Efficacy and Safety Comparison Between the DPP-4 Inhibitor Vildagliptin and the Sulfonylurea Gliclazide After Two Years of Monotherapy in Drug-naive Patients with Type 2 Diabetes

This report is part of the overall evaluation of using vildagliptin in the treatment of type 2 diabetes. Here the results of a multi-center, double-blind, randomized, active-controlled Study designed to compare the efficacy and safety of two years of monotherapy with vildagliptin 50 mg bid and gliclazide up to 320 mg/day in drug-naive patients with type 2 diabetes are reported. A total of 546 patients were randomized and similar to 74% of patients completed the Study in each group. HbA(1c) values were slightly higher in the gliclazide group (HbA(1c) of 8.7 +/- 0.1 % vs. 8.5 +/- 0.1 % in the vildagliptin group). The mean reduction in HbA(1)c, from baseline to Week 104 was -0.5% in the vildagliptin group and -0.6% in the gliclazide group. The associated 95 % confidence interval (CI) for the between-group difference (0.13%) in mean change was (-0.06%, 0.33%). Thus, noninferiority based oil all upper limit of the CI of 0.3% was not met. In the vildagliptin group, weight increased by 0.8 +/- 0.2 kg compared to 1.6 +/- 0.2 kg in the gliclazide group (p<0.01). Mild hypoglycemia was recorded in 0.7% of patients in the vildagliptin group and in 1.7% in the gliclazide group. Both drugs were well tolerated. In Summary, vildagliptin monotherapy resulted in improved glycemic control in drug-naive patients with type 2 diabetes. Although the hypothesis of noninferiority to gliclazide was not borne Out statistically, the reductions in HbA(1c), were similar over a two year period and vildagliptin had significant benefits in terms of less weight gain and less hypoglycemia.