Durability of the efficacy and safety of alogliptin compared with glipizide in type 2 diabetes mellitus: a 2‐year study1. Issue 12 (25th September 2014)

• Record Type: Journal Article
• Authors: Del Prato, S.; Camisasca, R.; Wilson, C.; Fleck, P.
• Is Part Of: Diabetes, obesity & metabolism. Volume 16:Issue 12(2014:Dec.)
• Page Start: 1239
• Page End: 1246
• Publication Date: 2014-09-25
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12377
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12377-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12377-sec-0001" sec-type="section"> <title>Aims</title> <p id="dom12377-para-0001">To evaluate the long‐term durability of the efficacy of alogliptin compared with glipizide in combination with metformin in people with type 2 diabetes inadequately controlled on stable‐dose metformin.</p> </sec> <sec id="dom12377-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12377-para-0002">This multicentre, double‐blind, active‐controlled study randomized 2639 patients aged 18–80 years to 104 weeks of treatment with metformin in addition to alogliptin 12.5 mg once daily (n = 880), alogliptin 25 mg once daily (n = 885) or glipizide 5 mg once daily, titrated to a maximum of 20 mg (n = 874). The primary endpoint was least square mean change from baseline in HbA1c level at 104 weeks.</p> </sec> <sec id="dom12377-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12377-para-0003">The mean patient age was 55.4 years, the mean diabetes duration was 5.5 years and the mean baseline HbA1c was 7.6%. HbA1c reductions at week 104 were −0.68%, −0.72% and −0.59% for alogliptin 12.5 and 25 mg and glipizide, respectively [both doses met the criteria for non‐inferiority to glipizide (p<0.001); alogliptin 25 mg met superiority criteria (p=0.010)]. Fasting plasma glucose concentration decreased by 0.05 and 0.18 mmol/l for alogliptin 12.5 and 25 mg, respectively, and increased by 0.30 mmol/l for glipizide (p < 0.001 for both comparisons with glipizide). Mean weight changes were −0.68, −0.89 and 0.95 kg for alogliptin 12.5 and 25 mg and glipizide, respectively (p < 0.001 for both comparisons with glipizide). Hypoglycaemia occurred in 23.2% of patients in the glipizide group vs. 2.5 and 1.4% of patients in the alogliptin 12.5 and 25 mg groups, respectively. Pancreatitis occurred in one patient in the alogliptin 25 mg group and three in the glipizide group.</p> </sec> <sec id="dom12377-sec-0004" sec-type="section"> <title>Conclusions</title> <p id="dom12377-para-0004">Alogliptin efficacy was sustained over 2 years in patients with inadequate glycaemic control on metformin alone.</p> </sec> </abstract>