Efficacy and safety of polyethylene glycol loxenatide monotherapy in type 2 diabetes patients: A multicentre, randomized, double-blind, placebo-controlled phase3aclinical trial
单位：[1]China-Japan Friendship Hospital, Beijing, China[2]Department of Endocrinology, The Second Affiliated Hospital, Chongqing MedicalUniversity, Chongqing, China[3]Department of Endocrinology, The First Affiliated Hospital of Anhui MedicalUniversity, Hefei, China[4]Department of Endocrinology, The Affiliated Hospital of Xuzhou Medical University,Xuzhou, China[5]The Center of Clinical Research of Endocrinology and Metabolic Diseases inChongqing and Department of Endocrinology, Chongqing Three Gorges CentralHospital, Chongqing, China[6]Nanjing First Hospital, Nanjing, China[7]Department of Endocrinology, People's Hospital of Hainan, Haikou, China[8]Department of Endocrinology, Central Hospital of Minhang District, MinhangHospital affiliated to Fudan University, Shanghai, China[9]The First Affiliated Hospital of Hainan Medical University, Haikou, China[10]Department of Endocrinology, The Second Affiliated Hospital of Soochow University,215004, Suzhou, China苏州大学附属第二医院[11]Department of Endocrinology Medicine, Lianyungang First People's Hospital,Affiliated Hospital of Xuzhou Medical College, Lianyungang, China
Aim To evaluate the efficacy and safety of polyethylene glycol loxenatide (PEX168) monotherapy in type 2 diabetes (T2D) patients in China. Materials and Methods In a multicentred, randomized, double-blinded, placebo-controlled phase 3a clinical trial, 361 patients with inadequate glycaemic control (HbA1c 7.0%-10.5%, fasting plasma glucose <13.9 mmol/L) were randomized (1:1:1) for weekly subcutaneous injections: placebo, PEX168/100 mu g or PEX168/200 mu g. The 24-week treatment was followed by a 28-week extension, during which placebo-treated patients were randomly assigned to PEX168/100 mu g or PEX168/200 mu g. The primary efficacy endpoint was the HbA1c change from baseline to week 24. Results The three groups had similar demographics and baseline characteristics. The HbA1c least-square mean (95% CI) change from baseline to week 24 was greater for PEX168/100 mu g (-1.02% [-1.21%, -0.83%]) and PEX168/200 mu g (-1.34% [-1.54%, -1.15%]) than for placebo (-0.17% [-0.36%, 0.02%]); (superiority:P < .0001). The proportions of patients with less than 7% HbA1c in the placebo, PEX168/100 mu g and PEX168/200 mu g groups were 15.7%, 34.7% and 46.6%, respectively. Common gastrointestinal adverse events (AEs) were nausea (5.6%, 10.0% and 0% for PEX168/100 mu g, PEX168/200 mu g and placebo, respectively) and vomiting (2.4%, 8.3% and 0% for PEX168/100 mu g, PEX168/200 mu g and placebo, respectively). Six (1.6%) patients (PEX168/100 mu g: N = 2 [1.6%], PEX168/200 mu g: N = 3 [2.5%] and placebo: N = 1 [0.8%]) discontinued treatment because of AEs. Four (1.2%) patients (PEX168/100 mu g: N = 3 [2.5%] and PEX168/200 mu g: N = 1 [0.9%]) developed PEX168 antidrug antibodies. Conclusion PEX168 monotherapy significantly improved glycaemic control in T2D patients with a safety profile resembling that of other glucagon-like peptide-1 receptor agonists.
基金：
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma)
