Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
NCT ID: NCT06353347
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
551 participants
INTERVENTIONAL
2023-11-13
2025-07-30
Brief Summary
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Detailed Description
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Patients who complete the double-blind treatment phase will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for 28 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HTD1801
Administered orally twice daily (BID)
HTD1801
HTD1801 1000 mg administered orally BID as four capsules
Placebo
Administered orally BID
Placebo
Matching placebo administered orally BID as four capsules
Interventions
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HTD1801
HTD1801 1000 mg administered orally BID as four capsules
Placebo
Matching placebo administered orally BID as four capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shenzhen HighTide Biopharmaceutical Ltd.
UNKNOWN
HighTide Biopharma Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Kui Liu, MD
Role: STUDY_DIRECTOR
Shenzhen HighTide Biopharmaceutical Ltd.
Locations
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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
Countries
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Other Identifiers
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HTD1801.PCT106
Identifier Type: -
Identifier Source: org_study_id
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