Horm Metab Res 2009; 41(12): 905-909
DOI: 10.1055/s-0029-1234042
Humans, Clinical

© Georg Thieme Verlag KG Stuttgart · New York

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

J. E. Foley1 , S. Sreenan2
  • 1Clinical Research & Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
  • 2Department of Endocrinology, Royal College of Surgeons in Ireland, Connolly Hospital, Dublin, Ireland
Further Information

Publication History

received 06.05.2009

accepted 30.06.2009

Publication Date:
24 August 2009 (online)

Abstract

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-naïve patients with type 2 diabetes are reported. A total of 546 patients were randomized and ∼74% of patients completed the study in each group. HbA1c values were slightly higher in the gliclazide group (HbA1c of 8.7±0.1% vs. 8.5±0.1% in the vildagliptin group). The mean reduction in HbA1c 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 on an 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-naïve patients with type 2 diabetes. Although the hypothesis of noninferiority to gliclazide was not borne out statistically, the reductions in HbA1c were similar over a two year period and vildagliptin had significant benefits in terms of less weight gain and less hypoglycemia.

References

1 * This trial (NCT00102388) is registered with ClinicalTrials. gov.

Correspondence

J. E. Foley

Clinical Research & Development

One Health Plaza

Novartis Pharmaceuticals

East Hanover

NJ

USA

Phone: +1/862/778 32 58

Fax: +1/973/781 84 96

Email: [email protected]