Background: The weight-reducing effect of exenatide has been proved, but too much weight loss in normal-weight patients may concern physicians. This study evaluated the effects of exenatide monotherapy on glycemic control and weight change in normal-weight, overweight, and obese patients with newly diagnosed type 2 diabetes (T2D).
Methods: In this multicenter prospective study, 29 normal-weight, 54 overweight, and 27 obese newly diagnosed and drug-naïve patients with T2D were treated with exenatide for 48 weeks. The primary efficacy endpoint was the effect of baseline body mass index (BMI) on glycemic control, measured as the change in HbA1c from baseline to Week 48 compared among different BMI groups. Other endpoints included comparisons of the effects of exenatide on fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body weight, and other metabolic indices.
Results: After 48-week treatment, the estimated mean changes in HbA1c in normal-weight, overweight, and obese patients were -1.9%, -1.8%, and -1.5%, respectively (P = 0.290 among groups after adjustment for baseline values). There were similar declines in FPG and 0.5- and 2-hour PPG among groups. There were non-significant trends from normal-weight to overweight to obese patients for increased weight reduction (decreases of 2.2, 3.9, and 4.0 kg, respectively; P = 0.104) and changes in waist circumference (decreases of 2.2, 3.2, and 5.6 cm, respectively; P = 0.078).
Conclusions: Baseline BMI had no effect on glycemic control, weight change, or other metabolic indices with exenatide monotherapy. Normal-weight patients with T2D would benefit from exenatide as much as overweight or obese patients on glucose control, without increased risk of excess weight loss.
背景: 艾塞那肽减重的作用已被研究证实，但医生可能会担心正常体重的患者接受艾塞那肽治疗后体重过度下降。本研究将评估艾塞那肽对正常体重、超重和肥胖的初诊2型糖尿病患者血糖控制和体重改变的影响。 方法: 在这项多中心、前瞻性临床研究中纳入了初诊且未接受过药物治疗的2型糖尿病患者，他们接受了艾塞那肽治疗48周，其中正常体重组29人，超重组54人，肥胖组27人。主要终点为基线体重指数(body mass index，BMI)对于不同BMI组患者血糖控制的影响。采用各组48周治疗后糖化血红蛋白(HbA1c)与基线HbA1c的变化值作为评估指标。其他终点包括艾塞那肽对于各组患者空腹血糖、餐后血糖、体重和其他代谢指标的影响。 结果: 经过48周的治疗，正常体重、超重和肥胖组患者的HbA1c平均下降了1.9%、1.8%和1.5%(校正了基线HbA1c水平后，组间比较P值为0.290)。各组间空腹血糖、餐后半小时血糖和餐后2小时血糖的下降情况相近。体重下降幅度和腰围下降幅度从正常体重、超重到肥胖组呈现逐渐增加的趋势，但没有达到统计学差异(体重下降分别为2.2公斤、3.9公斤和4.0公斤，P = 0.104；腰围下降分别为2.2厘米、3.2厘米和5.6厘米，P = 0.078)。 结论: 基线BMI对接受艾塞那肽单药治疗的初诊2型糖尿病患者的血糖控制、体重变化和其他代谢指标没有明显影响。正常体重的2型糖尿病患者接受艾塞那肽治疗可获得与超重、肥胖患者一样的血糖控制疗效，并且没有增加体重过度降低的风险。.
Keywords: 2型糖尿病; body weight; exenatide; type 2 diabetes; 体重; 艾塞那肽.
© 2018 The Authors. Journal of Diabetes published by John Wiley & Sons Australia, Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.