Horm Metab Res 2008; 40(12): 892-895
DOI: 10.1055/s-0028-1082334
Humans, Clinical

© Georg Thieme Verlag KG Stuttgart · New York

Efficacy and Safety of Vildagliptin Monotherapy during 2-Year Treatment of Drug-naïve Patients with Type 2 Diabetes: Comparison with Metformin

B. Göke 1 , K. Hershon 2 , D. Kerr 3 , A. Calle Pascual 4 , A. Schweizer 5 , J. Foley 6 , Q. Shao 6 , S. Dejager 7
  • 1Department of Internal Medicine II, University of Munich-Grosshadern, Munich, Germany
  • 2North Shore Diabetes and Endocrine Associates, New Hyde Park, New York, USA
  • 3Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, United Kingdom
  • 4Department of Endocrinology, Metabolism and Nutrition, Hospital Clinico San Carlos, Madrid, Spain
  • 5Novartis Pharma AG, Basel, Switzerland
  • 6Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA
  • 7Novartis Pharma SA, Development, Rueil-Malmaison, France
Further Information

Publication History

received 25.02.2008

accepted 27.05.2008

Publication Date:
22 August 2008 (online)

Abstract

The present study was a 52-week extension of a previously published, multi-center, randomized, parallel-group study. The aim of this extension study was to compare the efficacy and tolerability of vildagliptin and metformin in drug-naïve patients with type 2 diabetes over 104 weeks. The extension population comprised 305 patients randomized to vildagliptin (100 mg daily) and 158 patients randomized to metformin (2 000 mg daily). Pioglitazone was added as rescue medication if fasting glucose was >10 mmol/l; data from patients receiving rescue medication were excluded from the primary analysis. Baseline HbA1c averaged 8.4±0.1% in patients randomized to vildagliptin and 8.8±0.1% in those randomized to metformin. The adjusted mean change from baseline to study endpoint was −1.0±0.1% in vildagliptin-treated patients and −1.5±0.1% in those receiving metformin (p<0.001 vs. vildagliptin). These results were similar to those reported after the 1-year core phase of the study. The adjusted mean changes in body weight from baseline to endpoint were 0.5±0.4 kg and −2.5±0.5 kg in the vildagliptin and metformin groups, respectively. One or more adverse event (AE) was reported by 82.2% of patients receiving vildagliptin and by 87.3% of those receiving metformin (p<0.001). Gastrointestinal AEs were more common in patients receiving metformin (45.6%) than in those receiving vildagliptin (25.0%, p<0.001 vs. metformin). One hypoglycemic event occurred after strenuous exercise in a single patient receiving vildagliptin (0.3%). In conclusion, both vildagliptin and metformin monotherapy provided clinically meaningful decreases in HbA1c over 2 years in drug-naïve patients with type 2 diabetes. Vildagliptin was weight neutral, while weight loss was observed with metformin; however, metformin was associated with significantly worse gastrointestinal tolerability.

References

  • 1 Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Dunning BE, Deacon CF, Holst JJ, Foley JE. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed β-cell function in patients with type 2 diabetes.  J Clin Endocrinol Metab. 2005;  90 4888-4894
  • 2 Dejager S, Razac S, Foley JE, Schweizer A. Vildagliptin in drug-naïve patients with type 2 diabetes: a 24-week, double-blind, randomized, placebo-controlled, multiple-dose study.  Horm Metab Res. 2007;  39 218-223
  • 3 Rosenstock J, Baron MA, Dejager S, Mills D, Schweizer A. Comparison of vildagliptin and rosiglitazone monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trial.  Diabetes Care. 2007;  30 217-223
  • 4 Pi-Sunyer FX, Schweizer A, Mills D, Dejager S. Efficacy and tolerability of vildagliptin monotherapy in drug-naïve patients with type 2 diabetes.  Diabetes Res Clin Pract. 2007;  76 132-138
  • 5 Schweizer A, Couturier A, Foley JE, Dejager S. Comparison between vildagliptin and metformin to sustain reductions in HbA1c over 1 year in drug-naïve patients with type 2 diabetes.  Diabet Med. 2007;  24 955-961
  • 6 Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Wang Y, Dunning BE, Foley JE. Evidence that vildagliptin attenuates deterioration of glycaemic control during 2-year treatment of patients with type 2 diabetes and mild hyperglycaemia.  Diabetes Obes Metab. 2008;  , Published article online: 18 Mar 2008. doi: 10.1111/j.1463-1326.2008.00875.x
  • 7 Bailey CJ, Turner RC. Metformin.  N Engl J Med. 1996;  334 574-579
  • 8 Nauck MA, Heimesaat MM, Behle K, Holst JJ, Nauck MS, Ritzel R, Hüfner M, Schmiegel WH. Effects of glucagon-like peptide 1 on counterregulatory hormone responses, cognitive functions, and insulin secretion during hyperinsulinemic, stepped hypoglycemic clamp experiments in healthy volunteers.  J Clin Endocrinol Metab. 2002;  87 1239-1246
  • 9 Ahren B, Foley JE, Dunning BE. Alpha cell function in health and disease: influence of glucagon-like peptide-1.  Diabetologia. 2005;  48 1700-1713
  • 10 Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes.  Diabetologia. 2007;  50 1148-1155
  • 11 Talley NJ, Young L, Bytzer P, Hammer J, Leemon M, Jones M, Horowitz M. Impact of chronic gastrointestinal symptoms in diabetes mellitus on health-related quality of life.  Am J Gastroenterol. 2001;  96 71-76

The trial (NCT00138567) described here is registered with ClinicalTrials.gov.

Correspondence

J. Foley

Novartis Pharmaceuticals Corporation

One Health Plaza

East Hanover

07936-1080 New Jersey

USA

Phone: +1/862/778 32 58

Fax: +1/973/781 66 19

Email: james.foley@novartis.com

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