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A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise - Trial NCT06411275

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.

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NCT06411275
Phase 2
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06411275
View on ClinicalTrials.gov
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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

Study Focus

Type 2 Diabetes Mellitus

HTD1801

Interventional

drug

Sponsor & Location

HighTide Biopharma Pty Ltd

Beijing,Chang chun,Changde,Harbin,Huizhou,Jinan,Liaocheng,Luoyang,Nanjing,Nanjing,Nanjing,Nanyang,Yanan,Zhenjiang, China

Timeline & Enrollment

Phase 2

Mar 31, 2022

Jan 17, 2023

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 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

NCT06411275

Non-Device Trial