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Clinical Trial Details

Trial ID: L5800
Source ID: NCT06411275
Associated Drug: Htd1801
Title: A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: HTD1801|DRUG: Placebo|DRUG: HTD1801
Outcome Measures: Primary: Mean change in HbA1c, Mean change in HbA1c from baseline to Week 12, 12 Weeks | Secondary: Mean change in fasting plasma glucose, Mean change in fasting plasma glucose from baseline to Week 12, 12 Weeks|Proportion of patients achieving HbA1c <7.0%, Proportion of patients achieving HbA1c \<7.0% after 12 weeks of treatment, 12 Weeks|Proportion of patients achieving HbA1c <6.5%, Proportion of patients achieving HbA1c \<6.5% after 12 weeks of treatment, 12 Weeks|Mean change in postprandial glucose, Mean change in postprandial glucose from baseline to Week 12, 12 Weeks|Mean change in low-density lipoprotein cholesterol (LDL-C), Mean change in LDL-C from baseline to Week 12, 12 Weeks
Sponsor/Collaborators: Sponsor: HighTide Biopharma Pty Ltd | Collaborators: Shenzhen HighTide Biopharmaceutical Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 113
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-31
Completion Date: 2023-01-17
Results First Posted:
Last Update Posted: 2024-05-13
Locations: Peking University People's Hospital, Beijing, China|The Second Hospital of Jilin University, Chang chun, China|The First People's Hospital of Changde City, Changde, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China|Huizhou Municipal Central Hospital, Huizhou, China|Jinan Central Hospital, Jinan, China|Liaocheng People's Hospital, Liaocheng, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China|Nanjing First Hospital, Nanjing, China|Nanjing Jiangning Hospital, Nanjing, China|Sir Run Run Hospital Nanjing Medical University, Nanjing, China|The First Affiliated Hospital of Nanyang Medical College, Nanyang, China|Yan'an University Affiliated Hospital, Yanan, China|Affiliated Hospital of Jiangsu University, Zhenjiang, China
URL: https://clinicaltrials.gov/show/NCT06411275