo-adjusted mean decreases from baseline in HbA1c, fasting plasma glucose, and 2-h postmeal glucose of -0.9 % (p \ 0.001), -11.4 mg/dl (p = 0.007), and -39.9 mg/dl (p \ 0.001), respectively. During the double-blind period, adverse experiences (AEs) were reported with similar frequency in both treatment groups and the incidence of gastrointestinal AEs was low. The incidence of hypoglycemia AEs in the sitagliptin group (20.2 %) was higher than in the placebo group (12.4 %), but the between-group difference was not statistically significant (p = 0.097). Small increases from baseline in body weight were observed with sitagliptin [sitagliptin: 0.6 kg (p \ 0.001), placebo: 0.1 kg (p = 0.498)]. In the openlabel period, sustained improvements in glycemic parameters were observed with sitagliptin treatment, and sitagliptin was generally well tolerated. Conclusions In Japanese patients with T2DM inadequately controlled on insulin monotherapy, the addition of sitagliptin provided significant improvements in glycemic
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