Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
HARMONY
A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled (Dapagliflozin), Parallel Group Efficacy and Safety Study of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone
1 other identifier
interventional
367
1 country
53
Brief Summary
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2024
Shorter than P25 for phase_3
53 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
First Submitted
Initial submission to the registry
May 10, 2024
CompletedFirst Posted
Study publicly available on registry
May 16, 2024
CompletedStudy Start
First participant enrolled
June 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2025
CompletedDecember 31, 2025
December 1, 2025
1 year
May 10, 2024
December 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Endpoint: Mean change in HbA1c
Mean change in HbA1c from baseline to Week 24
24 Weeks
Secondary Outcomes (6)
Mean Change in Fasting Plasma Glucose
24 Weeks
Mean Change in 2-Hour Postprandial Glucose
24 Weeks
Proportion of Patients Achieving HbA1c <7.0%
24 Weeks
Proportion of Patients Achieving HbA1c <6.5%
24 Weeks
Mean Change in Insulin Sensitivity (HOMA-IR)
24 Weeks
- +1 more secondary outcomes
Study Arms (2)
HTD1801
EXPERIMENTALAdministered orally twice daily (BID)
Dapagliflozin
ACTIVE COMPARATORAdministered orally once daily (QD)
Interventions
HTD1801 1000 mg BID administered orally BID as four capsules
Eligibility Criteria
You may qualify if:
- Have been diagnosed with type 2 diabetes
- Have received a stable dose of metformin monotherapy for at least 8 weeks prior to screening
- If used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening
- Have HbA1c ≥7.5% to ≤11.0% (screening) and HbA1c ≥7.0% to ≤10.5% (pre-randomization)
- Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization)
- Have a body mass index ≥19.0 kg/m\^2 and ≤35.0 kg/m\^2
You may not qualify if:
- Have type 1 diabetes
- Have had any acute diabetic complications within 12 months prior to screening
- Have had any Grade 3 hypoglycemic event within 12 months prior to screening
- Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
- 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 12 weeks prior to screening
- Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
- Have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization
- Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
- Have a history of refractory or recurrent urinary tract infections or genital infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Beijing Pinggu Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Binzhou Medical University Hospital
Binzhou, China
Jilin Province FAW General Hospital
Changchun, China
The Second Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
The First Hospital of Changsha City
Changsha, China
The Fourth Hospital of Changsha
Changsha, China
The Second Xiangya Hospital of Central South University
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Bishan Hospital of Chongqing
Chongqing, China
People's Hospital of Deyang City
Deyang, China
Handan First Hospital
Handan, China
The Fourth Hospital of Harbin Medical University
Harbin, China
The Second People's Hospital of Huai'an
Huai'an, China
Huanggang Central Hospital
Huanggang, China
Huangshi Central Hospital
Huangshi, China
Huizhou Municipal Central Hospital
Huizhou, China
Jincheng General Hospital
Jincheng, China
Hebei Petro China Central Hospital
Langfang, China
The Second People's Hospital of Lianyungang
Lianyungang, China
Liaocheng People's Hospital
Liaocheng, China
Luoyang Third People's Hospital
Luoyang, China
The First Affiliated Hospital of Henan University of Science & Technology (Jinghua)
Luoyang, China
The First Affiliated Hospital of Henan University of Science & Technology (Kaiyuan)
Luoyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
Panjin Liaohe Oilfield GEM Flower Hospital
Panjin, China
Pingxiang People's Hospital
Pingxiang, China
The First Hospital of Qiqihar
Qiqihar, China
Sanmenxia Central Hospital
Sanmenxia, China
Huadong Hospital Affiliated to Fudan University
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The People's Hospital of Liaoning Province
Shenyang, China
Wuhan Third Hospital
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Central Hospital of Xiangtan
Xiangtan, China
The First People's Hospital of Xiangtan City
Xiangtan, China
Xianyang Hospital of Yan'an University
Xianyang, China
Xuzhou Cancer Hospital
Xuzhou, China
The Second People's Hospital of Yibin
Yibin, China
Yiyang Central Hospital
Yiyang, China
Yueyang People's Hospital
Yueyang, China
Shandong Guoxinyiyang Group Zaozhuang Central Hospital
Zaozhuang, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Affiliated Hospital of Jiangsu University
Zhenjiang, China
Zhumadian Central Hospital
Zhumadian, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kui Liu, MD
Shenzhen HighTide Biopharmaceutical Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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 10, 2024
First Posted
May 16, 2024
Study Start
June 4, 2024
Primary Completion
June 13, 2025
Study Completion
July 25, 2025
Last Updated
December 31, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share