Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN 37232-0475, USA.
Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.
We investigated the relationship between weight change and related factors in subjects with type 2 diabetes mellitus (T2DM) treated with liraglutide versus comparator diabetes therapies.
Twenty-six-week data from seven phase 3, randomized trials in the liraglutide T2DM development programme were analysed by trial and treatment group: liraglutide (1.2 and 1.8 mg), active comparator and placebo. Outcome measures included proportions of subjects in various weight change categories and their percentage weight change from baseline; impact of body mass index (BMI) and gastrointestinal (GI) adverse events (AEs) on weight change and correlation of weight change with change in glycosylated haemoglobin (HbA1c).
A number of subjects experienced >5% weight loss during the trials (24.4% liraglutide 1.8 mg and 17.7% liraglutide 1.2 mg; 17.7% exenatide, 10.0% sitagliptin, 3.6-7.0% sulphonylurea, 2.6% thiazolidinedione and 2.6% glargine; 9.9% placebo). More weight loss was seen with liraglutide 1.2 and 1.8 mg than with active comparators except exenatide. Across trials, higher initial BMI was associated with slightly greater weight loss with liraglutide. Mean weight loss increased slightly the longer GI AEs persisted. Although HbA1c reduction was slightly larger in higher weight loss categories across treatments (including placebo), sample sizes were small and no clear correlation could be determined. Liraglutide-treated subjects experienced additional HbA1c reduction beyond that which appeared weight induced; thus, not all HbA1c-lowering effect appears weight mediated.
The majority of liraglutide-treated T2DM subjects experienced weight loss in this analysis. Weight loss was greater and occurred more in glucagon-like peptide-1 receptor agonist-treated subjects than in active comparator-treated subjects.
我们研究了接受利拉鲁肽与对照糖尿病治疗的 2 型糖尿病（T2DM）患者体重变化与相关因素之间的关系。
对利拉鲁肽 T2DM 开发项目中 7 项 3 期随机试验的 26 周数据按试验和治疗组进行分析：利拉鲁肽（1.2mg 和 1.8mg）、活性对照和安慰剂。主要观察指标包括不同体重变化类别中患者的比例以及其与基线相比的体重变化百分比；体重指数（BMI）和胃肠道（GI）不良事件（AE）对体重变化的影响以及体重变化与糖化血红蛋白（HbA1c）变化的相关性。
在试验期间，一些患者经历了体重减轻>5%（利拉鲁肽 1.8mg 组为 24.4%，利拉鲁肽 1.2mg 组为 17.7%；艾塞那肽组为 17.7%，西格列汀组为 10.0%，磺酰脲类组为 3.6-7.0%，噻唑烷二酮类组为 2.6%，甘精胰岛素组为 2.6%；安慰剂组为 9.9%）。与活性对照相比，利拉鲁肽 1.2mg 和 1.8mg 组的体重减轻更多，除艾塞那肽外。在整个试验中，较高的初始 BMI 与利拉鲁肽的体重减轻略多相关。随着 GI AE 的持续时间延长，平均体重减轻略有增加。虽然在治疗中（包括安慰剂），体重减轻较多的患者的 HbA1c 降低幅度略大，但样本量较小，无法确定明确的相关性。利拉鲁肽治疗的患者在这种分析中除了体重诱导的 HbA1c 降低之外还经历了额外的 HbA1c 降低；因此，并非所有 HbA1c 降低的效果都与体重有关。
在这项分析中，大多数接受利拉鲁肽治疗的 T2DM 患者体重减轻。与活性对照治疗的患者相比，胰高血糖素样肽-1 受体激动剂治疗的患者体重减轻更多，且更常见。
