一项为期 52 周、随机、多中心的试验，旨在比较新型胰高血糖素样肽-1 类似物利拉鲁肽与格列本脲在 2 型糖尿病患者中的安全性和疗效。
Fifty-two-week, randomized, multicenter trial to compare the safety and efficacy of the novel glucagon-like peptide-1 analog liraglutide vs glibenclamide in patients with type 2 diabetes.
机构信息
Division of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Okayama.
Medical and Science, GLP-1, Novo Nordisk A/S, Bagsvaerd, Denmark.
出版信息
J Diabetes Investig. 2011 Nov 30;2(6):441-7. doi: 10.1111/j.2040-1124.2011.00128.x.
UNLABELLED
Aims/Introduction: We compared the safety and efficacy of liraglutide vs glibenclamide in patients with poorly controlled (HbA1c, 7.4-10.4%) type 2 diabetes.
MATERIALS AND METHODS
Subjects were randomly assigned at a 1:2 ratio to receive 1-year treatment with glibenclamide 1.25-2.5 mg/day or liraglutide 0.9 mg/day. Other oral anti-diabetic drugs (OAD) were prohibited during the trial. Adverse events (AE) were monitored.
RESULTS
A total of 400 patients (liraglutide group, n = 268; glibenclamide group, n = 132) were randomized and exposed to trial products. At week 52 vs baseline, HbA1c in the liraglutide and glibenclamide groups was reduced from 9.3 to 7.8% and from 9.2 to 8.2%, respectively. Treatment difference (liraglutide - glibenclamide) at the end of the study was -0.49 (95% CI, -0.71 to -0.27). In the liraglutide and glibenclamide groups, Japan Diabetes Society target HbA1c < 6.9% was achieved by 22.1 and 8.5% of patients, respectively. Fasting plasma glucose fell from 202.8 and 202.1 mg/dL, respectively, to 145.3 and 156.7 mg/dL, respectively. Mean plasma glucose and mean postprandial plasma glucose increment were lower in the liraglutide group. Mean bodyweight was reduced by -0.8 kg in the liraglutide group and increased by 1.0 kg in the glibenclamide group. The proportion of patients reporting at least one treatment-emergent AE (TEAE) in the liraglutide and glibenclamide groups was 91.4 and 91.7%, respectively. Most TEAE were mild in severity. No major hypoglycemic episode was observed.
CONCLUSIONS
Once-daily administration of liraglutide 0.9 mg for 52 weeks provides more favorable metabolic control and safety profile compared with glibenclamide. Patients on liraglutide lost bodyweight, whereas those on glibenclamide gained weight. This trial was registered with ClinicalTrial.gov (no. NCT00393718). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00128.x, 2011).
目的/引言：我们比较了利拉鲁肽和格列本脲在血糖控制不佳（HbA1c，7.4-10.4%）的 2 型糖尿病患者中的安全性和疗效。
材料和方法
患者按 1:2 的比例随机分配，接受为期 1 年的格列本脲 1.25-2.5mg/天或利拉鲁肽 0.9mg/天治疗。试验期间禁止使用其他口服降糖药（OAD）。监测不良事件（AE）。
结果
共有 400 名患者（利拉鲁肽组，n=268；格列本脲组，n=132）被随机分配并接受试验药物。与基线相比，利拉鲁肽组和格列本脲组在第 52 周时的 HbA1c 分别从 9.3%降至 7.8%和从 9.2%降至 8.2%。研究结束时的治疗差异（利拉鲁肽-格列本脲）为-0.49（95%CI，-0.71 至-0.27）。在利拉鲁肽组和格列本脲组中，分别有 22.1%和 8.5%的患者达到了日本糖尿病学会（JDS）目标 HbA1c<6.9%。空腹血糖分别从 202.8 和 202.1mg/dL 降至 145.3 和 156.7mg/dL。利拉鲁肽组的平均血浆血糖和平均餐后血浆血糖升高幅度较低。利拉鲁肽组的平均体重减轻了 0.8kg，而格列本脲组的体重增加了 1.0kg。利拉鲁肽组和格列本脲组分别有 91.4%和 91.7%的患者报告至少发生了 1 次治疗相关不良事件（TEAE）。大多数 TEAE 为轻度。未观察到严重的低血糖事件。
结论
利拉鲁肽 0.9mg 每日 1 次治疗 52 周可提供更有利的代谢控制和安全性，优于格列本脲。利拉鲁肽组患者体重减轻，而格列本脲组患者体重增加。该试验已在 ClinicalTrials.gov 注册（编号：NCT00393718）。（《糖尿病研究与临床实践》，doi:10.1111/j.2040-1124.2011.00128.x，2011）。
Zotero 插件