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Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
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 metformin.
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 Inadequately Controlled With Metformin
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
551
Start Date
2023-11-13
Completion Date
2025-07-30
Last Updated
2026-08-11
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 (64)
Baogang Hospital of Inner Mongolia
Baotou, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Luhe Hospital Capital Medical University
Beijing, China
Beijing Pinggu Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Second Norman Bethune Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
Hunan Provincial People's Hospital
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Chongqing University Three Gorges Hospital
Chongqing, China
The Third People's Hospital of Datong
Datong, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Handan First Hospital
Handan, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
Anhui Provincial Hospital
Hefei, China
The Second Hospital of Anhui Medical University
Hefei, China
Hengshui People's Hospital (Harrison International Peace Hospital)
Hengshui, China
Heze Municipal Hospital
Heze, China
Huai'an First People's Hospital
Huai'an, China
Huangshi Central Hospital
Huangshi, China
Huizhou Municipal Central Hospital
Huizhou, China
Huzhou Central Hospital
Huzhou, China
Jinan Central Hospital
Jinan, China
Jingzhou Central Hospital
Jingzhou, China
Jinzhou Central Hospital
Jinzhou, China
The First People's Hospital of Kashgar
Kashgar, China
Hebei Petro China Center Hospital
Langfang, China
Liaocheng People's Hospital
Liaocheng, China
The First Affiliated Hospital of Henan University of Science and Technology (Jinghua)
Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan)
Luoyang, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Nanjing First Hospital
Nanjing, China
Nanjing Jiangning Hospital
Nanjing, China
Sir Run Run Hospital Nanjing Medical University
Nanjing, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
The First People's Hospital of Nanning
Nanning, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
Panjin Liaohe Oilfield Gem Flower Hospital
Panjin, China
The First Hospital of Qiqihar
Qiqihar, China
Shanghai East Hospital of Tongji University
Shanghai, China
Shanghai Pudong New Area People's Hospital
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The Sixth People's Hospital of Shenyang
Shenyang, China
Shenzhen People's Hospital
Shenzhen, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, China
Taihe Hospital
Shiyan, China
Siping City Central People's Hospital
Siping, China
The First Affiliated Hospital of Suzhou University
Suzhou, China
People's Hospital of Tianjin
Tianjin, China
Tonghua Central Hospital
Tonghua, China
The Central Hospital of Wuhan
Wuhan, China
Yijishan Hospital of Wannan Medical College
Wuhu, China
The First People's Hospital of Xiangtan City
Xiangtan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Yanan University Affiliated Hospital
Yanan, China
Yueyang People's Hospital
Yueyang, China
Yuncheng Central Hospital
Yuncheng, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Affiliated Hospital of Jiangsu University
Zhenjiang, China
Zhumadian Central Hospital
Zhumadian, China
Zhuzhou Central Hospital
Zhuzhou, China
Zibo Central Hospital
Zibo, China
The First People's Hospital of Zunyi
Zunyi, China