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Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes
Sponsor: Shenzhen HighTide Biopharmaceutical Ltd.
Summary
The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus Who Have Poor Glycemic Control After Dietary and Exercise Interventions
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
408
Start Date
2023-11-05
Completion Date
2025-08-04
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
HTD1801
HTD1801 1000 mg administered orally BID as four capsules
Placebo
Matching placebo administered orally BID as four capsules
Locations (56)
Xuancheng People's Hospital
Xuancheng, Anhui, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Handan First Hospital
Handan, Hebei, China
Hengshui People's Hospital (Harrison International Peace Hospital)
Hengshui, Hebei, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, China
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science & Technology (Jinghua)
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology (Kaiyuan)
Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Zhumadian Central Hospital
Zhumadian, Henan, China
Huangshi Central Hospital
Huangshi, Hubei, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
The First People's Hospital of Changde City
Changde, Hunan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Yueyang People's Hospital
Yueyang, Hunan, China
Baotou City Central Hospital
Baotou, Inner Mongolia, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Sir Run Run Shaw Hospital Nanjing Medical University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Tonghua Central Hospital
Tonghua, Jilin, China
Panjin Liaohe Oilfield Gem Flower Hospital
Panjin, Liaoning, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Shanghai East Hospital of Tongji University
Shanghai, Shanghai Municipality, China
The Third People's Hospital of Datong
Datong, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, China
The First People's Hospital of Kashi
Kashgar, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Huzhou Central Hospital
Huzhou, Zhejiang, China