Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Department of Endocrinology, Institute of Post Graduate Medical Education and Research, Kolkata, India.
Diabet Med. 2021 Mar;38(3):e14515. doi: 10.1111/dme.14515. Epub 2021 Jan 24.
To summarize all relevant randomized controlled trials (RCTs) and provide precise effect estimates of glycaemic efficacy/safety of faster-acting insulin aspart administered by injection as compared to insulin aspart in people with diabetes mellitus.
PubMed/Cochrane Library were systematically searched till October 10, 2020, to identify RCTs with duration ≥16 weeks, evaluating efficacy/safety of mealtime injections of faster aspart compared to insulin aspart in people with type 1 diabetes mellitus and type 2 diabetes mellitus. Studies using faster aspart as continuous subcutaneous insulin infusion were excluded. Continuous and dichotomous outcome variables (expressed as estimated treatment difference and rate ratio in RCTs, respectively) were pooled using generic inverse variance method with fixed/random-effects model. For each outcome variable, subgroup analysis between type 1 diabetes mellitus and type 2 diabetes mellitus was performed.
We included five RCTs; three of type 1 diabetes mellitus (n = 1963) and two of type 2 diabetes mellitus (n = 1780). All had low risk of bias. Faster aspart was associated with small but significant improvement in HbA than insulin aspart (MD: -0.06%, 95% CI: -0.10, -0.02, p = 0.005, I = 19%). HbA reduction was statistically significant only in type 1 diabetes mellitus on subgroup analysis (MD: -0.08%, 95% CI: -0.14, -0.02, p = 0.005, I = 47%). Besides, faster aspart was associated with reduced postprandial plasma glucose (PPG) increment at 1 h/2 h after meal test and increased 1,5-anhydroglucitol compared to insulin aspart. Early postprandial hypoglycaemic episodes were higher with faster aspart; however, overall and nocturnal hypoglycaemic episodes were not different from insulin aspart.
Faster aspart is associated with reduced HbA , PPG increment and comparable overall hypoglycaemic episodes with regard to insulin aspart.
总结所有相关的随机对照试验（RCT），并提供关于速效门冬胰岛素注射与门冬胰岛素相比在糖尿病患者中的血糖疗效/安全性的更精确的效应估计。
系统检索了 PubMed/Cochrane 图书馆，截至 2020 年 10 月 10 日，以确定持续时间≥16 周的 RCT，评估速效门冬与 1 型和 2 型糖尿病患者的餐时胰岛素相比的疗效/安全性。排除使用速效门冬作为连续皮下胰岛素输注的研究。使用固定/随机效应模型的通用逆方差法对连续和二项结局变量（在 RCT 中分别表示为估计治疗差异和率比）进行汇总。对于每个结局变量，在 1 型和 2 型糖尿病之间进行亚组分析。
我们纳入了 5 项 RCT，其中 3 项为 1 型糖尿病（n=1963），2 项为 2 型糖尿病（n=1780）。所有研究的偏倚风险均较低。与门冬胰岛素相比，速效门冬与 HbA 显著降低相关（MD：-0.06%，95%CI：-0.10，-0.02，p=0.005，I²=19%）。在亚组分析中，仅在 1 型糖尿病中 HbA 降低具有统计学意义（MD：-0.08%，95%CI：-0.14，-0.02，p=0.005，I²=47%）。此外，与门冬胰岛素相比，速效门冬可降低餐后 1 小时/2 小时血糖（PPG）增量，且 1,5-脱水葡萄糖醇升高。速效门冬引起的早期餐后低血糖发作较高，但与门冬胰岛素相比，总体和夜间低血糖发作无差异。
与门冬胰岛素相比，速效门冬与 HbA 降低、PPG 增量减少和总体低血糖发作相似。
