FOR THE SITAGLIPTIN STUDY 021 GROUP*OBJECTIVE -To examine the efficacy and safety of once-daily oral sitagliptin as monotherapy in patients with type 2 diabetes. RESULTS -Sitagliptin 100 and 200 mg produced significant (P Ͻ 0.001) placebosubtracted reductions in A1C (Ϫ0.79 and Ϫ0.94%, respectively) and fasting plasma glucose (Ϫ1.0 mmol/l [Ϫ17.1 mg/dl] and Ϫ1.2 mmol/l [Ϫ21.3 mg/dl], respectively). Patients with baseline A1C Ն9% had greater reductions in placebo-subtracted A1C with sitagliptin 100 and 200 mg (Ϫ1.52 and Ϫ1.50%, respectively) than those with baseline A1C Ͻ8% (Ϫ0.57 and Ϫ0.65%) or Ն8 to Ͻ9.0% (Ϫ0.80 and Ϫ1.13%, respectively). In a meal tolerance test, sitagliptin 100 and 200 mg significantly decreased 2-h postprandial glucose (PPG) (placebo-subtracted PPG Ϫ2.6 mmol/l [Ϫ46.7 mg/dl] and Ϫ3.0 mmol/l [Ϫ54.1 mg/dl], respectively). Results for the above key efficacy parameters were not significantly different between sitagliptin doses. Homeostasis model assessment of ␤-cell function and proinsulin-to-insulin ratio improved with sitagliptin. The incidence of hypoglycemia was similar, and overall gastrointestinal adverse experiences were slightly higher with sitagliptin. No meaningful body weight changes from baseline were observed with sitagliptin 100 (Ϫ0.2 kg) or 200 mg (Ϫ0.1 kg). The body weight change with placebo (Ϫ1.1 kg) was significantly (P Ͻ 0.01) different from that observed with sitagliptin. RESEARCH DESIGN AND METHODSCONCLUSIONS -In this 24-week study, once-daily sitagliptin monotherapy improved glycemic control in the fasting and postprandial states, improved measures of ␤-cell function, and was well tolerated in patients with type 2 diabetes.

Sitagliptin monotherapy improved indices of glycemic control compared to placebo and was generally well-tolerated in patients with type 2 diabetes. The glycemic response to treatment with sitagliptin 100 mg/day was similar between the sitagliptin 100-mg once-daily and 50-mg twice-daily dose regimens.

No abstract

No abstract

No abstract