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A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise
Sponsor: Shenzhen HighTide Biopharmaceutical Ltd.
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Diet and Exercise
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
113
Start Date
2022-03-31
Completion Date
2023-01-17
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
HTD1801
HTD1801 administered orally BID as two capsules
Placebo
Matching placebo administered orally BID as two to four capsules
HTD1801
HTD1801 administered orally BID as four capsules
Locations (14)
Peking University People's Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
Huizhou Municipal Central Hospital
Huizhou, China
Jinan Central Hospital
Jinan, China
Liaocheng People's Hospital
Liaocheng, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Nanjing First Hospital
Nanjing, China
Nanjing Jiangning Hospital
Nanjing, China
Sir Run Run Hospital Nanjing Medical University
Nanjing, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
Yan'an University Affiliated Hospital
Yanan, China
Affiliated Hospital of Jiangsu University
Zhenjiang, China