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Factors predicting therapeutic efficacy of combination treatment with sitagliptin and metformin in type 2 diabetic patients: the COSMETIC Study.

Author(s): Lim S, An JH, Shin H, Khang AR, Lee Y, Ahn HY, Yoon JW, Kang SM, Choi SH, Cho YM, Park KS, Jang HC

Affiliation(s): Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.

Publication date & source: 2011-09-29, Clin Endocrinol (Oxf)., [Epub ahead of print]

Objective: We assessed the predictive parameters for therapeutic efficacy of initial combination therapy with sitagliptin and metformin in drug-naive type 2 diabetic patients. Design, Patients and Measurements: In this 52-week treatment study, 150 patients (mean age, 54.9+/-12.5 years) with type 2 diabetes and HbA1c of 7.0-10% were treated with sitagliptin 100 mg once and metformin 500 mg twice daily. To assess the predictive parameters for therapeutic efficacy, a multivariate regression analysis was performed with baseline fasting glucose, insulin, C-peptide and glucagon levels, homeostasis model assessment-insulin resistance (HOMA-IR) and beta-cell function (HOMA-B), insulinogenic index (IGI, defined as 30-0 min insulin/30-0 min glucose), and area under the curve for glucose, insulin and C-peptide obtained after 75 gram oral glucose tolerance test. Results: After 52 weeks, mean HbA1c levels, and fasting and postload 2-h glucose were significantly decreased from 8.7+/-1.4 to 7.2+/-1.3%, 9.2+/-3.0 to 7.2+/-1.8 mmol/l, and 17.5+/-5.1 to 10.9+/-3.6 mmol/l, respectively (P <0.01). HOMA-B and IGI increased significantly from 50.3+/-33.5 to 75.1+/-32.8 and from 11.3+/-1.3 to 35.0+/-6.3 at 52 weeks, respectively (P <0.01). Multivariate regression analysis indicated that the reduction in HbA1c was significantly associated with high baseline HbA1c, low IGI, and short duration of diabetes after adjusting for age, sex, BMI, blood pressure, triglycerides, creatinine, hsCRP, glucagon, c-peptide, HOMA-B and HOMA-IR. No severe adverse events were observed. Conclusion: These results suggest that drug-naive type 2 diabetic patients with low beta-cell function would benefit the most from early initial combination therapy of sitagliptin and metformin (Clinical trial number: NCT00969566). Copyright (c) 2011 Blackwell Publishing Ltd.

Page last updated: 2011-12-09

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