The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial
The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial
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DOI：
10.1007/s00125-020-05306-1
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发表时间：
2020-10-16
期刊：
影响因子：
8.2
通讯作者：
Jorgensen, Marit E.
中科院分区：
文献类型：
--
作者：
Faerch, Kristine;Blond, Martin B.;Jorgensen, Marit E.
目的/假设我们的目的是调查的短期疗效和安全性的三种降糖干预措施的超重或肥胖的个人与糖尿病前期定义的HbA（1c）。方法PRE-D试验是一个随机，对照，平行，多臂，开放标签，非盲试验，在哥本哈根，根托夫特，丹麦的Steno糖尿病中心。120名BMI >= 25 kg/m2、年龄30-70岁、糖尿病前期（HbA 1c 39-47 mmol/mol [5.7-6.4%]）的受试者按1：1：1：1的比例随机分配至达格列净（10 mg，每日一次）、二甲双胍（1700 mg，每日一次）、基于间隔的运动（5天/周，30分钟/次）或对照组（习惯性生活方式）。在基线和随机化后6、13和26周对参与者进行检查。主要结局是使用动态血糖监测系统确定的13周血糖变异性变化（计算为血糖波动的平均幅度[法师]）（预先指定的最小临床重要差异，类似于30%）。法师的30%）。结果112名参与者在13周时参加了检查，111名参与者在26周时参加了随访。与对照组相比，达格列净组的法师略有下降（17.1% [95% CI 0.7，30.8]，p = 0.042），运动组中有小幅、非显著性降低（15.3% [95% CI-1.2，29.1]，p = 0.067），而二甲双胍组的法师无变化（0.1% [95% CI-16.1，19.4]，p = 0.991）。与二甲双胍组相比，法师为17.2（95% CI 0.8，30.9;p = 0.041）达格列净组较低，15.4%（95% CI-1.1，29.1; 13周后，运动组中的P = 0.065）较低，运动组和达格列净组之间无差异（2.2% [95% CI-14.8，22.5]，p = 0.815）。一个严重的不良事件发生在对照组（肺癌）。结论/解释治疗与达格列净和基于间隔的运动导致类似的，但小的改善与控制和二甲双胍治疗相比，在血脂变异性。这些发现在糖尿病前期的临床重要性尚不确定。
Aims/hypothesis We aimed to investigate the short-term efficacy and safety of three glucose-lowering interventions in overweight or obese individuals with prediabetes defined by HbA(1c).Methods The PRE-D Trial was a randomised, controlled, parallel, multi-arm, open-label, non-blinded trial performed at Steno Diabetes Center Copenhagen, Gentofte, Denmark. One hundred and twenty participants with BMI >= 25 kg/m(2), 30-70 years of age, and prediabetes (HbA(1c)39-47 mmol/mol [5.7-6.4%]) were randomised 1:1:1:1 to dapagliflozin (10 mg once daily), metformin (1700 mg daily), interval-based exercise (5 days/week, 30 min/session) or control (habitual lifestyle). Participants were examined at baseline and at 6, 13 and 26 weeks after randomisation. The primary outcome was the 13 week change in glycaemic variability (calculated as mean amplitude of glycaemic excursions [MAGE]) determined using a continuous glucose monitoring system (pre-specified minimal clinically important difference in MAGE similar to 30%).Results One hundred and twelve participants attended the examination at 13 weeks and 111 attended the follow-up visit at 26 weeks. Compared with the control group, there was a small decrease in MAGE in the dapagliflozin group (17.1% [95% CI 0.7, 30.8],p = 0.042) and a small, non-significant, reduction in the exercise group (15.3% [95% CI -1.2, 29.1],p = 0.067), whereas MAGE was unchanged in the metformin group (0.1% [95% CI -16.1, 19.4],p = 0.991)). Compared with the metformin group, MAGE was 17.2% (95% CI 0.8, 30.9;p = 0.041) lower in the dapagliflozin group and 15.4% (95% CI -1.1, 29.1;p = 0.065) lower in the exercise group after 13 weeks, with no difference between exercise and dapagliflozin (2.2% [95% CI -14.8, 22.5],p = 0.815). One serious adverse event occurred in the control group (lung cancer).Conclusions/interpretation Treatment with dapagliflozin and interval-based exercise lead to similar but small improvements in glycaemic variability compared with control and metformin therapy. The clinical importance of these findings in prediabetes is uncertain.