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Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double‐blind, randomized, 1‐year study
Author(s) -
Rosenstock J.,
Wilson C.,
Fleck P.
Publication year - 2013
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12102
Subject(s) - alogliptin , glipizide , medicine , diabetes mellitus , type 2 diabetes , type 2 diabetes mellitus , pharmacology , gastroenterology , endocrinology , dipeptidyl peptidase 4
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.