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COMPLETED
NCT06415773
PHASE3

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

Sponsor: Shenzhen HighTide Biopharmaceutical Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

HTD1801

HTD1801 1000 mg BID administered orally BID as four capsules

DRUG

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