Hermansen K et al. (2007) Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab 9: 733–745

A recently published study examined the effects of adding sitagliptin—an inhibitor of dipeptidyl peptidase 4—to therapy for patients with type 2 diabetes mellitus who were inadequately controlled on treatment with glimepiride alone or glimepiride in combination with metformin. A total of 441 patients (age range 18–75 years) were included in this multinational parallel-group study. Following a 2-week, single-blind placebo run-in period, patients entered a 24-week, double-blind, placebo-controlled treatment period. The study group consisted of stratum 1 (glimepiride alone, n = 212) and stratum 2 (glimepiride plus metformin, n = 229). Patients in each stratum were randomized to sitagliptin 100 mg once daily or placebo.

Sitagliptin significantly decreased HbA1c levels from baseline relative to placebo in the overall cohort as well as in each stratum. Treatment with sitagliptin also significantly increased the proportion of patients obtaining an HbA1c level of <7% in the overall study population and in stratum 2. The addition of sitagliptin significantly reduced fasting plasma glucose levels from baseline relative to placebo.

Sitagliptin was generally well tolerated, although the incidence of hypoglycemia was higher in patients taking the drug. A modest, but statistically significant weight gain was observed in patients on sitagliptin.

The authors conclude that sitagliptin is effective and well tolerated in patients with type 2 diabetes who are inadequately controlled on glimepiride or glimepiride plus metformin.