Effects of Once-daily Sitagliptin on 24-h Glucose Control Following 4 Weeks of Treatment in Japanese Patients with Type 2 Diabetes Mellitus

 

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Abstract

The aim of the study was to assess the efficacy/safety of once- (100 mg q.d.) or twice-daily (50 mg b.i.d.) sitagliptin 100 mg/day in Japanese patients with type 2 diabetes (T2DM). In this randomized, double-blind study, 80 patients with inadequate glycemic control (HbA1c=6.5–10%; FPG ≤15.0 mmol/l) were randomized equally to sitagliptin 100 mg q.d., 50 mg b.i.d. or placebo for 4 weeks. At baseline and Week 4, frequent blood sampling was performed to assess 24-h weighted mean glucose (24-h WMG). Patients in the efficacy analyses (n=76) had a mean baseline HbA1c of 7.7%. At Week 4, least-squares mean changes in 24-h WMG were reduced with sitagliptin 100 mg q.d. and 50 mg b.i.d. versus placebo (−1.9, −1.6, and −0.5 mmol/l, respectively; p<0.001). Sitagliptin significantly improved FPG and 2-h PPG compared to placebo. No significant differences in 24-h WMG, FPG, or 2-h PPG were observed between the sitagliptin groups. Sitagliptin was well tolerated with no hypoglycemic events. In Japanese patients with T2DM, sitagliptin 100 mg/day provided substantial and continuous 24-h glucose-lowering over 4 weeks. The same glucose-lowering efficacy and tolerability were observed with sitagliptin 100 mg/day whether administered as a once-daily or twice-daily regimen. These results support a once-daily dosing regimen in Japanese patients with T2DM.

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These data were previously published as an abstract for the 67^th Scientific Session of the American Diabetes Association (ADA), June 22 – 26, 2007, and also presented at the 43^rd European Association for the Study of Diabetes (EASD), Sep 17 – 21, 2007.

Correspondence

K. Nonaka

Banyu Pharmaceutical Co., Ltd.

Clinical Development Institute

1-13-12 Kudan-kita

Kitanomaru Square

Chiyoda-ku

1028667 Tokyo

Japan

Phone: +81/3/6272 16 26

Fax: +81/3/6272 20 12

Email: yukako_fukao@merck.com