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Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study†

  1. A. J. Garber1,*,
  2. A. Schweizer2,
  3. M. A. Baron3,
  4. E. Rochotte2,
  5. S. Dejager3

Article first published online: 14 DEC 2006

DOI: 10.1111/j.1463-1326.2006.00684.x

Issue

Diabetes, Obesity and Metabolism

Diabetes, Obesity and Metabolism

Volume 9, Issue 2, pages 166–174, March 2007

Additional Information

How to Cite

Garber, A. J., Schweizer, A., Baron, M. A., Rochotte, E. and Dejager, S. (2007), Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes, Obesity and Metabolism, 9: 166–174. doi: 10.1111/j.1463-1326.2006.00684.x

Author Information

  1. 1

    Division of Endocrinology, Baylor College of Medicine, Houston, TX, USA

  2. 2

    Novartis Pharma AG, Basel, Switzerland

  3. 3

    Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

*Alan J. Garber, Division of Endocrinology, Baylor College of Medicine, 6550 Fannin Street, Suite 1045, Houston, TX 77030, USA E-mail: agarber@bcm.tmc.edu

  • †

    This trial (NCT00099853) is registered with ClinicalTrials.gov.

Publication History

  1. Issue published online: 14 DEC 2006
  2. Article first published online: 14 DEC 2006
  3. Received 13 September 2006; returned for revision 6 October 2006; revised version accepted 10 October 2006

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Keywords:

  • dipeptidyl peptidase-4;
  • GLP-1;
  • HbA1c;
  • incretin hormones

Aim:  The purpose of this study was to assess the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor vildagliptin in combination with the thiazolidinedione (TZD) pioglitazone in patients with type 2 diabetes (T2DM).

Methods:  This was a 24-week, multicentre, double-blind, randomized, parallel-group study comparing the effects of vildagliptin (50 or 100 mg daily) with placebo as an add-on therapy to pioglitazone (45 mg daily) in 463 patients with T2DM inadequately controlled by prior TZD monotherapy. Between-treatment comparisons of efficacy parameters were made by analysis of covariance model.

Results:  The adjusted mean change (AMΔ) in haemoglobin A1c from baseline to endpoint was −0.8 ± 0.1% (p = 0.001 vs. placebo) and −1.0 ± 0.1% (p < 0.001 vs. placebo), respectively, in patients receiving vildagliptin 50 or 100 mg daily. Relative to baseline, vildagliptin added to pioglitazone also reduced fasting plasma glucose (FPG) (AMΔ FPG =−0.8 ± 0.2 mmol/l and −1.1 ± 0.2 mmol/l; not significant (NS) vs. placebo) and postprandial glucose (PPG) [AMΔ PPG =−1.9 ± 0.6 mmol/l and −2.6 ± 0.6 mmol/l (p = 0.008 vs. placebo)] for 50 and 100 mg daily respectively. Relative to placebo, both doses of vildagliptin significantly increased the insulin secretory rate/glucose by more than threefold. The overall incidence of adverse events (AEs) was 55.5, 50.0 and 48.7% in patients receiving vildagliptin 50 mg, 100 mg daily or placebo respectively. Serious AEs were experienced by 6.8, 1.3 and 5.7% of patients receiving vildagliptin 50 mg, 100 mg daily or placebo respectively. Mild hypoglycaemia was reported by 0, 0.6 and 1.9% of patients, respectively, receiving vildagliptin 50 mg, 100 mg daily or placebo.

Conclusion:  Vildagliptin is effective and well tolerated when added to a maximum dose of pioglitazone, without increasing the risk of hypoglycaemia.

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