Original article 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 HbA1c � 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 HbA1c 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 HbA1c adjusted mean change from a