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Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin 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 dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled (Dapagliflozin), Parallel Group Efficacy and Safety Study of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
367
Start Date
2024-06-04
Completion Date
2025-07-25
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
HTD1801
HTD1801 1000 mg BID administered orally BID as four capsules
Dapagliflozin
Dapagliflozin 10 mg tablet administered orally QD
Locations (53)
Beijing Pinggu Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Binzhou Medical University Hospital
Binzhou, China
Jilin Province FAW General Hospital
Changchun, China
The Second Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
The First Hospital of Changsha City
Changsha, China
The Fourth Hospital of Changsha
Changsha, China
The Second Xiangya Hospital of Central South University
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Bishan Hospital of Chongqing
Chongqing, China
People's Hospital of Deyang City
Deyang, China
Handan First Hospital
Handan, China
The Fourth Hospital of Harbin Medical University
Harbin, China
The Second People's Hospital of Huai'an
Huai'an, China
Huanggang Central Hospital
Huanggang, China
Huangshi Central Hospital
Huangshi, China
Huizhou Municipal Central Hospital
Huizhou, China
Jincheng General Hospital
Jincheng, China
Hebei Petro China Central Hospital
Langfang, China
The Second People's Hospital of Lianyungang
Lianyungang, China
Liaocheng People's Hospital
Liaocheng, China
Luoyang Third People's Hospital
Luoyang, China
The First Affiliated Hospital of Henan University of Science & Technology (Jinghua)
Luoyang, China
The First Affiliated Hospital of Henan University of Science & Technology (Kaiyuan)
Luoyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
Panjin Liaohe Oilfield GEM Flower Hospital
Panjin, China
Pingxiang People's Hospital
Pingxiang, China
The First Hospital of Qiqihar
Qiqihar, China
Sanmenxia Central Hospital
Sanmenxia, China
Huadong Hospital Affiliated to Fudan University
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The People's Hospital of Liaoning Province
Shenyang, China
Wuhan Third Hospital
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Central Hospital of Xiangtan
Xiangtan, China
The First People's Hospital of Xiangtan City
Xiangtan, China
Xianyang Hospital of Yan'an University
Xianyang, China
Xuzhou Cancer Hospital
Xuzhou, China
The Second People's Hospital of Yibin
Yibin, China
Yiyang Central Hospital
Yiyang, China
Yueyang People's Hospital
Yueyang, China
Shandong Guoxinyiyang Group Zaozhuang Central Hospital
Zaozhuang, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Affiliated Hospital of Jiangsu University
Zhenjiang, China
Zhumadian Central Hospital
Zhumadian, China