Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Issue 7 (7th April 2015)

• Record Type: Journal Article
• Authors: Schernthaner, G.; Durán‐Garcia, S.; Hanefeld, M.; Langslet, G.; Niskanen, L.; Östgren, C. J.; Malvolti, E.; Hardy, E.
• Is Part Of: Diabetes, obesity & metabolism. Volume 17:Issue 7(2015:Jul.)
• Page Start: 630
• Page End: 638
• Publication Date: 2015-04-07
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12461
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12461-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12461-sec-0001" sec-type="section"> <title>Aims</title> <p id="dom12461-para-0001">To assess the efficacy and safety of adjunctive saxagliptin vs glimepiride in elderly patients with type 2 diabetes (T2D) and inadequate glycaemic control.</p> </sec> <sec id="dom12461-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12461-para-0002">In this multinational, randomized, double‐blind, phase IIIb/IV study (GENERATION; NCT01006603), patients aged ≥65 years were randomized (1 : 1) to receive saxagliptin 5 mg/day or glimepiride ≤6 mg/day, added to metformin, during a 52‐week treatment period. The primary endpoint was achievement of glycated haemoglobin (HbA1c) <7.0% at week 52 without confirmed/severe hypoglycaemia. The key secondary endpoint was incidence of confirmed/severe hypoglycaemia. Safety and tolerability were also assessed.</p> </sec> <sec id="dom12461-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12461-para-0003">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 <75 years (39.2 vs 33.3%) and numerically inferior for patients aged ≥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 p < 0.0001). Saxagliptin was generally well tolerated, with similar incidences of adverse events compared with glimepiride.</p> </sec> <sec id="dom12461-sec-0004" sec-type="section"> <title>Conclusion</title> <p id="dom12461-para-0004">As avoiding hypoglycaemia is a key clinical objective in elderly patients, saxagliptin is a suitable alternative to glimepiride in patients with T2D aged ≥65 years.</p> </sec> </abstract>