Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark The Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark
Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark Steno Diabetes Center, Gentofte, Denmark.
Diabetes Care. 2015 Dec;38(12):2250-7. doi: 10.2337/dc15-1037. Epub 2015 Oct 20.
This study investigated the efficacy and safety of once-daily liraglutide 1.2 mg versus placebo as add-on to insulin treatment in normal-weight patients with poorly controlled type 1 diabetes.
In a randomized (1:1), double-blind, placebo-controlled design, 40 patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks. Continuous glucose monitoring was performed before and at the end of treatment. The primary end point was change in HbA1c. Secondary end points included change in insulin dose, weight, glycemic excursions, heart rate, and blood pressure.
Baseline HbA1c was similar in the liraglutide and placebo group (8.8 ± 0.2 and 8.7 ± 0.1% [72.5 ± 2.2 and 71.8 ± 1.5 mmol/mol]). Change in HbA1c from baseline was -0.6 ± 0.2% (-6.22 ± 1.71 mmol/mol) with liraglutide and -0.5 ± 0.2% (-5.56 ± 1.67 mmol/mol) with placebo (P = 0.62). Variation in glycemic excursions did not change in either group. Change in body weight was -3.13 ± 0.58 and +1.12 ± 0.42 kg (P < 0.0001) with liraglutide and placebo, respectively. The bolus insulin dose decreased in liraglutide-treated patients and did not change with placebo treatment (4.0 ± 1.3 vs. 0.0 ± 1.0 IU, P = 0.02). Heart rate increased within the liraglutide group (P = 0.04) but not compared with placebo, whereas mean systolic blood pressure decreased compared with placebo (between-group difference 3.21 mmHg [95% CI -8.31 to 1.90], P = 0.04). Liraglutide was more frequently associated with gastrointestinal adverse effects. The incidence of hypoglycemia did not differ between groups.
Liraglutide significantly reduces body weight and insulin requirements but has no additional effect on HbA1c in normal-weight patients with type 1 diabetes inadequately controlled on insulin alone.
本研究旨在探究每日一次利拉鲁肽 1.2mg 相较于安慰剂作为附加疗法应用于血糖控制不佳的正常体重 1 型糖尿病患者的疗效和安全性。
采用随机（1:1）、双盲、安慰剂对照设计，将 40 例 1 型糖尿病患者（HbA1c≥8%[64mmol/mol]）分为两组，分别接受每日一次利拉鲁肽 1.2mg 或安慰剂治疗 12 周。治疗前后进行连续血糖监测。主要终点为 HbA1c 的变化。次要终点包括胰岛素剂量、体重、血糖波动、心率和血压的变化。
利拉鲁肽组和安慰剂组的基线 HbA1c 相似（8.8±0.2% 和 8.7±0.1%[72.5±2.2 和 71.8±1.5mmol/mol]）。与基线相比，利拉鲁肽组 HbA1c 降低了-0.6±0.2%（-6.22±1.71mmol/mol），安慰剂组降低了-0.5±0.2%（-5.56±1.67mmol/mol）（P=0.62）。两组的血糖波动变化均无显著差异。体重变化方面，利拉鲁肽组减轻了-3.13±0.58kg，安慰剂组增加了+1.12±0.42kg（P<0.0001）。利拉鲁肽组患者的餐时胰岛素剂量减少，而安慰剂组无变化（4.0±1.3 vs. 0.0±1.0IU，P=0.02）。利拉鲁肽组的心率升高（P=0.04），但与安慰剂组相比无显著差异，而平均收缩压较安慰剂组降低（组间差异 3.21mmHg[95%CI-8.31 至 1.90]，P=0.04）。利拉鲁肽更常引起胃肠道不良反应。两组低血糖的发生率无差异。
在单独应用胰岛素血糖控制不佳的正常体重 1 型糖尿病患者中，利拉鲁肽可显著降低体重和胰岛素需求，但对 HbA1c 无额外作用。
