Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

June 4, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

September 30, 2025

Conditions
T2DM (Type 2 Diabetes Mellitus)
Interventions
DRUG

HTD1801

HTD1801 1000 mg BID administered orally BID as four capsules

DRUG

Dapagliflozin

Dapagliflozin 10 mg tablet administered orally QD

Trial Locations (54)

Unknown

Beijing Pinggu Hospital, Beijing

Peking University People's Hospital, Beijing

Binzhou Medical University Hospital, Binzhou

Jilin Province FAW General Hospital, Changchun

The Second Norman Bethune Hospital of Jilin University, Changchun

The First People's Hospital of Changde City, Changde

The First Hospital of Changsha, Changsha

The Fourth Hospital of Changsha, Changsha

The Second Xiangya Hospital of Central South University, Changsha

The Third Xiangya Hospital of Central South University, Changsha

Bishan Hospital of Chongqing, Chongqing

Deyang People's Hospital, Deyang

Handan First Hospital, Handan

The Fourth Affiliated Hospital of Harbin Medical University, Harbin

Huai'an Second People's Hospital, Huai'an

Huanggang Central Hospital, Huanggang

Huangshi Central Hospital, Huangshi

Huizhou Municipal Central Hospital, Huizhou

Huzhou Central Hospital, Huzhou

Jincheng General Hospital, Jincheng

Hebei Petro China Center Hospital, Langfang

The Second People's Hospital of Lianyungang, Lianyungang

Liaocheng People's Hospital, Liaocheng

Luoyang Third People's Hospital, Luoyang

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

The First Affiliated Hospital of Nanchang University, Nanchang

The Second Affiliated Hospital of Nanchang University, Nanchang

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

The Second Affiliated Hospital of Nanjing Medical University, Nanjing

Affiliated Hospital of Nantong University, Nantong

The First Affiliated Hospital of Nanyang Medical College, Nanyang

Panjin Liaohe Oilfield Gem Flower Hospital, Panjin

Pingxiang People's Hospital, Pingxiang

The First Hospital of Qiqihar, Qiqihar

Sanmenxia Central Hospital, Sanmenxia

Huadong Hospital, Shanghai

Shanghai Sixth People's Hospital, Shanghai

Shengjing Hospital of China Medical University, Shenyang

The People's Hospital of Liaoning Province, Shenyang

Wuhan Third Hospital, Wuhan

The First Affiliated Hospital of Xi'an Jiaotong Univerity, Xi'an

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an

The First People's Hospital of Xiangtan City, Xiangtan

Xiangtan Central Hospital, Xiangtan

Xianyang Hospital of Yan'an University, Xianyang

Xuzhou Cancer Hospital, Xuzhou

The Second People's Hospital of Yibin, Yibin

Yiyang Central Hospital, Yiyang

Yueyang People's Hospital, Yueyang

Shandong Healthcare Group Zaozhuang Central Hospital, Zaozhuang

The Second Affiliated Hospital of Zhengzhou, Zhengzhou

Affiliated Hospital of Jiangsu University, Zhenjiang

Zhumadian Central Hospital, Zhumadian

All Listed Sponsors
collaborator

Shenzhen HighTide Biopharmaceutical Ltd.

UNKNOWN

lead

HighTide Biopharma Pty Ltd

INDUSTRY

NCT06415773 - Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin | Biotech Hunter | Biotech Hunter