The online version of this article (doi:10.1007/s13300-014-0088-5) contains supplementary material, which is available to authorized users.
Trial registration: ClinicalTrials.gov #NCT00707993.
Adverse events and complications limit the long-term use of current antidiabetic treatment options for patients with type 2 diabetes mellitus (T2DM), particularly for older adults who are often receiving therapy for other comorbid conditions. The aim of this study was to evaluate the benefits of the dipeptidyl peptidase-4 inhibitor, alogliptin, versus glipizide, a sulfonylurea, in achieving glycemic control without the risk of hypoglycemia, weight gain, or both in older patients with T2DM.
This was an exploratory, post hoc analysis of a global, multicenter, randomized, double-blind, active-controlled study comparing alogliptin and glipizide. Patients (n = 441) aged 65–90 years with glycosylated hemoglobin (HbA1c) 6.5–9.0% who failed on diet and exercise alone or who had inadequately controlled T2DM despite oral antidiabetic monotherapy were recruited from 110 sites across 15 countries. Alogliptin 25 mg (n = 222) or glipizide 5 mg up-titrated to 10 mg (n = 219) was administered once daily for 52 weeks. Composite endpoints of HbA1c ≤7.0% coupled with the absence of hypoglycemia and weight gain, or an HbA1c reduction of ≥0.5% in the absence of hypoglycemia and weight gain, were then measured.
In the primary analysis, least squares mean HbA1c changes from baseline to Week 52 were similar in both the alogliptin and glipizide groups. The proportion of patients achieving HbA1c ≤7.0% without hypoglycemia or weight gain was significantly higher for alogliptin versus glipizide (24% vs 13%, p < 0.03). Patients with a baseline HbA1c of <8.0% receiving alogliptin were also more likely to achieve HbA1c ≤7.0% without hypoglycemia or weight gain than those receiving glipizide (29% vs 13%, p < 0.03).
Alogliptin demonstrated similar efficacy to glipizide in lowering HbA1c in older patients with T2DM, but with significantly more patients achieving an HbA1c ≤7.0% without hypoglycemia or an increase in body weight. These results particularly apply to patients with baseline HbA1c below 8.0%.
The study was sponsored by Takeda Global Research & Development Center, Inc., Deerfield, IL, and Takeda Global Research and Development Centre Ltd., London, United Kingdom.
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- A Post Hoc Analysis of HbA1c, Hypoglycemia, and Weight Change Outcomes with Alogliptin vs Glipizide in Older Patients with Type 2 Diabetes
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