Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi)‎ Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus

الملخص EN

Aims.

To evaluate the efficacy and safety of mulberry twig alkaloid (SZ-A) tablet compared with acarbose in patients with type 2 diabetes.

Methods.

This clinical trial enrolled 38 patients who were randomized into two groups (SZ-A: 23; acarbose: 15) and were treated for 24 weeks.

Patients and clinical trial staffs were masked to treatment assignment throughout the study.

The primary outcome measures were glycated hemoglobin (HbA1c) and 1-hour and 2-hour postprandial and fasting plasma glucose levels from baseline to the end of treatment.

Analysis included all patients who completed this study.

Results.

By the end of this study, HbA1c level in SZ-A group was decreased from baseline significantly (P<0.001).

No significant difference was found when compared with acarbose group (P=0.652).

Similarly, 1-hour and 2-hour postprandial plasma glucose levels in SZ-A group were decreased from baseline statistically (P<0.05), without any significant differences compared with acarbose group (P=0.748 and 0.558, resp.).

The fasting plasma glucose levels were not significantly changed in both groups.

One of 23 patients in SZ-A group (4.76%) and 5 of 15 patients in acarbose group (33.33%) suffered from gastrointestinal adverse events.

Conclusions.

Compared with acarbose, SZ-A tablet was effective and safe in glycemic control in patients with type 2 diabetes.