Efficacy and Safety of the Dipeptidyl Peptidase-4 Inhibitor Alogliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control: A Randomized, Double-Blind, Placebo-Controlled Study

Abstract

Objective: Evaluate the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin in drug-naïve patients with inadequately controlled type 2 diabetes.

Research design and methods: This double-blind, placebo-controlled, multicenter study included 329 poorly controlled patients randomized to once-daily treatment with alogliptin 12.5 mg (n=133), alogliptin 25 mg (n=131), or placebo (n=65) for 26 weeks. Primary efficacy end point was mean change from baseline in glycosylated hemoglobin (A1C) at final visit.

Results: At week 26, mean change in A1C was significantly greater (P < 0.001) for alogliptin 12.5 mg (-0.56%) and 25 mg (-0.59%) than placebo (-0.02%). Reductions in fasting plasma glucose also were greater (P < 0.001) in alogliptin-treated patients than in those receiving placebo. Overall incidences of adverse events (67.4%–70.3%) and hypoglycemia (1.5%–3.0%) were similar across treatment groups.

Conclusions: Alogliptin monotherapy was well tolerated and significantly improved glycemic control in patients with type 2 diabetes, without raising the incidence of hypoglycemia.