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Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

NCT06415773 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2025-12-31

No results posted yet for this study

Summary

The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Interventions

DRUG

HTD1801

HTD1801 1000 mg BID administered orally BID as four capsules

DRUG

Dapagliflozin

Dapagliflozin 10 mg tablet administered orally QD

Sponsors & Collaborators

  • Shenzhen HighTide Biopharmaceutical Ltd.

    collaborator UNKNOWN

  • HighTide Biopharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Kui Liu, MD · Shenzhen HighTide Biopharmaceutical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2025-06-13
Completion
2025-07-25

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06415773 on ClinicalTrials.gov