Nauck M A, Hompesch M, Filipczak R, Le T D T, Zdravkovic M, Gumprecht J
Diabeteszentrum, Bad Lauterberg im Harz, Germany.
Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23. doi: 10.1055/s-2006-924230.
Effects of the long acting GLP-1 analogue--liraglutide in subjects with type 2 diabetes.
144 type 2 diabetic subjects on metformin treatment (1000 mg BID) were randomised to 5 weeks of treatment (double-blind) with metformin plus liraglutide, liraglutide or metformin, or metformin plus glimepiride (open label). The dose of liraglutide was increased weekly from 0.5 to 2 mg OD.
Liraglutide added to metformin monotherapy was associated with a significant reduction in fasting serum glucose (FSG) (-3.9 mM -4.9; -2.9) (primary objective), and HbA1c levels (-0.8% -1.2; -0.4). Furthermore, liraglutide in combination with metformin vs. metformin plus glimepiride significantly reduced FSG (-1.2 mM -2.2; -0.2). In addition, body weight was significantly lower in the metformin plus liraglutide vs. the metformin plus glimepiride group (-2.9 kg -3.6; -2.1). There were no biochemically confirmed episodes of hypoglycaemia with liraglutide treatment. Nausea was the most frequently reported adverse event following liraglutide therapy, it was transient in nature, and led to withdrawal of only 4% of the subjects.
Using a weekly dose-titration liraglutide is well tolerated up to 2 mg daily. While liraglutide caused transient gastrointestinal side effects, this rarely interfered with continuing treatment. An improvement in FSG over that in control groups was seen for liraglutide as an add-on to metformin. In the latter case, body weight was reduced in comparison to metformin plus glimepiride. Liraglutide is a promising drug for the treatment of type 2 diabetes.
长效胰高血糖素样肽-1类似物利拉鲁肽对2型糖尿病患者的影响。
144名接受二甲双胍治疗（每日两次，每次1000毫克）的2型糖尿病患者被随机分为四组，分别接受为期5周的治疗（双盲）：二甲双胍加用利拉鲁肽、利拉鲁肽、二甲双胍或二甲双胍加用格列美脲（开放标签）。利拉鲁肽的剂量每周从0.5毫克增加至每日2毫克。
二甲双胍单药治疗加用利拉鲁肽可使空腹血糖（FSG）显著降低（-3.9毫摩尔 -4.9；-2.9）（主要目标），糖化血红蛋白（HbA1c）水平降低（-0.8%-1.2；-0.4）。此外，与二甲双胍加用格列美脲相比，利拉鲁肽联合二甲双胍可显著降低空腹血糖（-1.2毫摩尔 -2.2；-0.2）。此外，二甲双胍加用利拉鲁肽组的体重显著低于二甲双胍加用格列美脲组（-2.9千克 -3.6；-2.1）。利拉鲁肽治疗未出现经生化证实的低血糖发作。恶心是利拉鲁肽治疗后最常报告的不良事件，呈一过性，仅导致4%的受试者停药。
使用每周剂量滴定法，利拉鲁肽每日剂量达2毫克时耐受性良好。虽然利拉鲁肽会引起一过性胃肠道副作用，但很少影响继续治疗。利拉鲁肽作为二甲双胍的附加治疗药物，其空腹血糖改善情况优于对照组。在后一种情况下，与二甲双胍加用格列美脲相比，体重有所降低。利拉鲁肽是一种有前景的2型糖尿病治疗药物。
