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COMPLETED
NCT06353347
PHASE3

Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) 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 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

Interventions

DRUG

HTD1801

HTD1801 1000 mg administered orally BID as four capsules

DRUG

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