1520-7560/asset/bannerforeground.jpg?v=1&s=97ddd213ca98f827538987e02b801875335d1a52)
Research Article
Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus
Article first published online: 7 SEP 2010
DOI: 10.1002/dmrr.1114
Copyright © 2010 John Wiley & Sons, Ltd.
Additional Information
How to Cite
Scheen, A. J., Charpentier, G., Östgren, C. J., Hellqvist, Å. and Gause-Nilsson, I. (2010), Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus. Diabetes Metab. Res. Rev., 26: 540–549. doi: 10.1002/dmrr.1114
Publication History
- Issue published online: 29 SEP 2010
- Article first published online: 7 SEP 2010
- Manuscript Revised: 6 AUG 2010
- Manuscript Accepted: 6 AUG 2010
- Manuscript Received: 9 MAR 2010
- Abstract
- Article
- References
- Cited By
Keywords:
- DPP-4 inhibitor;
- saxagliptin;
- sitagliptin;
- metformin;
- type 2 diabetes mellitus;
- combination therapy
Abstract
Background
Dipeptidyl peptidase-4 inhibitors improve glycaemic control in patients with type 2 diabetes mellitus when used as monotherapy or in combination with other anti-diabetic drugs (metformin, sulphonylurea, or thiazolidinedione). This 18-week, phase 3b, multicentre, double-blind, noninferiority trial compared the efficacy and safety of two dipeptidyl peptidase-4 inhibitors, saxagliptin and sitagliptin, in patients whose glycaemia was inadequately controlled with metformin.
Methods
Adult type 2 diabetes mellitus patients (N = 801) with glycated haemoglobin (HbA1c) 6.5–10% on stable metformin doses (1500–3000 mg/day) were randomized 1 : 1 to add-on 5 mg saxagliptin or 100 mg sitagliptin once daily for 18 weeks. The primary efficacy analysis was a comparison of the change from baseline HbA1c at week 18 in per-protocol patients. Noninferiority was concluded if the upper limit of the two-sided 95% confidence interval of the HbA1c difference between treatments was < 0.3%.
Results
The adjusted mean changes in HbA1c following the addition of saxagliptin or sitagliptin to stable metformin therapy were − 0.52 and − 0.62%, respectively. The between-group difference was 0.09% (95% confidence interval, − 0.01 to 0.20%), demonstrating noninferiority. Both treatments were generally well tolerated; incidence and types of adverse events were comparable between groups. Hypoglycaemic events, mostly mild, were reported in approximately 3% of patients in each treatment group. Body weight declined by a mean of 0.4 kg in both groups.
Conclusions
Saxagliptin added to metformin therapy was effective in improving glycaemic control in patients with type 2 diabetes mellitus inadequately controlled by metformin alone; saxagliptin plus metformin was noninferior to sitagliptin plus metformin, and was generally well tolerated. Copyright © 2010 John Wiley & Sons, Ltd.