Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase‑4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care

OBJECTIVE — To assess the efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes and inadequate glycemic control on diet and exercise. RESEARCH DESIGN AND METHODS — In a 24-week, randomized, double-blind, placebo-controlled, parallel-group study, 1,091 patients with type 2 diabetes and A1C 7.5–11% were randomized to one of six daily treatments: sitagliptin 100 mg/metformin 1,000 mg (S100/ M1000 group), sitagliptin 100 mg/metformin 2,000 mg (S100/M2000 group), metformin 1,000 mg (M1000 group), metformin 2,000 mg (M2000 group) (all as divided doses administered twice daily [b.i.d.]), sitagliptin 100 mg q.d. (S100 group), or placebo. Patients who had an A1C 11 % or a fasting glucose value 280 mg/dl after the run-in period were not eligible to be randomized; these patients could participate in an open-label substudy and were treated with S100/M2000 for 24 weeks. RESULTS — The mean baseline A1C was 8.8 % in the randomized patients. The placebo-subtracted A1C change from baseline was 2.07 % (S100/M2000), 1.57 % (S100/M1000), 1.30 % (M2000),0.99 % (M1000), and0.83 % (S100) (P 0.001 for comparisons versus