Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial.
Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial.
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DOI：
10.1371/journal.pone.0057222
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Zhu Z
中科院分区：
文献类型：
--
作者：
Ji L;Li H;Guo X;Li Y;Hu R;Zhu Z
根据体重指数（BMI），关于选择二甲双胍作为2型糖尿病患者一线治疗的治疗建议存在差异。本研究比较了二甲双胍单药治疗在体重正常、超重和肥胖新诊断的2型糖尿病患者中的疗效。在这项前瞻性、多中心、开放标签的中国研究中，年龄23-77岁的患者按基线BMI 1∶1:1入组：正常体重（BMI 18.5 - 23.9 kg/m2, n = 125）；超重（BMI 24.0 ~ 27.9 kg/m2, n = 122）或肥胖（BMI≥28 kg/m2, n = 124）。缓释二甲双胍给予16周（500 mg/天，每周增加滴定至最大2,000 mg/天）。主要疗效终点是基线BMI对二甲双胍单药治疗血糖控制的影响，通过使用ANCOVA比较BMI组第16周时糖化血红蛋白（HbA1c）的基线变化来测量。其他终点包括比较二甲双胍对空腹血糖（FPG）、脂质水平和体重的影响。根据基线值调整后，正常体重、超重和肥胖患者的平均HbA1c在第16周下降幅度分别为-1.84%、-1.78%和-1.78% (P = 0.664)；体重分别下降2.4%、3.9%和3.5%。在所有BMI组中，FPG水平随着时间的推移相似地下降（P = 0.461），高密度脂蛋白胆固醇（HDL-C）和低密度脂蛋白胆固醇（LDL-C）的基线变化在第16周BMI组之间没有显著差异（P分别= 0.143和0.451）。基线BMI对二甲双胍单药治疗的血糖控制、体重变化或其他疗效指标没有影响。这些数据表明，正常体重的2型糖尿病患者与超重和肥胖患者一样，可以从二甲双胍一线治疗中获得相同的益处，并且体重减轻的风险不会增加。ClinicalTrials.gov NCT00778622
Differences exist between treatment recommendations regarding the choice of metformin as first-line therapy for type 2 diabetes patients according to body mass index (BMI). This study compared the efficacy of metformin monotherapy among normal-weight, overweight, and obese patients with newly diagnosed type 2 diabetes. In this prospective, multicenter, open-label study in China, patients aged 23–77 years were enrolled 1∶1:1 according to baseline BMI: normal-weight (BMI 18.5−23.9 kg/m2; n = 125); overweight (BMI 24.0−27.9 kg/m2; n = 122) or obese (BMI ≥28 kg/m2; n = 124). Extended-release metformin was administered for 16 weeks (500 mg/day, up-titrated weekly to a maximum 2,000 mg/day). The primary efficacy endpoint was the effect of baseline BMI on glycemic control with metformin monotherapy, measured as the change from baseline in glycosylated hemoglobin (HbA1c) at week 16 compared among BMI groups using ANCOVA. Other endpoints included comparisons of metformin’s effects on fasting plasma glucose (FPG), lipid levels and body weight. Mean HbA1c decreases at week 16, adjusted for baseline values, were –1.84%, –1.78% and –1.78% in normal-weight, overweight and obese patients, (P = 0.664); body weight decreased by 2.4%, 3.9% and 3.5%, respectively. FPG levels decreased similarly over time in all BMI groups (P = 0.461) and changes from baseline in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) did not differ significantly among BMI groups at week 16 (P = 0.143 and 0.451, respectively). Baseline BMI had no impact on glycemic control, weight change or other efficacy measures with metformin monotherapy. These data suggest that normal-weight type 2 diabetes patients would derive the same benefits from first-line treatment with metformin as overweight and obese patients, and are not at increased risk of excess weight loss. ClinicalTrials.gov NCT00778622
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