At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 551 enrolled
Drug / intervention
HTD1801 +1 moredrug
Likely dose
HTD1801 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating HTD1801 and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 551 participants across 64 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesChina
CollaboratorsShenzhen HighTide Biopharmaceutical Ltd.
Timeline
Phase 3CompletedFinished
202420252026
Enrollment StartNov 2023
First PostedApr 2024
Primary CompletionDec 2024
Study CompletionJul 2025
TodayJul 2026
First PostedApr 9, 2024
Enrollment StartNov 13, 2023
Primary CompletionDec 12, 2024
Study CompletionJul 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.2 years ago
Interventions
HTD1801drug
HTD1801 1000 mg administered orally BID as four capsules
Placebodrug
Matching placebo administered orally BID as four capsules