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超越血糖控制:利拉鲁肽治疗 1 型糖尿病的交叉、双盲、24 周干预研究。

Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes.

机构信息

Endocrinology and Nephrology, CHU de Québec-Université Laval, Québec, QC, Canada.

出版信息

Diabetes Obes Metab. 2018 Jan;20(1):178-184. doi: 10.1111/dom.13063. Epub 2017 Sep 6.

Abstract

AIMS

To investigate the effects of 24 weeks of treatment with liraglutide added to basal/bolus insulin on anthropometric and metabolic parameters in overweight participants with type 1 diabetes.

METHODS

In a double-blinded cross-over fashion, 15 participants were randomly assigned (1:1) to receive placebo (saline solution) or liraglutide for 24 weeks including a 1-month titration period from 0.6 to 1.2 to 1.8 mg, in addition to their insulin. The treatment was followed by a 1-month wash-out period. Participants were then assigned to the other treatment for another 24 weeks. Paired rank tests were used to compare the metabolic parameters.

RESULTS

There was no treatment effect on HbA1c nor on insulin dose. Heart rate was increased by about 8 beats per minute with liraglutide. There were significant reductions in metabolic measures: weight, body mass index, waist and hip circumferences, body fatness, computed tomography scan abdominal and mid-thigh measurements, systolic and diastolic blood pressures (all P ≤ .05). There was no increase in time spent in hypoglycaemia with liraglutide.

CONCLUSIONS

The addition of liraglutide to basal/bolus insulin therapy for 24 weeks in overweight/obese individuals with type 1 diabetes improved the anthropometric and metabolic profiles without an increase in hypoglycaemia. Clinical Trials.gov No: NCT01787916.

摘要

目的

研究在 1 型糖尿病超重患者中,基础/餐时胰岛素联合利拉鲁肽治疗 24 周对人体测量学和代谢参数的影响。

方法

采用双盲交叉设计,将 15 名参与者随机(1:1)分配接受安慰剂(生理盐水)或利拉鲁肽治疗 24 周,包括 1 个月的滴定期(从 0.6 至 1.2 再至 1.8mg),同时继续使用胰岛素。治疗后进行 1 个月的洗脱期。然后,参与者被分配到另一种治疗方案,再接受 24 周治疗。采用配对等级检验比较代谢参数。

结果

利拉鲁肽对糖化血红蛋白(HbA1c)和胰岛素剂量无治疗作用。与安慰剂相比,利拉鲁肽可使心率每分钟增加约 8 次。代谢指标有显著降低:体重、体重指数、腰围和臀围、体脂、计算机断层扫描腹部和大腿中段测量值、收缩压和舒张压(均 P≤.05)。使用利拉鲁肽治疗并未增加低血糖时间。

结论

在超重/肥胖的 1 型糖尿病患者中,基础/餐时胰岛素联合利拉鲁肽治疗 24 周可改善人体测量学和代谢特征,而不会增加低血糖风险。临床试验注册编号:NCT01787916。

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