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

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 (HbA_1c) 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.