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Abstract Title:

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.

Abstract Source:

Diabetes Care. 2021 Apr 8. Epub 2021 Apr 8. PMID: 33832957

Abstract Author(s):

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

Article Affiliation:

Ling Qu

Abstract:

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 noninferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (360) or acarbose group (240). The primary efficacy end point was the change of glycosylated hemoglobin (HbA) compared with baseline. In addition, adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs) were monitored.

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

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

Study Type : Human Study

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