Efficacy of vildagliptin in combination with insulin in patients with type 2 diabetes and severe renal impairment

acy of vildagliptin in combination with insulin in patients with type 2 diabetes and severe renal impairment Original Research (1726) Total Article Views Authors: Lukashevich V, Schweizer A, Foley JE, Dickinson S, Groop PH, Kothny W Published Date January 2013 Volume 2013:9 Pages 21 - 28 DOI: http://dx.doi.org/10.2147/VHRM.S39300 Received: 18 October 2012 Accepted: 26 November 2012 Published: 24 January 2013 Valentina Lukashevich,1 Anja Schweizer,2 James E Foley,1 Sheila Dickinson,2 Per-Henrik Groop,3 Wolfgang Kothny1 1Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 2Novartis Pharma AG, Basel, Switzerland; 3Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Folkh lsan Institute of Genetics, Folkh lsan Research Center, Biomedicum Helsinki, Finland, and Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia Background: The purpose of this study was to evaluate the efficacy of vildagliptin 50 mg once daily in patients with severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2) and longstanding type 2 diabetes not adequately controlled with insulin therapy, which is a difficult-to-treat population, with limited therapeutic options and a high susceptibility to hypoglycemia. Methods: This was a post hoc subanalysis of data obtained during a previously described randomized, double-blind, parallel-group, 24-week study comparing the efficacy and safety of vildagliptin 50 mg once daily versus placebo in patients with type 2 diabetes and moderate or severe renal impairment. The present data derive from 178 patients with severe renal impairment (baseline estimated glomerular filtration rate approximately 21 mL/min/1.73 m2, 100 randomized to vildagliptin, 78 randomized to placebo), all of whom were receiving insulin therapy (alone or in combination with an oral antidiabetic agent) for longstanding type 2 diabetes (mean approximately 19 years). Results: With vildagliptin in combination with insulin, the adjusted mean change (AMΔ) in HbA1c from baseline (7.7% ± 0.1%) was -0.9% ± 0.4% and the between-treatment difference (vildagliptin – placebo) was -0.6% ± 0.2% (P < 0.001). The percentage of patients achieving endpoint HbA1c < 7.0% was significantly higher with vildagliptin than placebo (45.2% versus 22.8%, P = 0.008). When added to insulin, vildagliptin and placebo had comparable hypoglycemic profiles and did not cause weight gain. Both treatments were similarly well tolerated, with comparable incidences of adverse events, serious adverse events, and deaths. Conclusion: When added to insulin therapy in patients with severe renal impairment and longstanding type 2 diabetes, vildagliptin 50 mg once daily was efficacious, eliciting HbA1c reductions consistent with those previously reported for a patient population with much more recent onset of type 2 diabetes and normal renal function, and had a hypoglycemic profile comparable with placebo. Accordingly, vildagliptin is a