Exenatide once weekly improved 24-hour glucose control and reduced glycaemic variability in metformin-treated participants with type 2 diabetes: a randomized, placebo-controlled trial.
Exenatide once weekly improved 24-hour glucose control and reduced glycaemic variability in metformin-treated participants with type 2 diabetes: a randomized, placebo-controlled trial.
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DOI：
10.1111/dom.12763
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发表时间：
2017-01
期刊：
影响因子：
--
通讯作者：
Strange P
中科院分区：
文献类型：
--
作者：
Frías JP;Nakhle S;Ruggles JA;Zhuplatov S;Klein E;Zhou R;Strange P
评估每周一次艾塞那肽对24小时血糖控制和变异性的影响。这项双盲、安慰剂对照试验将接受二甲双胍治疗的2型糖尿病成人随机分为每周一次exenglutin2.0 mg组或安慰剂组。在基线以及第4周和第10周进行动态血糖监测（CGM）。主要结局是CGM测量的24小时平均葡萄糖水平的变化。在每周一次的exengland组（n = 60）和安慰剂组（n = 56）（修改的意向治疗人群）中，基线糖化血红蛋白（HbA 1c）浓度分别为8.2%和8.0%，空腹血糖（FPG）浓度分别为9.86和9.32 mmol/L。与安慰剂相比，每周一次的exenetrin显著（p < 0.001）降低了24小时平均血糖水平（第4周，−1.44 vs −0.29 mmol/L;第10周，−1.71 vs −0.17 mmol/L），整个星期的控制一致。与安慰剂相比，每周一次的exenetrin在第4周（FPG，−1.65 vs −0.11 mmol/L; PPG，−1.79 vs − 0.11 mmol/L）和第10周（FPG，−2.32 vs −0.28 mmol/L; PPG，−2.46 vs −0.33 mmol/L）显著降低了FPG和餐后2小时血糖（PPG）水平。在第10周，每周一次艾塞那肽降低了血糖波动的平均幅度（法师;-0.84 vs 0.16 mmol/L）和标准差（s.d.）平均葡萄糖（-0.35 vs 0.04 mmol/L）。到第10周，每周一次艾塞那肽治疗的参与者在正常血糖中花费的时间更多（每周一次艾塞那肽，77% vs安慰剂，58%），高血糖时间更少（22% vs 42%），低血糖时间相似（0.7% vs 0.3%）。常见不良事件为注射部位结节（每周一次艾司那肽，10.0% vs安慰剂，0.0%）、尿路感染（6.7% vs 8.9%）和恶心（6.7% vs 0.0%）。在二甲双胍治疗的2型糖尿病受试者中，每周一次的exenglycine显著改善了每日血糖控制，并降低了第4周和第10周的血糖变异性，如24小时血糖、FPG和PPG水平、法师和s.d.的降低所示，并增加了处于正常状态的时间。
To assess the effects of once‐weekly exenatide on 24‐hour glucose control and variability. This double‐blind, placebo‐controlled trial randomized metformin‐treated adults with type 2 diabetes to once‐weekly exenatide 2.0 mg or placebo. Continuous glucose monitoring (CGM) was performed at baseline and weeks 4 and 10. The primary outcome was change in CGM‐measured 24‐hour mean glucose level. In the once‐weekly exenatide (n = 60) and placebo (n = 56) groups (modified intention‐to‐treat population), the baseline glycated haemoglobin (HbA1c) concentrations were 8.2% and 8.0%, respectively, and the fasting plasma glucose (FPG) concentration was 9.86 and 9.32 mmol/L, respectively. Once‐weekly exenatide significantly (p < 0.001) reduced 24‐hour mean glucose level versus placebo (week 4, −1.44 vs −0.29 mmol/L; week 10, −1.71 vs −0.17 mmol/L), with consistent control throughout the week. Once‐weekly exenatide significantly reduced FPG and 2‐hour postprandial glucose (PPG) levels versus placebo at week 4 (FPG, −1.65 vs −0.11 mmol/L; PPG, −1.79 vs −0.11 mmol/L) and week 10 (FPG, −2.32 vs −0.28 mmol/L; PPG, −2.46 vs −0.33 mmol/L). At week 10, once‐weekly exenatide reduced the mean amplitude of glucose excursions (MAGE; −0.84 vs 0.16 mmol/L) and standard deviation (s.d.) of mean glucose (−0.35 vs 0.04 mmol/L). By week 10, once‐weekly exenatide‐treated participants spent more time in euglycaemia (once‐weekly exenatide, 77% vs placebo, 58%), less time in hyperglycaemia (22% vs 42%), and a similar time in hypoglycaemia (0.7% vs 0.3%). Common adverse events were injection‐site nodule (once‐weekly exenatide, 10.0% vs placebo, 0.0%), urinary tract infection (6.7% vs 8.9%) and nausea (6.7% vs 0.0%). In metformin‐treated participants with type 2 diabetes, once‐weekly exenatide significantly improved daily glucose control and reduced glycaemic variability at weeks 4 and 10, as shown by reductions in 24‐hour glucose, FPG and PPG levels, MAGE and s.d., and increased time spent in euglycaemia.
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