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

Sponsor
HighTide Biopharma Pty Ltd
Study ID
NCT06415773
Phase
PHASE3
Status
Completed

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HTD1801 — DRUG
    HTD1801 1000 mg BID administered orally BID as four capsules
  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg tablet administered orally QD

Study Details

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.

Key Dates

Start date
Jun 4, 2024
Status verified
Dec 2025
Primary completion
Jun 13, 2025
Completion
Jul 25, 2025

Study Design

Enrollment
367 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HTD1801
    Administered orally twice daily (BID)
  • Active Comparator: Dapagliflozin
    Administered orally once daily (QD)

Primary Outcome Measure

Primary Endpoint: Mean change in HbA1c [ Time Frame: 24 Weeks ]

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