Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus

Endocrine Journal

Kenji Nonaka³  Yasuhiko Iwamoto¹  Juan Camilo Arjona Ferreira²  Tadaaki Taniguchi³  John Amatruda²  Taro Okamoto³  Kotoba Okuyama³ 

[1] Diabetes Center, Tokyo Women’s Medical University, Tokyo, Japan;Merck & Co., Inc., Rahway, NJ, United States;Banyu Pharmaceutical Co., LTD., Tokyo, Japan

关键词: Glycemic control;    DPP-4 inhibitor;    MK-0431;    Incretins;   

DOI  :  10.1507/endocrj.K09E-272

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

References(19)Cited-By(43)Sitagliptin is an oral, potent, highly selective, once-daily DPP-4 inhibitor indicated for the treatment of type 2 diabetes mellitus (T2DM). To assess the dose-ranging efficacy and safety/tolerability profile of once-daily sitagliptin 25, 50, 100, and 200 mg in Japanese patients with T2DM. In this randomized, double-blind, placebo-controlled study, 363 Japanese patients with inadequate glycemic control (HbA1c=6.5-10%; FPG≤270 mg/dL) were randomized (1:1:1:1:1) to placebo, sitagliptin 25, 50, 100, or 200 mg q.d. for 12 weeks. The primary endpoint was change from baseline in HbA1c at Week 12. At Week 12, treatment with sitagliptin at all doses tested provided significant (p<0.001) reductions in HbA1c (-0.69 to -1.04%) from baseline (7.49 to 7.65%) relative to placebo. Sitagliptin significantly (p<0.001) reduced fasting plasma glucose (FPG; -15.9 to -23.2 mg/dL) and 2-hour postprandial glucose (2-hr PPG; -40.3 to -65.0 mg/dL) relative to placebo, in a dose-dependent manner. At doses ≥50 mg, differences in HbA1c, FPG, and 2-hr PPG between the sitagliptin groups were not statistically significant. Sitagliptin was generally well tolerated with a low and similar incidence of hypoglycemia and minimal weight gain relative to placebo. Treatment with sitagliptin for 12 weeks provided significant and clinically meaningful reductions in HbA1c, FPG, and 2-hr PPG across the dose range studied and was generally well tolerated in Japanese patients with T2DM.

【 授权许可】

Unknown