Authors' recommendations: One double-blind, 24-week, RCT demonstrated that the addition of saxagliptin to ongoing treatment with metformin and a sulfonylurea was statistically superior to placebo for reducing A1C in patients who were inadequately controlled on combination therapy with metformin and a sulfonylurea. The effect of saxagliptin on A1C (‒0.66%) was in the range considered clinically significant, and was aligned with effects of other DPP-4 inhibitors in the third-line setting. Saxagliptin was not associated with clinically important changes in body composition compared with placebo. AEs, SAEs, and WDAEs were more commonly reported with placebo than with saxagliptin. The proportion of patients with hypoglycemia was numerically greater in patients treated with saxagliptin compared with those treated with placebo (10% versus 6%), but most events were asymptomatic and there were no events of severe hypoglycemia. Hence, the likelihood of clinically significant hypoglycemia events with saxagliptin appears to be low. There was no evidence regarding the effects of saxagliptin added to metformin and sulfonylurea on the macrovascular and microvascular complications of diabetes, specifically in patients who were unable to use insulin.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.cadth.ca/media/cdr/clinical/SR0329_Onglyza_CL_Report_e.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Canadian Agency for Drugs and Technologies in Health

Contact Address: 600-865 Carling Avenue, Ottawa, ON K1S 5S8 Canada. Tel: +1 613 226 2553; Fax: +1 613 226 5392;

Contact Name: requests@cadth.ca

Contact Email: requests@cadth.ca

Copyright: Canadian Agency for Drugs and Technologies in Health (CADTH)