Clinical efficacy and safety of insulin aspart compared with regular human insulin in patients with type 1 and type 2 diabetes: a systematic review and meta-analysis.

Abstract

Prandial insulin is a key component in insulin treatment of type 1 diabetes mellitus (T1DM) and in many patients with type 2 diabetes mellitus (T2DM). The evidence-based data supporting the choice of an insulin preparation are still limited. We performed a systematic review to summarize and update the evidence on relative efficacy and safety of insulin aspart (IAsp) and regular human insulin (RHI) in both types of diabetes. Randomized controlled trials comparing IAsp with RHI in patients with either T1DM or T2DM and conducted until May 2013 were retrieved from a systematic search of MEDLINE, EMBASE, and Cochrane Library. Of 16 relevant trials, 11 involved patients with T1DM and 5--with T2DM. In the T1DM population, IAsp, when compared with RHI, provided a greater reduction in hemoglobin A₁c (HbA₁c) levels (weighted mean difference [WMD], -0.11%; 95% confidence interval [CI], -0.16 to -0.05; WMD, -1.2 mmol/mol; 95% CI, -1.7 to -0.5), and improved postprandial glucose levels following breakfast (WMD, -1.40 mmol/l; 95% CI, -1.72 to -1.07), lunch (WMD, -1.01 mmol/l; 95% CI, -1.61 to -0.41), and dinner (WMD, -0.89 mmol/l; 95% CI, -1.19 to -0.59). The risk of nocturnal hypoglycemia was lower in T1DM patients receiving IAsp (relative risk, 0.76; 95% CI, 0.64-0.91), while no difference was observed for severe hypoglycemia. In T2DM patients, IAsp led to a greater reduction in HbA₁c levels (WMD, -0.22%; 95% CI, -0.39 to -0.05; -2.4 mmol/mol, -4.3 to -0.5) and postprandial blood glucose. The risk of overall hypoglycemia and severe adverse effects was comparable between the groups. IAsp provides better glycemic control when compared with RHI in patients with T1DM and T2DM. Fewer T1DM patients treated with IAsp experienced nocturnal hypoglycemia, while both interventions showed a comparable risk of severe hypoglycemic events in both types of diabetes.