美国达拉斯糖尿病研究中心Julio Rosenstock团队研究了每周一次胰岛素治疗2型糖尿病的疗效。2020年9月22日，该研究发表在《新英格兰医学杂志》上。

人们认为减少基础胰岛素注射的频率可能会改善2型糖尿病患者的治疗依从性。正在研发中的icodec胰岛素是一种基础胰岛素类似物，每周一次给药，用于治疗糖尿病。

研究组进行了一项为期26周的随机、双盲、双模拟、2期临床试验，招募了247名未接受过长期胰岛素治疗、服用二甲双胍伴或不伴二肽基-肽酶4抑制剂后糖尿病控制不佳（糖化血红蛋白水平为7.0-9.5%）的患者，将其按1：1随机分组，分别接受每周一次icodec胰岛素和每日一次甘精U100胰岛素治疗。主要终点为治疗26周时糖化血红蛋白的变化。

两组患者的基线特征相似。icodec胰岛素组和甘精胰岛素组的平均基线糖化血红蛋白水平分别为8.09％和7.96％。治疗26周时，icodec胰岛素组的糖化血红蛋白水平与基线相比下降了1.33个百分点，甘精胰岛素组下降了1.15个百分点，两组的估计平均值分别为6.69％和6.87％，组间差异不显著。

icodec胰岛素组中2级或3级低血糖的发生率为每位患者每年0.53次，甘精胰岛素组为0.46次，差异不显著。两组间胰岛素相关的关键不良事件发生率无显著差异，超敏反应和注射部位反应的发生率较低。大多数不良事件为轻度，未发生与试验药物相关的严重不良事件。

研究结果表明，每周一次icodec胰岛素治疗2型糖尿病患者降糖效果显著，安全性好。

附：英文原文

Title: Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment | NEJM

Author: Julio Rosenstock, M.D.,, Harpreet S. Bajaj, M.D., M.P.H.,, Andrej Jane, M.D., Ph.D.,, Robert Silver, M.D.,, Kamilla Begtrup, M.Sc.,, Melissa V. Hansen, M.D., Ph.D.,, Ting Jia, M.D., Ph.D.,, and Ronald Goldenberg, M.D.

Issue&Volume: 2020-09-22

Abstract:

Background

It is thought that a reduction in the frequency of basal insulin injections might facilitate treatment acceptance and adherence among patients with type 2 diabetes. Insulin icodec is a basal insulin analogue designed for once-weekly administration that is in development for the treatment of diabetes.

Methods

We conducted a 26-week, randomized, double-blind, double-dummy, phase 2 trial to investigate the efficacy and safety of once-weekly insulin icodec as compared with once-daily insulin glargine U100 in patients who had not previously received long-term insulin treatment and whose type 2 diabetes was inadequately controlled (glycated hemoglobin level, 7.0 to 9.5%) while taking metformin with or without a dipeptidyl peptidase 4 inhibitor. The primary end point was the change in glycated hemoglobin level from baseline to week 26. Safety end points, including episodes of hypoglycemia and insulin-related adverse events, were also evaluated.

Results

A total of 247 participants were randomly assigned (1:1) to receive icodec or glargine. Baseline characteristics were similar in the two groups; the mean baseline glycated hemoglobin level was 8.09% in the icodec group and 7.96% in the glargine group. The estimated mean change from baseline in the glycated hemoglobin level was 1.33 percentage points in the icodec group and 1.15 percentage points in the glargine group, to estimated means of 6.69% and 6.87%, respectively, at week 26; the estimated between-group difference in the change from baseline was 0.18 percentage points (95% CI, –0.38 to 0.02, P=0.08). The observed rates of hypoglycemia with severity of level 2 (blood glucose level, <54 mg per deciliter) or level 3 (severe cognitive impairment) were low (icodec group, 0.53 events per patient-year; glargine group, 0.46 events per patient-year; estimated rate ratio, 1.09; 95% CI, 0.45 to 2.65). There was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low. Most adverse events were mild, and no serious events were deemed to be related to the trial medications.

Conclusions

Once-weekly treatment with insulin icodec had glucose-lowering efficacy and a safety profile similar to those of once-daily insulin glargine U100 in patients with type 2 diabetes.

DOI: 10.1056/NEJMoa2022474

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2022474