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Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus
University of Liege.
Corbeil Essonnes Hospital.
Linköping University, Department of Medicine and Health Sciences, General Practice. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Local Health Care Services in Finspång, Primary Health Care Centre.
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2010 (English)In: DIABETES-METABOLISM RESEARCH AND REVIEWS, ISSN 1520-7552, Vol. 26, no 7, 540-549 p.Article in journal (Refereed) Published
Abstract [en]

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 (HbA(1c)) 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 HbA(1c) at week 18 in per-protocol patients. Noninferiority was concluded if the upper limit of the two-sided 95% confidence interval of the HbA(1c) difference between treatments was andlt;0.3%. Results The adjusted mean changes in HbA(1c) 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.

Place, publisher, year, edition, pages
John Wiley and Sons, Ltd , 2010. Vol. 26, no 7, 540-549 p.
Keyword [en]
DPP-4 inhibitor, saxagliptin, sitagliptin, metformin, type 2 diabetes mellitus, combination therapy
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-61201DOI: 10.1002/dmrr.1114ISI: 000283399000005PubMedID: 20824678OAI: diva2:360877
Available from: 2010-11-05 Created: 2010-11-05 Last updated: 2010-12-07

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Östgren, Carl Johan
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