Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

551

Participants

Timeline

Start Date

November 13, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

December 31, 2025

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

HTD1801

HTD1801 1000 mg administered orally BID as four capsules

DRUG

Placebo

Matching placebo administered orally BID as four capsules

Trial Locations (64)

Unknown

Baogang Hospital of Inner Mongolia, Baotou

Beijing Friendship Hospital, Capital Medical University, Beijing

Beijing Luhe Hospital Capital Medical University, Beijing

Beijing Pinggu Hospital, Beijing

Peking Union Medical College Hospital, Beijing

Peking University People's Hospital, Beijing

The Second Norman Bethune Hospital of Jilin University, Changchun

The First People's Hospital of Changde City, Changde

Hunan Provincial People's Hospital, Changsha

The Third Xiangya Hospital of Central South University, Changsha

Chongqing University Three Gorges Hospital, Chongqing

The Third People's Hospital of Datong, Datong

Nanfang Hospital, Southern Medical University, Guangzhou

Handan First Hospital, Handan

The Fourth Affiliated Hospital of Harbin Medical University, Harbin

Anhui Provincial Hospital, Hefei

The Second Hospital of Anhui Medical University, Hefei

Hengshui People's Hospital (Harrison International Peace Hospital), Hengshui

Heze Municipal Hospital, Heze

Huai'an First People's Hospital, Huai'an

Huangshi Central Hospital, Huangshi

Huizhou Municipal Central Hospital, Huizhou

Huzhou Central Hospital, Huzhou

Jinan Central Hospital, Jinan

Jingzhou Central Hospital, Jingzhou

Jinzhou Central Hospital, Jinzhou

The First People's Hospital of Kashgar, Kashgar

Hebei Petro China Center Hospital, Langfang

Liaocheng People's Hospital, Liaocheng

The First Affiliated Hospital of Henan University of Science and Technology (Jinghua), Luoyang

The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan), Luoyang

Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School, Nanjing

Nanjing First Hospital, Nanjing

Nanjing Jiangning Hospital, Nanjing

Sir Run Run Hospital Nanjing Medical University, Nanjing

The Second Affiliated Hospital of Nanjing Medical University, Nanjing

The First People's Hospital of Nanning, Nanning

The First Affiliated Hospital of Nanyang Medical College, Nanyang

Panjin Liaohe Oilfield Gem Flower Hospital, Panjin

The First Hospital of Qiqihar, Qiqihar

Shanghai East Hospital of Tongji University, Shanghai

Shanghai Pudong New Area People's Hospital, Shanghai

Shengjing Hospital of China Medical University, Shenyang

The Sixth People's Hospital of Shenyang, Shenyang

Shenzhen People's Hospital, Shenzhen

The University of Hong Kong - Shenzhen Hospital, Shenzhen

Taihe Hospital, Shiyan

Siping City Central People's Hospital, Siping

The First Affiliated Hospital of Suzhou University, Suzhou

People's Hospital of Tianjin, Tianjin

Tonghua Central Hospital, Tonghua

The Central Hospital of Wuhan, Wuhan

Yijishan Hospital of Wannan Medical College, Wuhu

The First People's Hospital of Xiangtan City, Xiangtan

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

Yanan University Affiliated Hospital, Yanan

Yueyang People's Hospital, Yueyang

Yuncheng Central Hospital, Yuncheng

The Second Affiliated Hospital of Zhengzhou University, Zhengzhou

Affiliated Hospital of Jiangsu University, Zhenjiang

Zhumadian Central Hospital, Zhumadian

Zhuzhou Central Hospital, Zhuzhou

Zibo Central Hospital, Zibo

The First People's Hospital of Zunyi, Zunyi

All Listed Sponsors
lead

HighTide Biopharma Pty Ltd

INDUSTRY

NCT06353347 - Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin | Biotech Hunter | Biotech Hunter