Robust improvements in fasting and prandial measures of β-cell function with vildagliptin in drug-naïve patients: analysis of pooled vildagliptin monotherapy database

  1. R. E. Pratley1,
  2. A. Schweizer2,
  3. J. Rosenstock3,
  4. J. E. Foley4,*,
  5. M. A. Banerji5,
  6. F. X. Pi-Sunyer6,
  7. D. Mills2,
  8. S. Dejager4

Article first published online: 17 DEC 2007

DOI: 10.1111/j.1463-1326.2007.00835.x

Issue

Diabetes, Obesity and Metabolism

Diabetes, Obesity and Metabolism

Volume 10, Issue 10, pages 931–938, October 2008

Additional Information

How to Cite

Pratley, R. E., Schweizer, A., Rosenstock, J., Foley, J. E., Banerji, M. A., Pi-Sunyer, F. X., Mills, D. and Dejager, S. (2008), Robust improvements in fasting and prandial measures of β-cell function with vildagliptin in drug-naïve patients: analysis of pooled vildagliptin monotherapy database. Diabetes, Obesity and Metabolism, 10: 931–938. doi: 10.1111/j.1463-1326.2007.00835.x

Author Information

  1. 1

    University of Vermont College of Medicine, Burlington, VT

  2. 2

    Novartis Pharma AG, Basel, Switzerland

  3. 3

    Dallas Diabetes and Endocrine Center, Dallas, TX

  4. 4

    Novartis Pharmaceuticals Corporation, East Hanover, NJ

  5. 5

    SUNY Downstate Medical Center, New York City, NY

  6. 6

    St Lukes-Roosevelt Hospital, New York City, NY

*James E. Foley, PhD, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. E-mail: james.foley@novartis.com

Publication History

  1. Issue published online: 15 SEP 2008
  2. Article first published online: 17 DEC 2007
  3. Received 5 July 2007; returned for revision 12 November 2007; revised version accepted 14 November 2007

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Keywords:

  • dipeptidyl peptidase-4;
  • GLP-1;
  • incretin hormones;
  • insulin secretion;
  • islet function

Aim:  To assess the effects of 24-week treatment with vildagliptin on measures of β-cell function in a broad spectrum of drug-naïve patients with type 2 diabetes (T2DM).

Methods:  Data from all double-blind, multicentre, randomized, placebo- or active-controlled trials conducted in drug-naïve patients with T2DM were pooled from all patients receiving monotherapy with vildagliptin (100 mg daily: 50 mg twice daily or 100 mg once daily, n = 1855) or placebo (n = 347). Fasting measures of β-cell function [homeostasis model assessment of β-cell function (HOMA-B) and proinsulin : insulin ratio] were assessed in the overall pooled monotherapy population. Standard meal tests were performed at baseline and week 24 in a subset of patients, and effects of vildagliptin (100 mg daily, n = 227) on dynamic (meal test–derived) measures of β-cell function [insulin secretion rate relative to glucose (ISR/G) and insulinogenic indices] were assessed relative to baseline and vs. placebo (n = 29).

Results:  In the overall population, vildagliptin significantly increased HOMA-B both relative to baseline [adjusted mean change (AMΔ) = 10.3 ± 1.5] and vs. placebo (between-treatment difference in AMΔ = 11.5 ± 4.5, p = 0.01) and significantly decreased the proinsulin : insulin ratio relative to baseline (AMΔ = −0.05 ± 0.01) and vs. placebo (between-treatment difference in AMΔ = −0.09 ± 0.02, p < 0.001). Relative to baseline, vildagliptin monotherapy significantly increased all meal test–derived parameters, and ISR/G (between-treatment difference in AMΔ = 9.8 ± 2.8 pmol/min/m2/mM, p < 0.001) and the insulinogenic index0–peak glucose (between-treatment difference in AMΔ = 0.24 ± 0.05 pmol/mmol, p = 0.045) were significantly increased vs. placebo.

Conclusions:  Vildagliptin monotherapy consistently produced robust improvements in both fasting and meal test–derived measures of β-cell function across a broad spectrum of drug-naïve patients with T2DM.

All Phase III trials described (NCT 00099905, NCT 00099866, NCT 00099918, NCT 00101673, NCT 00101803 and NCT 00120536) are registered with ClinicalTrials.gov.

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