You have free access to this content

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial

  1. M. A. Nauck1,
  2. G. Meininger2,
  3. D. Sheng2,
  4. L. Terranella2,
  5. P. P. Stein2,*,
  6. Sitagliptin Study 024 Group†

Article first published online: 26 JAN 2007

DOI: 10.1111/j.1463-1326.2006.00704.x

Issue

Diabetes, Obesity and Metabolism

Diabetes, Obesity and Metabolism

Volume 9, Issue 2, pages 194–205, March 2007

Additional Information

How to Cite

Nauck, M. A., Meininger, G., Sheng, D., Terranella, L., Stein, P. P. and Sitagliptin Study 024 Group (2007), Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes, Obesity and Metabolism, 9: 194–205. doi: 10.1111/j.1463-1326.2006.00704.x

Author Information

  1. 1

    Diabeteszentrum Bad Lauterberg im Harz, Bad Lauterberg, Germany

  2. 2

    Merck Research Laboratories, Rahway, NJ, USA

  1. †

    Study investigators are listed in ‡

*Peter P. Stein, MD, Merck Research Laboratories, 126 East Lincoln Avenue, Mail Code: RY34-A220, Rahway, NJ 07065-0900, USA. E-mail: peter_stein@merck.com

Publication History

  1. Issue published online: 26 JAN 2007
  2. Article first published online: 26 JAN 2007
  3. Received 24 October 2006; returned for revision 15 December 2006; revised version accepted 18 December 2006

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (191K)

Keywords:

  • dipeptidyl peptidase-IV;
  • DPP-IV;
  • incretins;
  • MK-0431;
  • sulfonylureas

Aim:  To compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [haemoglobin A1c (HbA1c) ≥ 6.5 and ≤10%] on metformin monotherapy.

Methods:  After a metformin dose titration/stabilization period (≥1500 mg/day), 1172 patients were randomized to the addition of sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (uptitrated to a potential maximum 20 mg/day) (N = 584) for 52 weeks. The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA1c changes from baseline at Week 52 using a per-protocol approach.

Results:  From a mean baseline of 7.5%, HbA1c changes from baseline were −0.67% at Week 52 in both groups, confirming non-inferiority. The proportions achieving an HbA1c < 7% were 63% (sitagliptin) and 59% (glipizide). Fasting plasma glucose changes from baseline were −0.56 mmol/l (−10.0 mg/dl) and −0.42 mmol/l (−7.5 mg/dl) for sitagliptin and glipizide, respectively. The proportion of patients experiencing hypoglycaemia episodes was significantly (p < 0.001) higher with glipizide (32%) than with sitagliptin (5%), with 657 events in glipizide-treated patients compared with 50 events in sitagliptin-treated patients. Sitagliptin led to weight loss (change from baseline =−1.5 kg) compared with weight gain (+1.1 kg) with glipizide [between-treatment difference (95% confidence interval) =−2.5 kg (−3.1, −2.0); p < 0.001].

Conclusions:  In this study, the addition of sitagliptin compared with glipizide provided similar HbA1c-lowering efficacy over 52 weeks in patients on ongoing metformin therapy. Sitagliptin was generally well tolerated, with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide.

View Full Article (HTML) Get PDF (191K)