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
1 other identifier
interventional
113
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Mar 2022
Shorter than P25 for phase_2 type-2-diabetes-mellitus
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2023
CompletedFirst Submitted
Initial submission to the registry
May 8, 2024
CompletedFirst Posted
Study publicly available on registry
May 13, 2024
CompletedMay 13, 2024
May 1, 2024
10 months
May 8, 2024
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change in HbA1c
Mean change in HbA1c from baseline to Week 12
12 Weeks
Secondary Outcomes (5)
Mean change in fasting plasma glucose
12 Weeks
Proportion of patients achieving HbA1c <7.0%
12 Weeks
Proportion of patients achieving HbA1c <6.5%
12 Weeks
Mean change in postprandial glucose
12 Weeks
Mean change in low-density lipoprotein cholesterol (LDL-C)
12 Weeks
Study Arms (3)
HTD1801 500 mg
EXPERIMENTALAdministered orally twice daily (BID)
HTD1801 1000 mg
EXPERIMENTALAdministered orally BID
Placebo
PLACEBO COMPARATORAdministered orally BID
Interventions
Eligibility Criteria
You may qualify if:
- Have been diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria
- Have followed dietary and exercise interventions for at least 8 weeks prior to screening
- Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization)
- Have fasting plasma glucose \<13.9 mmol/L (screening and pre-randomization)
- Have a body mass index ≥18 kg/m\^2 to ≤40 kg/m\^2
You may not qualify if:
- Have type 1 diabetes mellitus or specific type of diabetes mellitus (pancreatic injury-induced diabetes mellitus, diabetes mellitus caused by Cushing's syndrome or acromegaly, etc.)
- Have had diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening
- Have had 2 or more Grade 3 hypoglycemic events within 12 months prior to screening
- Have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening
- Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 4 weeks prior to screening
- Have continuously used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
- Have used 2 or more classes of hypoglycemic medications for more than 8 weeks within 12 months prior to screening
- Have used any glucose-modifying medications within 8 weeks prior to screening
- Have had weight gain or loss ≥5% from screening to randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Peking University People's Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, 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
Related Publications (1)
Ji L, Ma J, Ma Y, Cheng Z, Gan S, Yuan G, Liu D, Li S, Liu Y, Xue X, Bai J, Wang K, Cai H, Li S, Liu K, Yu M, Liu L. Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e2462185. doi: 10.1001/jamanetworkopen.2024.62185.
PMID: 40029660DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kui Liu
Shenzhen HighTide Biopharmaceutical Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
May 13, 2024
Study Start
March 31, 2022
Primary Completion
January 17, 2023
Study Completion
January 17, 2023
Last Updated
May 13, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share