Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus

Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.

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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism*
  • Diabetes Mellitus, Type 2 / blood*
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Tolerance
  • Glycated Hemoglobin A / metabolism
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Hypoglycemic Agents / toxicity
  • Japan
  • Middle Aged
  • Patient Selection
  • Placebos
  • Pyrazines / therapeutic use*
  • Pyrazines / toxicity
  • Sitagliptin Phosphate
  • Triazoles / therapeutic use*
  • Triazoles / toxicity
  • Young Adult

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Placebos
  • Pyrazines
  • Triazoles
  • Sitagliptin Phosphate