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NCT06411275Completed

A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Diet and Exercise
HighTide Biopharma Pty LtdPhase 2ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
HTD1801
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
HighTide Biopharma Pty Ltd
Location
Beijing,Chang chun,Changde,Harbin,Huizhou,Jinan,Liaocheng,Luoyang,Nanjing,Nanjing,Nanjing,Nanyang,Yanan,Zhenjiang, China
Timeline & enrollment
Phase
Phase 2
Start date
Mar 31, 2022
End date
Jan 17, 2023
Enrollment
113 participants
Primary outcome

Mean change in HbA1c

Summary

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

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
NCT06411275
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06411275 through Pure Global AI's free database. This Phase 2 trial is sponsored by HighTide Biopharma Pty Ltd and is currently Completed. The study focuses on Type 2 Diabetes Mellitus. Target enrollment is 113 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.