On April 9, 2021, the results of a phase IIIa Trial of the Mulberry Twig Alkaloids Tablet, an original natural hypoglycemic drug, were published in Diabetes Care. This article, entitled“Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Patients with Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy and Parallel Controlled Clinical Trial”, was co-authored by Peking Union Medical College Hospital, the Institute of Materia Medica of Chinese Academy of Medical Sciences and more than 20 clinical institutions.
The Mulberry Twig Alkaloids Tablet, is not only the world's first natural hypoglycemic drug originated from the active components of plants for type 2 Diabetes, but also an achievement for the original new drug guided by the concept with combination of traditional Chinese and Western medicine. Importantly, its patents have been authorized by multiple countries, such as China, United States, Japan and Canada. This drug was co-developed by Pro. Yuling Liu and Pro. Zhufang Shen from Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College for 21 years. Moreover, it was supported by multiple provincial and ministerial funds.
The phase IIIa clinical trial of the Mulberry Twig Alkaloids Tablet (SZ-A) was a randomized, double-blind study, comparing the efficacy with the chemical drug head-to-head. This study was led by Prof. Liang Xiaochun and Prof. Tian Guoqing from Peking Union Medical College Hospital, and a total of 23 institutions have participated in this trial. In this study, the “gold standard” glycosylated hemoglobin (HbA1C) was adopted as the primary outcome indicator.A total of 600 subjects were enrolled (including 360 in the SZ-A group and 240 in the acarbose group). The results showed that SZ-A significantly reduced HbA1C by 0.93%, and achieved the target with a rate of reaching the standard of 47.7%. The hypoglycemic effects of SZ-A were comparable to the acarbose group, whereas its gastrointestinal adverse reactions were dramatically decreased by nearly half. Pharmacological studies showed that SZ-A exhibited multiple pharmacological effects, such as selectively inhibiting the intestinal α-glucoside enzymes, promoting GLP-1 secretion, protecting the pancreatic β cells, improving insulin resistance and modulating the gut micro-ecological balance. Apart from its hypoglycemic effect, SZ-As was able to regulate blood lipids and reduce body weight while bear no risk of hyperglycemia, and had potential renal and cardiovascular benefits.
