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Effect of Initial Combination Therapy with Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients with Type 2 Diabetes

¹Jefferson Medical College, Philadelphia, PA, USA
²Duke University Medical Center, Durham, NC, USA
³Merck Research Laboratories, Rahway, NJ, USA

debora_williamsherman{at}merck.com

ABSTRACT

Objective:To assess the efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes (T2DM) and inadequate glycemic control on diet and exercise.

Research Design and Methods:In a 24-week, randomized, double-blind, placebo-controlled, parallel-group study, 1091 patients with T2DM and HbA_1c 7.5% to 11% were randomized to one of six daily treatments: sitagliptin 100-mg/metformin 1000-mg (S100/M1000), sitagliptin 100-mg/metformin 2000-mg (S100/M2000), metformin 1000-mg (M1000), metformin 2000-mg (M2000) (all as divided doses administered b.i.d.), sitagliptin 100-mg q.d. (S100), or placebo. Patients who had an HbA_1c >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 sub-study and were treated with S100/M2000 for 24 weeks.

Results:The mean baseline HbA_1c was 8.8% in the randomized patients. The placebo-subtracted HbA_1c change from baseline was -2.07% (S100/M2000), -1.57% (S100/M1000), -1.30% (M2000), -0.99% (M1000), and -0.83% (S100) (p<0.001 for comparisons vs. placebo and for co-administration vs. respective monotherapies). The proportion of patients achieving an HbA_1c <7% and <6.5% was 66% and 44%, respectively, in the S100/M2000 group (p<0.001 vs. S100 or M2000). For the open-label cohort (n=117; baseline HbA_1c=11.2%) treated with S100/M2000, the within-group mean HbA_1c change from baseline was -2.9%. The incidence of hypoglycemia was low (0.5%-2.2%) across active treatment groups and not significantly different from placebo (0.6%). The incidence of gastrointestinal adverse experiences was similar for co-administration therapies compared with their respective metformin monotherapy.

Conclusions:The initial combination of sitagliptin and metformin provided substantial and additive glycemic improvement and was generally well-tolerated in patients with T2DM.

Clinicaltrials.gov: NCT00103857

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