Meta-analysis of insulin aspart versus regular human insulin used in a basal-bolus regimen for the treatment of diabetes mellitus - PubMed (original) (raw)

Meta-Analysis

Meta-analysis of insulin aspart versus regular human insulin used in a basal-bolus regimen for the treatment of diabetes mellitus

Simon Heller et al. J Diabetes. 2013 Dec.

Free PMC article

Abstract

Background: The objective of the current study was to compare the efficacy of two different insulin formulations, insulin aspart (IAsp) and regular human insulin (RHI), for prandial insulin coverage with neutral protamine Hagedorn (NPH) insulin as basal insulin using a meta-analysis approach. The primary endpoint was change in A1c 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 A1c was analyzed in extended simultaneous models.

Results: The mean difference in A1c was 0.1% (95% confidence interval [CI] [-0.15; -0.04], P < 0.001) in favor of IAsp. Higher accumulated dose of IAsp, higher age and increased rates of hypoglycemia were associated with improved A1c outcome. Fasting plasma glucose was not significantly different between regimens. Postprandial glucose was significantly lower after treatment with IAsp 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 IAsp.

Conclusions: A basal-bolus regimen with IAsp 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.

Keywords: human blood A1c protein; hypoglycemia; insulin aspart; meta-analysis.; regular human insulin; 人血A1c蛋白，低血糖，门冬胰岛素，常规人胰岛素，Meta分析.

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Figures

Figure 1

Change in A1c (%): per-trial and overall analysis of treatment difference at week 12.[Correction added on 7 June 2013, after first online publication: The last two _P_-values have been corrected from 0.01 to 0.005.]

Figure 2

Change in average blood glucose level (mmol/L) after breakfast, lunch and dinner: per-trial and overall analysis of treatment differences at week 16.

Figure 3

Per-trial and overall analysis of all hypoglycemic episodes (rate ratios with 95% confidence intervals).[Correction added on 7 June 2013, after first online publication: The _P_-value for ‘Type 1 and Type 2’ has been corrected from 0.01 to 0.005.]

Figure 4

Per-trial and overall analysis of nocturnal hypoglycemic episodes (rate ratios with 95% confidence intervals).

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Meta-analysis of insulin aspart versus regular human insulin used in a basal-bolus regimen for the treatment of diabetes mellitus - PubMed (original) (raw)