Efficacy and safety of insulin lispro in obese patients with type 2 diabetes: a retrospective metaanalysis of 7 randomized controlled trials.

Objective: To evaluate the efficacy and safety of insulin lispro in the treatment of patients with type 2 diabetes (T2DM) who had a body mass index (BMI) >= 30 kg/m(2) (obese) compared with patients with BMIs <30 kg/m(2) (nonobese). Methods: A retrospective analysis of predefined end-points from 7 randomized clinical trials of T2DM patients treated with insulin lispro was performed. The primary efficacy measure was to assess the noninferiority of insulin lispro in obese patients versus nonobese patients as measured by the change in hemoglobin A1C (HbA(1c)) from baseline to Month 3 (n = 1,518), using a noninferiority margin of 0.4%. The secondary measures included overall hypoglycemia incidence and event rates and relative change in body weight. Results: Mean changes in HbA(1c) from baseline (9.06% for obese and 8.92% for nonobese) to Month 3 were similar for obese patients (-1.03%) and nonobese (-1.02%), with a least squares (LS) mean difference (95% confidence interval [CI]) of -0.05% (-0.17%, 0.07%; P = .384). The overall incidence of hypoglycemia (53% vs. 63%; P < .001) and rate of hypoglycemia (0.93 vs. 1.76 events per 30 days; P < .001) was significantly lower in obese patients compared with nonobese patients. The 2 BMI cohorts did not demonstrate a significant difference in mean percent changes in body weights (LS mean difference = 0.4% [-0.2%, 0.9%]; P = .202). Conclusion: Obese patients with T2DM treated with insulin lispro were able to achieve the same level of glycemic control as their nonobese counterparts, with some evidence supporting a reduced risk of hypoglycemia.