Diabetes Institute, Florida Hospital, Orlando, Florida, USA.
Diabetes Care. 2012 Oct;35(10):1986-93. doi: 10.2337/dc11-2113. Epub 2012 Jul 30.
To assess the efficacy and safety of switching from sitagliptin to liraglutide in metformin-treated adults with type 2 diabetes.
In an open-label trial, participants randomized to receive either liraglutide (1.2 or 1.8 mg/day) or sitagliptin (100 mg/day), each added to metformin, continued treatment for 52 weeks. In a 26-week extension, sitagliptin-treated participants were randomly allocated to receive instead liraglutide at either 1.2 or 1.8 mg/day, while participants originally randomized to receive liraglutide continued unchanged.
Although 52 weeks of sitagliptin changed glycosylated hemoglobin (HbA(1c)) by -0.9% from baseline, additional decreases occurred after switching to liraglutide (1.2 mg/day, -0.2%, P = 0.006; 1.8 mg/day, -0.5%, P = 0.0001). Conversion to liraglutide was associated with reductions in fasting plasma glucose (FPG) (1.2 mg/day, -0.8 mmol/L, P = 0.0004; 1.8 mg/day, -1.4 mmol/L, P < 0.0001) and body weight (1.2 mg/day, -1.6 kg; 1.8 mg/day, -2.5 kg; both P < 0.0001) and with an increased proportion of patients reaching HbA(1c) <7% (from ∼30% to ∼50%). Overall treatment satisfaction, assessed by the Diabetes Treatment Satisfaction Questionnaire, improved after switching to liraglutide (pooled 1.2 and 1.8 mg/day, 1.3; P = 0.0189). After switching, mostly transient nausea occurred in 21% of participants, and minor hypoglycemia remained low (3-4% of participants). Continuing liraglutide treatment at 1.2 mg/day and 1.8 mg/day for 78 weeks reduced HbA(1c) (baseline 8.3 and 8.4%, respectively) by -0.9 and -1.3%, respectively; FPG by -1.3 and -1.7 mmol/L, respectively; and weight by -2.6 and -3.1 kg, respectively, with 9-10% of participants reporting minor hypoglycemia.
Glycemic control, weight, and treatment satisfaction improved after switching from sitagliptin to liraglutide, albeit with a transient increase in gastrointestinal reactions.
评估在接受二甲双胍治疗的 2 型糖尿病成人中,从西格列汀转换为利拉鲁肽的疗效和安全性。
在一项开放标签试验中,参与者被随机分配接受利拉鲁肽(1.2 或 1.8mg/天)或西格列汀(100mg/天)治疗,两者均联合二甲双胍治疗 52 周。在 26 周的扩展期,接受西格列汀治疗的参与者被随机分配接受 1.2 或 1.8mg/天的利拉鲁肽治疗,而最初随机接受利拉鲁肽治疗的参与者继续不变。
虽然 52 周的西格列汀治疗使糖化血红蛋白(HbA1c)从基线水平降低了-0.9%,但转换为利拉鲁肽后还会发生进一步的降低(1.2mg/天,-0.2%,P=0.006;1.8mg/天,-0.5%,P=0.0001)。转换为利拉鲁肽与空腹血糖(FPG)的降低有关(1.2mg/天,-0.8mmol/L,P=0.0004;1.8mg/天,-1.4mmol/L,P<0.0001)和体重的降低(1.2mg/天,-1.6kg;1.8mg/天,-2.5kg;均P<0.0001),并且达到 HbA1c<7%的患者比例增加(从约 30%增加到约 50%)。通过糖尿病治疗满意度问卷评估的整体治疗满意度在转换为利拉鲁肽后得到改善(1.2mg/天和 1.8mg/天的合并数据,1.3;P=0.0189)。转换后,21%的参与者出现了主要为短暂性的恶心,而轻微的低血糖仍保持较低水平(3-4%的参与者)。继续使用利拉鲁肽治疗 78 周,分别使 HbA1c(基线分别为 8.3%和 8.4%)降低-0.9%和-1.3%;FPG 降低-1.3%和-1.7mmol/L;体重降低-2.6kg 和-3.1kg,9-10%的参与者报告有轻微的低血糖。
从西格列汀转换为利拉鲁肽后,血糖控制、体重和治疗满意度得到改善,但胃肠道反应短暂增加。