Kansai Electric Power Hospital, Osaka.
Global Development, Novo Nordisk A/S, Søborg, Denmark.
J Diabetes Investig. 2012 Aug 20;3(4):388-95. doi: 10.1111/j.2040-1124.2012.00193.x.
Aims/Introduction: β-cell function was evaluated by homeostasis model assessment of β-cell function (HOMA-B) index, proinsulin:insulin and proinsulin:C-peptide ratios in adult, Japanese type 2 diabetes patients receiving liraglutide.
Data from two randomized, controlled clinical trials (A and B) including 664 Japanese type 2 diabetes patients (mean values: glycated hemoglobin [HbA1c] 8.61-9.32%; body mass index [BMI] 24.4-25.3 kg/m(2)) were analyzed. In two 24-week trials, patients received liraglutide 0.9 mg (n = 268) or glibenclamide 2.5 mg (n = 132; trial A), or liraglutide 0.6, 0.9 mg (n = 176) or placebo (n = 88) added to previous sulfonylurea therapy (trial B).
Liraglutide was associated with improved glycemic control vs sulfonylurea monotherapy or placebo. In liraglutide-treated groups in trials A and B, area under the curve (AUC) insulin 0-3 h was improved (P < 0.001 for all) and the AUCinsulin 0-3 h:AUCglucose 0-3 h ratio was increased (estimated treatment difference [liraglutide-comparator] 0.058 [0.036, 0.079]). HOMA-B significantly increased with liraglutide relative to comparator in trial B (P < 0.05), but not in trial A. The reduction in fasting proinsulin:insulin ratio was 50% greater than in comparator groups.
In Japanese type 2 diabetes patients, liraglutide was associated with effective glycemic control, restoration of prandial insulin response and indications of improved β-cell function. This trial was registered with Clinicaltrials.gov (trial A: no. NCT00393718/JapicCTI-060328 and trial B: no. NCT00395746/JapicCTI-060324). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2012.00193.x, 2012).
目的/引言：在接受利拉鲁肽治疗的成年日本 2 型糖尿病患者中，通过稳态模型评估β细胞功能（HOMA-B）指数、胰岛素原与胰岛素比值以及胰岛素原与 C 肽比值评估β细胞功能。
分析了两项随机对照临床试验（A 和 B）中 664 例日本 2 型糖尿病患者的数据（平均值：糖化血红蛋白[HbA1c]8.61-9.32%；体重指数[BMI]24.4-25.3kg/m²）。在两项 24 周的试验中，患者接受利拉鲁肽 0.9mg（n=268）或格列本脲 2.5mg（n=132；试验 A），或利拉鲁肽 0.6、0.9mg（n=176）或安慰剂（n=88）联合之前的磺脲类药物治疗（试验 B）。
与磺脲类药物单药治疗或安慰剂相比，利拉鲁肽可改善血糖控制。在试验 A 和 B 的利拉鲁肽治疗组中，0-3 小时胰岛素 AUC 得到改善（所有组 P<0.001），0-3 小时胰岛素 AUC/葡萄糖 AUC 比值升高（估计治疗差异[利拉鲁肽-对照]0.058[0.036，0.079]）。与对照相比，试验 B 中利拉鲁肽治疗的 HOMA-B 显著增加（P<0.05），而试验 A 中则没有。空腹胰岛素原与胰岛素比值降低 50%，优于对照组。
在日本 2 型糖尿病患者中，利拉鲁肽可有效控制血糖，恢复餐后胰岛素反应，并提示β细胞功能改善。该试验在 Clinicaltrials.gov 上注册（试验 A：编号 NCT00393718/JapicCTI-060328；试验 B：编号 NCT00395746/JapicCTI-060324）。（《糖尿病研究与临床实践》，doi：10.1111/j.2040-1124.2012.00193.x，2012）。
