Department of Endocrinology, Institute of Post Graduate Medical Education & Research, Kolkata, West Bengal, India.
Department of Endocrinology, Apollo Gleaneagles Hospital, Kolkata, West Bengal, India.
Endocr Pract. 2024 Feb;30(2):128-134. doi: 10.1016/j.eprac.2023.11.004. Epub 2023 Nov 19.
Once-weekly basal insulin icodec has been tested in clinical trials for efficacy and safety over currently available glargine-100 and degludec in different clinical settings for type 2 diabetes. We performed this meta-analysis to evaluate its overall safety and efficacy as compared to glargine-100 and degludec (nonicodec), from all available randomized controlled trials.
Seven trials comparing once-daily basal insulin analogs to once-weekly basal insulin icodec were included. Based on available information, outcomes in terms of HbA1c, fasting plasma glucose reduction, and increase in time in range (TIR) were compared. Side-effects were compared for overall hypoglycemia, severe hypoglycemia, and weight gain. The pooled effect size for continuously distributed data was measured as a reduction in "estimated differences in mean (with 95% CI)." For categorical data, the pooled effect size was measured as the Mantel-Haenszel risk ratio (with 95% CI).
Analyzing against the nonicodec comparators together, the "estimated mean changes" in HbA1c and fasting plasma glucose favoring icodec were -0.22% (-0.35, -0.10) and -1.59 mg% (-9.26, 6.08) respectively. The "estimated mean increment" in weight for icodec was 0.64 kg (0.61, 0.67). The "estimated mean percentage" increment in TIR for icodec was 4.24% (2.99, 5.49). The Mantel-Haenszel risk ratios for all hypoglycemic events and severe hypoglycemia for icodec were 1.24 (1.02, 1.50) (P = .03) and 0.81 (0.31, 2.08) (P is not significant), respectively, suggesting a 24% increased incidence of all hypoglycemia with icodec.
Once-weekly basal insulin icodec as compared to once-daily basal insulin analogs had a slight increase in the risk of overall hypoglycemia and weight gain, without any difference in severe hypoglycemia, with similar glycemic control (in terms of fasting plasma glucose, HbA1c, and TIR).
在不同的临床环境中,每周一次的基础胰岛素 Icodec 在疗效和安全性方面已经在临床试验中与目前可用的甘精胰岛素 100 和德谷胰岛素进行了测试,用于 2 型糖尿病。我们进行了这项荟萃分析,以评估与甘精胰岛素 100 和德谷胰岛素(非icodec)相比,其在所有可用的随机对照试验中的总体安全性和疗效。
纳入了 7 项比较每日一次基础胰岛素类似物与每周一次基础胰岛素 Icodec 的试验。根据现有信息,比较了 HbA1c、空腹血糖降低以及时间在范围内(TIR)增加的结果。比较了总体低血糖、严重低血糖和体重增加的副作用。对于连续分布数据,汇总效应大小以“估计均值差异(95%置信区间)”的减少量来衡量。对于分类数据,汇总效应大小以 Mantel-Haenszel 风险比(95%置信区间)来衡量。
与非icodec 对照物一起分析时,HbA1c 和空腹血糖倾向于 Icodec 的“估计平均变化”分别为-0.22%(-0.35,-0.10)和-1.59mg%(-9.26,6.08)。Icodec 的体重“估计平均增量”为 0.64kg(0.61,0.67)。Icodec 的 TIR“估计平均百分比增量”为 4.24%(2.99,5.49)。Icodec 的所有低血糖事件和严重低血糖的 Mantel-Haenszel 风险比分别为 1.24(1.02,1.50)(P=0.03)和 0.81(0.31,2.08)(P 无统计学意义),这表明 Icodec 的所有低血糖事件发生率增加了 24%。
与每日一次的基础胰岛素类似物相比,每周一次的基础胰岛素 Icodec 增加了总体低血糖和体重增加的风险,但严重低血糖没有差异,血糖控制相似(空腹血糖、HbA1c 和 TIR)。