Abstract
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.
Highlights
Diabetes is one of the largest global health emergencies of the 21st century
In the study of blood glucose of normal mice after loading sucrose, the results showed that the SZ-A in the dosage of 10 mg/kg–40 mg/kg can significantly reduce elevated blood glucose, and the blood glucose area under the curve was significantly less than acarbose group
Eligible patients in the study were 18–70 years of age, with a diagnosis of type 2 diabetes according to the 1999 World Health Organization diagnostic criteria, who were not on a regimen of antidiabetic medical treatment at least 3 months before screening, who were on a regimen of antidiabetic treatment no more than 3 months at any time in the past, who were on a stable regimen of metformin monotherapy for at least 8 weeks, and who had a glycated hemoglobin concentration (HbA1c) ≥7.0% (53 mmol/mol) and ≤10.0% (86 mmol/mol), a fasting plasma glucose level ≤13 mmol/L (234 mg/dL), and a body mass index (BMI) of 19–30 kg/m2
Summary
Diabetes is one of the largest global health emergencies of the 21st century. Diabetes and its complications are the leading causes of death. The scary number of diabetes has been increasing in most regions. In 2015, 415 million adults are estimated to currently have diabetes and 318 million adults with impaired glucose tolerance in the world [1]. Due to the cost of essential medicines, diabetes has a substantial economic impact on individuals, their families, and national health systems [1]. In addition to public health education and early diagnosis, effective treatment of diabetes is the indispensable role in halting the rise of diabetes
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