Xiaoping Chen1, Xiaofeng Lv2, Gangyi Yang3, Dan Lu4, Chunli Piao5, Xiaomei Zhang6, Hong Jiang7, Ying Xie8, Jinkui Yang9, Xuefeng Li10, Yanbing Li11, Xinhua Xiao12, Yukun Li13, Li Sun14, Shaoxiong Zheng15, Qingfeng Cheng16, Yongde Peng17, Wenying Yang1. 1. Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China. 2. General Hospital of Beijing Military Region, Beijing, China. 3. Department of Physical Exam Center, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China. 4. Academy of Traditional Chinese Medicine Sciences, Jilin, China. 5. Changchun University of Traditional Chinese Medicine, Changchun, China. 6. Department of Endocrinology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China. 7. The Second Affiliated Hospital of Traditional Chinese Medicine, Dalian, China. 8. Department of Endocrinology, The 2nd Affiliated Hospital, Soochow University, Suzhou, China. 9. Beijing Tongren Hospital, Capital Medical University, Beijing, China. 10. Taihe Hospital, Shiyan, China. 11. Department of Endocrinology, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China. 12. Department of Endocrinology, Xiehe Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China. 13. The Third Hospital of Hebei Medical University, Shijiazhuang, China. 14. Siping Central People's Hospital, Siping, China. 15. Department of Endocrinology and Metabolism, The Second Hospital, Tianjin Medical University, Tianjin, China. 16. Department of Physical Exam Center, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China. 17. Department of Endocrinology, Shanghai Jiaotong University Affiliated First People's Hospital, Shanghai, China.
Abstract
BACKGROUND: The aim of the present study was to evaluate the efficacy and safety of polyethylene glycol loxenatide (PEX168) injections in Chinese type 2 diabetic (T2D) patients. METHODS: The present multicenter randomized double-blind parallel placebo-controlled clinical trial enrolled patients who had been treated with a stable dose ofmetformin (≥1500 mg/day) for ≥12 weeks and had an HbA1c level between 7% and 11%. Subjects were randomly divided into three groups (1: 1: 1) and were treated with once weekly subcutaneous injections of either placebo or 100 or 200 μg PEX168 for 12 weeks. All subjects continued to receive metformin daily. RESULTS: After 12 weeks treatment, the adjusted least-squares mean of HbA1c reductions from baseline values in the 100 and 200 μg PEX168 groups were significantly higher than in the placebo group (-1.02% [95% confidence interval {CI} -1.33, -0.71), -1.36% [95% CI -1.68, -1.04], and 0.13% [95% CI -0.20, 0.45], respectively; P < 0.05). After treatment, 50% and 60.5% of subjects in the 100 and 200 μg PEX168 groups, respectively, achieved HbA1c levels <7% (P < 0.01 for both vs placebo [HbA1c 11.1%]). The most frequent adverse reactions in the PEX168 groups were mild to moderate dose-dependent gastrointestinal reactions. There were no reports of hypoglycemia or pancreatitis in any of the groups. CONCLUSIONS: Continuous 12 week treatment with PEX168 showed excellent safety and efficacy in T2D patients whose glucose was not well controlled with metformin alone.
RCT Entities:
BACKGROUND: The aim of the present study was to evaluate the efficacy and safety of polyethylene glycol loxenatide (PEX168) injections in Chinese type 2 diabetic (T2D) patients. METHODS: The present multicenter randomized double-blind parallel placebo-controlled clinical trial enrolled patients who had been treated with a stable dose of metformin (≥1500 mg/day) for ≥12 weeks and had an HbA1c level between 7% and 11%. Subjects were randomly divided into three groups (1: 1: 1) and were treated with once weekly subcutaneous injections of either placebo or 100 or 200 μg PEX168 for 12 weeks. All subjects continued to receive metformin daily. RESULTS: After 12 weeks treatment, the adjusted least-squares mean of HbA1c reductions from baseline values in the 100 and 200 μg PEX168 groups were significantly higher than in the placebo group (-1.02% [95% confidence interval {CI} -1.33, -0.71), -1.36% [95% CI -1.68, -1.04], and 0.13% [95% CI -0.20, 0.45], respectively; P < 0.05). After treatment, 50% and 60.5% of subjects in the 100 and 200 μg PEX168 groups, respectively, achieved HbA1c levels <7% (P < 0.01 for both vs placebo [HbA1c 11.1%]). The most frequent adverse reactions in the PEX168 groups were mild to moderate dose-dependent gastrointestinal reactions. There were no reports of hypoglycemia or pancreatitis in any of the groups. CONCLUSIONS: Continuous 12 week treatment with PEX168 showed excellent safety and efficacy in T2D patients whose glucose was not well controlled with metformin alone.