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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

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posted on 08.04.2021, 15:23 by 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
OBJECTIVE This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (sangzhi alkaloids, SZ-A) in the treatment of type 2 diabetes (T2D).

RESEARCH DESIGN AND METHODS This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled non-inferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (n=360) or acarbose group (n=240). The primary efficacy endpoint was the change of glycosylated hemoglobin (HbA1c) in comparison to baseline. In addition, adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), and gastrointestinal disorders (GDs) were monitored.

RESULTS After treatment for 24 weeks, the change in HbA1c was −0.93% (95% CI −1.03 to −0.83) (−10.2 mmol/mol, [95% CI −11.3 to −9.1]) and −0.87% (95% CI −0.99 to −0.76) (−9.5 mmol/mol, [95% CI −10.8 to −8.3]) in the SZ-A and acarbose groups, and the least squares mean difference was −0.05% (95% CI −0.18 to 0.07) (−0.5 mmol/mol, [95% CI −2.0 to 0.8]) between the two groups with no significant difference based on covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences were found for AEs or SAEs between two groups were observed (P > 0.05).

CONCLUSION SZ-A exhibited equivalent hypoglycemic effect to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than that following acarbose treatment, suggesting good safety.

Funding

This study was supported by the National Science and Technology Major Project (2013ZX09101005).

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