Effects of Vildagliptin on Glucose Control Over 24 Weeks in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

  1. Emanuele Bosi, MD1,
  2. Riccardo Paolo Camisasca, MD2,
  3. Carole Collober, MSC2,
  4. Erika Rochotte, MSC2 and
  5. Alan J. Garber, MD, PHD3
  1. 1Diabetes and Endocrinology Unit, Department of General Medicine, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy
  2. 2Novartis Pharma, Basel, Switzerland
  3. 3Baylor College of Medicine, Houston, Texas
  1. Address correspondence and reprint requests to Alan J. Garber, MD, PhD, Baylor College of Medicine, 6550 Fannin St., Suite 1045, Houston, TX 77030. E-mail: agarber{at}bcm.tmc.edu

Abstract

OBJECTIVE—We sought to evaluate the efficacy and safety of vildagliptin, a new dipeptidyl peptidase-4 inhibitor, added to metformin during 24 weeks of treatment in patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS—This was a double-blind, randomized, multicenter, parallel group study of a 24-week treatment with 50 mg vildagliptin daily (n = 177), 100 mg vildagliptin daily (n = 185), or placebo (n = 182) in patients continuing a stable metformin dose regimen (≥1,500 mg/day) but achieving inadequate glycemic control (A1C 7.5–11%).

RESULTS—The between-treatment difference (vildagliptin − placebo) in adjusted mean change (AMΔ) ± SE in A1C from baseline to end point was −0.7 ± 0.1% (P < 0.001) and −1.1 ± 0.1% (P < 0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. The between-treatment difference in the AMΔ fasting plasma glucose (FPG) was −0.8 ± 0.3 mmol/l (P = 0.003) and −1.7 ± 0.3 mmol/l (P < 0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. Adverse events (AEs) were reported by 63.3, 65.0, and 63.5% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. Gastrointestinal AEs were reported by 9.6 (P = 0.022 vs. placebo), 14.8, and 18.2% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. One patient in each treatment group experienced one mild hypoglycemic event.

CONCLUSIONS—Vildagliptin is well tolerated and produces clinically meaningful, dose-related decreases in A1C and FPG as add-on therapy in patients with type 2 diabetes inadequately controlled by metformin.

Footnotes

  • Published ahead of print at http://care.diabetesjournals.org on 2 February 2007. DOI: 10.2337/dc06-1732. Clinical trial reg. no. NCT00099892, clinicaltrials.gov.

    E.B. has received a research grant and honoraria from Novartis. R.P.C., C.C., and E.R. are employees and stockholders of Novartis. A.J.G. has received grants and research support from Novartis and is a member of the advisory board for Novartis.

    Additional information for this article can be found in an online appendix at http://dx.doi.org/10.2337/dc06-1732.

    A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.

    • Accepted December 19, 2006.
    • Received August 15, 2006.
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  1. Diabetes Care vol. 30 no. 4 890-895
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