Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
SYMPHONY-2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Evaluating the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
1 other identifier
interventional
551
1 country
64
Brief Summary
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Nov 2023
64 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
November 13, 2023
CompletedFirst Submitted
Initial submission to the registry
April 3, 2024
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2025
CompletedNovember 26, 2025
November 1, 2025
1.1 years
April 3, 2024
November 19, 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)
Double-blind (DB) Phase: mean change in fasting plasma glucose
24 Weeks
DB Phase: mean change in 2-hour postprandial glucose
24 Weeks
DB Phase: proportion of patients achieving HbA1c <7.0%
24 Weeks
DB Phase: proportion of patients achieving HbA1c <6.5%
24 Weeks
DB Phase: mean change in insulin sensitivity (HOMA-IR)
24 Weeks
- +1 more secondary outcomes
Other Outcomes (6)
Open-Label Extension (OLE) Phase: mean change in HbA1c
52 Weeks
OLE Phase: mean change in 2-Hour postprandial glucose
52 Weeks
OLE Phase: proportion of patients achieving HbA1c <7.0%
52 Weeks
- +3 more other outcomes
Study Arms (2)
HTD1801
EXPERIMENTALAdministered orally twice daily (BID)
Placebo
PLACEBO COMPARATORAdministered orally BID
Interventions
Eligibility Criteria
You may qualify if:
- Have been diagnosed with type 2 diabetes
- 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 to ≤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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Baogang Hospital of Inner Mongolia
Baotou, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Luhe Hospital Capital Medical University
Beijing, China
Beijing Pinggu Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Second Norman Bethune Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
Hunan Provincial People's Hospital
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Chongqing University Three Gorges Hospital
Chongqing, China
The Third People's Hospital of Datong
Datong, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Handan First Hospital
Handan, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
Anhui Provincial Hospital
Hefei, China
The Second Hospital of Anhui Medical University
Hefei, China
Hengshui People's Hospital (Harrison International Peace Hospital)
Hengshui, China
Heze Municipal Hospital
Heze, China
Huai'an First People's Hospital
Huai'an, China
Huangshi Central Hospital
Huangshi, China
Huizhou Municipal Central Hospital
Huizhou, China
Huzhou Central Hospital
Huzhou, China
Jinan Central Hospital
Jinan, China
Jingzhou Central Hospital
Jingzhou, China
Jinzhou Central Hospital
Jinzhou, China
The First People's Hospital of Kashgar
Kashgar, China
Hebei Petro China Center Hospital
Langfang, China
Liaocheng People's Hospital
Liaocheng, China
The First Affiliated Hospital of Henan University of Science and Technology (Jinghua)
Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan)
Luoyang, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Nanjing First Hospital
Nanjing, China
Nanjing Jiangning Hospital
Nanjing, China
Sir Run Run Hospital Nanjing Medical University
Nanjing, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
The First People's Hospital of Nanning
Nanning, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
Panjin Liaohe Oilfield Gem Flower Hospital
Panjin, China
The First Hospital of Qiqihar
Qiqihar, China
Shanghai East Hospital of Tongji University
Shanghai, China
Shanghai Pudong New Area People's Hospital
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The Sixth People's Hospital of Shenyang
Shenyang, China
Shenzhen People's Hospital
Shenzhen, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, China
Taihe Hospital
Shiyan, China
Siping City Central People's Hospital
Siping, China
The First Affiliated Hospital of Suzhou University
Suzhou, China
People's Hospital of Tianjin
Tianjin, China
Tonghua Central Hospital
Tonghua, China
The Central Hospital of Wuhan
Wuhan, China
Yijishan Hospital of Wannan Medical College
Wuhu, China
The First People's Hospital of Xiangtan City
Xiangtan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Yanan University Affiliated Hospital
Yanan, China
Yueyang People's Hospital
Yueyang, China
Yuncheng Central Hospital
Yuncheng, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Affiliated Hospital of Jiangsu University
Zhenjiang, China
Zhumadian Central Hospital
Zhumadian, China
Zhuzhou Central Hospital
Zhuzhou, China
Zibo Central Hospital
Zibo, China
The First People's Hospital of Zunyi
Zunyi, China
MeSH Terms
Conditions
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
April 3, 2024
First Posted
April 9, 2024
Study Start
November 13, 2023
Primary Completion
December 12, 2024
Study Completion
July 30, 2025
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share