Efficacy and safety of saxagliptin in older patients with type 2 diabetes mellitus

OBJECTIVE: To assess the safety and efficacy of saxagliptin (5 mg once-daily) in older patients (≥65 years of age) with inadequately controlled type 2 diabetes. RESEARCH DESIGN AND METHODS: In this retrospective subgroup analysis, data from five randomized, double-blind, placebo-controlled, multicenter, 24-week, phase 3 trials were included. The primary studies evaluated saxagliptin 5 mg once-daily (monotherapy or add-on) in patients aged 18-77 years with HbA(1c) ≥7.0% (four studies) or ≥7.5% (add-on to glyburide study) versus placebo. MAIN OUTCOME MEASURES: The primary efficacy endpoint of each study included in this pooled analysis was HbA(1c) change from baseline to week 24. RESULTS: In the five-study pooled population, 279 (16.6%) patients were at least 65 years old; 142 received saxagliptin 5 mg once-daily and 137 received placebo. Treatment groups were well-balanced for baseline characteristics within each study. In older patients, the HbA(1c) adjusted mean change from a baseline of 8.1% was -0.73 ± 0.16% (mean ± SEM) with saxagliptin compared with -0.17 ± 0.14% for placebo from a baseline of 8.0%. Adverse event rates were similar with saxagliptin 5 mg once-daily compared with placebo in older patients. CONCLUSION: The pooled subgroup analysis of saxagliptin 5 mg once-daily monotherapy and add-on therapy trials demonstrated clinically relevant and significant efficacy for reducing HbA(1c) in older (≥65 years) patients. Saxagliptin was well-tolerated in older patients with a low incidence of hypoglycemia and no weight gain.