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NCT06353347Recruiting

Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

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
HighTide Biopharma Pty LtdPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Type 2 Diabetes Mellitus
Drug/Device/Intervention
HTD1801
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
HighTide Biopharma Pty Ltd
Location
Baotou,Beijing,Beijing,Beijing,Beijing,Beijing,Changchun,Changde,Changsha,Changsha,Chongqing,Datong,Guangzhou,Handan,Harbin,Hefei,Hefei,Hengshui,Heze,Huai'an,Huangshi,Huizhou,Huzhou,Jinan,Jingzhou,Jin, China
Timeline & enrollment
Phase
Phase 3
Start date
Nov 13, 2023
End date
Dec 01, 2025
Enrollment
555 participants
Primary outcome

Primary Endpoint: mean change in HbA1c

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.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06353347
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06353347 through Pure Global AI's free database. This Phase 3 trial is sponsored by HighTide Biopharma Pty Ltd and is currently Recruiting. The study focuses on Type 2 Diabetes Mellitus. Target enrollment is 555 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.