Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial

• DOI: 10.2337/dc20-2109
• Publication Date: 2021-04-08T16:29:12Z
• Authors: Ling Qu; Xiaochun Liang; Guoqing Tian; Gaili Zhang; Qunli Wu; Xiumei Huang; Yazhong Cui; Yuling Liu; Zhufang Shen; Changqing Xiao; Yingfen Qin; Heng Miao; Yongyan Zhang; Ziling Li; Shandong Ye; Xuezhi Zhang; Jing Yang; Guiwen Cao; Yi Li; Gangyi Yang; Ji Hu; Xiaoyue Wang; Zhengfang Li; Yukun Li; Xiuzhen Zhang; Guangde Zhang; Li Chen; Wenjin Hua; Ming Yu; Chunyan Lu; Xiaomei Zhang; Hong Jiang
• Keywords: Acarbose; Clinical endpoint

OBJECTIVE This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (Sangzhi [SZ-A]) in treatment type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS was a multicenter, randomized, double-blind, double-dummy, parallel controlled noninferiority clinical trial that conducted for 24 weeks. A total 600 patients were randomly allocated SZ-A group (n = 360) or acarbose 240). The primary end point change glycosylated hemoglobin (HbA1c) compared with baseline. In addition, adverse events (AEs), severe AEs (SAEs), treatment-related (TAEs), gastrointestinal disorders (GDs) monitored. RESULTS After weeks, HbA1c –0.93% (95% CI –1.03 –0.83) (–10.2 mmol/mol [–11.3 –9.1]) –0.87% (–0.99 –0.76) (–9.5 [–10.8 –8.3]) groups, respectively, least squares mean difference –0.05% –0.18 0.07) (–0.5 [–2.0 0.8]) between two no significant on basis covariance analysis (P > 0.05). incidence TAEs GDs significantly lower than < 0.01), but differences SAEs groups observed CONCLUSIONS exhibited equivalent hypoglycemic effects T2D. Nevertheless, following treatment, suggesting good safety.