Horm Metab Res 2006; 38(6): 423-428
DOI: 10.1055/s-2006-944546
Original Clinical
© Georg Thieme Verlag KG Stuttgart · New York

Twelve-week Monotherapy with the DPP-4 Inhibitor Vildagliptin Improves Glycemic Control in Subjects with Type 2 Diabetes

R.  E.  Pratley1 , S.  Jauffret-Kamel2 , E.  Galbreath3 , D.  Holmes2
  • 1University of Vermont College of Medicine, Burlington, VT, USA
  • 2Novartis Pharma AG, Basel, Switzerland
  • 3Novartis Pharmaceuticals, East Hanover, NJ, USA
Further Information

Publication History

Received 11 August 2005

Accepted after revision 6 April 2006

Publication Date:
06 July 2006 (online)

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Abstract

Inhibition of dipeptidyl peptidase-4 enhances the activity of incretin hormones, improving glycemic control in subjects with type 2 diabetes. This twelve-week randomized, double-masked, placebo-controlled study assessed the efficacy and tolerability of the specific and potent oral dipeptidyl peptidase-4 inhibitor, vildagliptin (25 mg, bid, n = 70) vs. placebo (bid, n = 28) in previously diet-treated subjects with type 2 diabetes. Standardized meal tests were performed at baseline and endpoint. The between-group difference in adjusted mean change in HbA1c from baseline to endpoint was - 0.6 ± 0.2 % (p = 0.0012) for the whole cohort (baseline 8.0 %) and - 1.2 % for subjects with baseline HbA1c 8.0 - 9.5 %. Fasting glucose and mean prandial glucose were reduced by 1.1 ± 0.4 (p = 0.0043) and 1.9 ± 0.5 mmol/l (p < 0.0001), respectively. The between-group differences in corrected insulin response at peak glucose and mean prandial C-peptide were + 0.06 ± 0.02 (p = 0.0258) and + 0.10 ± 0.03 nmol/l (p = 0.0031), respectively. Vildagliptin had no effect on fasting lipid levels or body weight. The incidence of adverse events was similar in subjects receiving placebo (71.4 %) and vildagliptin (55.7 %). Conclusion: monotherapy with vildagliptin is well tolerated and improves glycemic control in diet-treated subjects with type 2 diabetes. Concomitant improvements in β-cell function were also observed. Subjects with higher baseline HbA1c levels showed greater response.

References

Richard E. Pratley, M. D.

Diabetes and Metabolism Translational Medicine Unit

University of Vermont College of Medicine · FAHC/Arnold 3412 · One South Prospect Street · Burlington · VT 05401 · USA ·

Phone: +1-(802) 847-8901

Fax: +1-(802) 847-3862

Email: richard.pratley@uvm.edu