Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double‐blind, randomized, 1‐year study1. Issue 10 (18th April 2013) - Rosenstock, J.
Abstract : Aim: To prospectively evaluate the efficacy and safety of alogliptin versus glipizide in elderly patients with type 2 diabetes mellitus (T2DM) over 1 year of treatment. Methods: This was a randomized, double‐blind, active‐controlled study of elderly T2DM patients (aged 65–90 years) with mild hyperglycaemia on diet/exercise therapy alone [glycosylated haemoglobin (HbA1c) 6.5–9.0%] or plus oral antidiabetic monotherapy (HbA1c 6.5–8.0%). Patients were randomized to once‐daily alogliptin 25 mg or glipizide 5 mg titrated to 10 mg, if needed. Hypoglycaemic episodes were systematically captured under predefined criteria. Results: In the primary analysis, HbA1c mean changes from a baseline of 7.5% were −0.14% with alogliptin (n = 222) and −0.09% with glipizide (n = 219) at the end of the study, demonstrating non‐inferiority of alogliptin to glipizide [least squares (LS) mean difference = −0.05%; one‐sided 97.5% confidence interval (CI): −∞, 0.13%]. More clinically relevant HbA1c reductions occurred among patients who completed the study: −0.42 and −0.33% with alogliptin and glipizide, with non‐inferiority again confirmed (LS mean difference = −0.09%; one‐sided 97.5% CI: −∞, 0.07%). Overall, alogliptin was safe and well tolerated, with notably fewer hypoglycaemic episodes than glipizide [5.4% (31 episodes) vs. 26.0% (232 episodes), respectively]; three patients experienced severe hypoglycaemia, all with glipizide. Alogliptin also resulted in favourable weight changes versus glipizide (−0.62 vs. 0.60 kg at week 52; p < 0.001). Conclusions: Alogliptin monotherapy maintained glycaemic control comparable to that of glipizide in elderly patients with T2DM over 1 year of treatment, with substantially lower risk of hypoglycaemia and without weight gain.