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Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin - Trial NCT06353347

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.

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NCT06353347
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06353347
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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

Study Focus

Type 2 Diabetes Mellitus

HTD1801

Interventional

drug

Sponsor & Location

HighTide Biopharma Pty Ltd

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 3

Nov 13, 2023

Dec 01, 2025

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 mellitus
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06353347

Non-Device Trial