Effect of Initial Combination Therapy With Sitagliptin, and Metformin on Glycemic Control in Patients With Type 2 Diabetes

<p>The objective was To assess the efficacy and safety of initial combination therapy with sitagliptin(a Dipeptidyl Peptidase-4 Inhibitor) and metformin in patients with type 2 diabetes and inadequate glycemic control on diet and exercise. </p>
<p>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 &gt;11% or a fasting glucose value &gt;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. </p>
<p>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), and –0.83% (S100) (P &lt; 0.001 for comparisons versus placebo and for coadministration versus respective monotherapies). The proportion of patients achieving an A1C &lt;7% and &lt;6.5% was 66 and 44%, respectively, in the S100/M2000 group (P &lt; 0.001 vs. S100 or M2000). For the open-label cohort (n = 117; baseline A1C 11.2%) treated with S100/M2000, the within-group mean A1C 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 that in the placebo group (0.6%). The incidence of gastrointestinal adverse experiences was similar for coadministration therapies compared with their respective metformin monotherapy. </p>
<p>The initial combination of sitagliptin and metformin provided substantial and additive glycemic improvement and was generally well tolerated in patients with type 2 diabetes.<br /><br /> Source : Diabetes Care August 2007</p>