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COMPLETED
NCT06411275
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

HTD1801

HTD1801 administered orally BID as two capsules

DRUG

Placebo

Matching placebo administered orally BID as two to four capsules

DRUG

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