Liraglutide, a once-daily human glucagon-like peptide 1 analogue, provides sustained improvements in glycaemic control and weight for 2 years as monotherapy compared with glimepiride in patients with type 2 diabetes.
Liraglutide, a once-daily human glucagon-like peptide 1 analogue, provides sustained improvements in glycaemic control and weight for 2 years as monotherapy compared with glimepiride in patients with type 2 diabetes.
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DOI：
10.1111/j.1463-1326.2010.01356.x
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发表时间：
2011-04
期刊：
影响因子：
--
通讯作者：
LEAD-3 (Mono) Study Group
中科院分区：
文献类型：
--
作者：
Garber A;Henry RR;Ratner R;Hale P;Chang CT;Bode B;LEAD-3 (Mono) Study Group
目的：大多数2型糖尿病的治疗随着时间的推移而失败，需要联合治疗。我们研究了利拉鲁肽单药治疗与格列美脲单药治疗的安全性、耐受性和疗效，为期2年。方法：受试者随机接受每日一次利拉鲁肽1.2 mg、利拉鲁肽1.8 mg或格列美脲8 mg。完成1年随机化、双盲、双模拟期的受试者可以继续开放标签治疗一年。评价了暴露于治疗的完整人群的安全性数据，并评价了完整意向治疗（ITT）和2年完成者人群的疗效数据。结果指标包括糖化血红蛋白（HbA 1c）、空腹血糖（FPG）、体重以及恶心和低血糖发生频率的变化。结果如下：对于完成2年治疗的患者，格列美脲组HbA 1c降低为-0.6%，利拉鲁肽1.2 mg组为-0.9%（差异：−0.37，95% CI：−0.71至−0.02; p = 0.0376）和利拉鲁肽1.8 mg组为−1.1%（差异：−0.55，95% CI：−0.88至−0.21; p = 0.0016）。在ITT人群中，格列美脲组HbA 1c降低为-0.3%，利拉鲁肽1.2 mg组为-0.6%（差异：-0.31，95% CI：-0.54至-0.08; p = 0.0076），利拉鲁肽1.8 mg组为-0.9%（差异：-0.60，95% CI：-0.83至-0.38; p < 0.0001）。对于ITT和完成者人群，利拉鲁肽在降低HbA 1c、FPG和体重方面更有效。2年后，利拉鲁肽1.2 mg和1.8 mg组的轻度低血糖[自我治疗血糖<3.1 mmol/l（<56 mg/dl）]发生率显著低于格列美脲组（p < 0.0001）。结论：与格列美脲单药治疗相比，利拉鲁肽单药治疗2年可显著持续改善血糖控制和体重，且低血糖风险较低。
Aims: Most treatments for type 2 diabetes fail over time, necessitating combination therapy. We investigated the safety, tolerability and efficacy of liraglutide monotherapy compared with glimepiride monotherapy over 2 years. Methods: Participants were randomized to receive once-daily liraglutide 1.2 mg, liraglutide 1.8 mg or glimepiride 8 mg. Participants completing the 1-year randomized, double-blind, double-dummy period could continue open-label treatment for an additional year. Safety data were evaluated for the full population exposed to treatment, and efficacy data were evaluated for the full intention-to-treat (ITT) and 2-year completer populations. Outcome measures included change in glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and frequency of nausea and hypoglycaemia. Results: For patients completing 2 years of therapy, HbA1c reductions were −0.6% with glimepiride versus −0.9% with liraglutide 1.2 mg (difference: −0.37, 95% CI: −0.71 to −0.02; p = 0.0376) and −1.1% with liraglutide 1.8 mg (difference: −0.55, 95% CI: −0.88 to −0.21; p = 0.0016). In the ITT population, HbA1c reductions were −0.3% with glimepiride versus −0.6% with liraglutide 1.2 mg (difference: −0.31, 95% CI: −0.54 to −0.08; p = 0.0076) and −0.9% with liraglutide 1.8 mg (difference: −0.60, 95% CI: −0.83 to −0.38; p < 0.0001). For both ITT and completer populations, liraglutide was more effective in reducing HbA1c, FPG and weight. Over 2 years, rates of minor hypoglycaemia [self-treated plasma glucose <3.1 mmol/l (<56 mg/dl)] were significantly lower with liraglutide 1.2 mg and 1.8 mg compared with glimepiride (p < 0.0001). Conclusion: Liraglutide monotherapy for 2 years provides significant and sustained improvements in glycaemic control and body weight compared with glimepiride monotherapy, at a lower risk of hypoglycaemia.
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影响因子：
168.9
作者：
Turner, RC;Holman, RR;Ward, JD
通讯作者：
Ward, JD
影响因子：
5.8
作者：
Rosenstock, J.;Niggli, M.;Maldonado-Lutomirsky, M.
通讯作者：
Maldonado-Lutomirsky, M.
影响因子：
168.9
作者：
Buse, John B.;Rosenstock, Julio;Blonde, Lawrence
通讯作者：
Blonde, Lawrence
影响因子：
16.2
作者：
Zinman B;Gerich J;Buse JB;Lewin A;Schwartz S;Raskin P;Hale PM;Zdravkovic M;Blonde L;LEAD-4 Study Investigators
通讯作者：
LEAD-4 Study Investigators
影响因子：
3.2
作者：
Buse, John B.;Klonoff, David C.;Wintle, Matthew E.
通讯作者：
Wintle, Matthew E.