Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION)
2015 (English)In: Diabetes, obesity and metabolism, ISSN 1462-8902, E-ISSN 1463-1326, Vol. 17, no 7, 630-638 p.Article in journal (Refereed) Published
Aims: To assess the efficacy and safety of adjunctive saxagliptin vs glimepiride in elderly patients with type 2 diabetes (T2D) and inadequate glycaemic control. Methods: In this multinational, randomized, double-blind, phase IIIb/IV study (GENERATION; NCT01006603), patients aged greater than= 65 years were randomized (1:1) to receive saxagliptin 5 mg/day or glimepiride less than= 6 mg/day, added to metformin, during a 52-week treatment period. The primary endpoint was achievement of glycated haemoglobin (HbA1c) less than7.0% at week 52 without confirmed/severe hypoglycaemia. The key secondary endpoint was incidence of confirmed/severe hypoglycaemia. Safety and tolerability were also assessed. Results: Of 720 patients randomized (360 in each treatment group; mean age 72.6 years; mean T2D duration 7.6 years), 574 (79.8%) completed the study (saxagliptin 80.3%; glimepiride 79.2%). Similar proportions of patients achieved the primary endpoint with saxagliptin and glimepiride (37.9 vs 38.2%; odds ratio 0.99, 95% confidence interval 0.73, 1.34; p=0.9415); however, a significant treatment-by-age interaction effect was detected (p=0.0389): saxagliptin was numerically (but not significantly) superior to glimepiride for patients aged less than75 years (39.2 vs 33.3%) and numerically inferior for patients aged greater than= 75 years (35.9 vs 45.5%). The incidence of confirmed/severe hypoglycaemia was lower with saxagliptin vs glimepiride (1.1 vs 15.3%; nominal pless than0.0001). Saxagliptin was generally well tolerated, with similar incidences of adverse events compared with glimepiride. Conclusion: As avoiding hypoglycaemia is a key clinical objective in elderly patients, saxagliptin is a suitable alternative to glimepiride in patients with T2D aged greater than= 65 years.
Place, publisher, year, edition, pages
Wiley , 2015. Vol. 17, no 7, 630-638 p.
dipeptidyl peptidase-4 inhibitor; randomized trial; sulphonylureas; type 2 diabetes
IdentifiersURN: urn:nbn:se:liu:diva-120138DOI: 10.1111/dom.12461ISI: 000356592200004PubMedID: 25761977OAI: oai:DiVA.org:liu-120138DiVA: diva2:841634
Funding Agencies|AstraZeneca; Bristol-Myers Squibb2015-07-142015-07-132015-07-14