Meta‐analysis of insulin aspart versus regular human insulin used in a basal–bolus regimen for the treatment of diabetes mellitus (在基础—餐时糖尿病治疗方案中使用门冬胰岛素与使用常规人胰岛素对照研究的Meta分析)

Abstract

Background: The objective of the current study was to compare the efficacy of two different insulin formulations, insulin aspart (IA sp) and regular human insulin (RHI), for prandial insulin coverage with neutral protamine H agedorn (NPH) insulin as basal insulin using a meta‐analysis approach. The primary endpoint was change in A 1c over time. Secondary endpoints included incidence of hypoglycemia and postprandial glycemic control. Methods: Clinical trials (Type 1 and Type 2 diabetes) complying with Good Clinical Practice, and with individual patient data, were included in the meta‐analysis. Trials were randomized, consisting of (at least) two treatment arms and had a minimum duration of 12 weeks. Estimates were calculated using fixed‐effects and random‐effects models. Heterogeneity was assessed for each analysis. The effect of baseline parameters on A 1c was analyzed in extended simultaneous models. Results: The mean difference in A 1c was 0.1% (95% confidence interval [CI] [−0.15; −0.04], P < 0.001) in favor of IA sp. Higher accumulated dose of IA sp, higher age and increased rates of hypoglycemia were associated with improved A 1c outcome. Fasting plasma glucose was not significantly different between regimens. Postprandial glucose was significantly lower after treatment with IA sp compared with RHI, but the analysis did present a significant level of heterogeneity (P < 0.001). The overall rate of hypoglycemia was the same with both regimens, but nocturnal hypoglycemia was significantly lower with IA sp. Conclusions: A basal–bolus regimen with IA sp as bolus insulin provided minimal, but statistically significant, improvement in overall glycemic control with a lower rate of nocturnal hypoglycemic episodes, compared with a corresponding regimen with bolus RHI.