Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
NCT ID: NCT06415773
Last Updated: 2025-12-31
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
367 participants
INTERVENTIONAL
2024-06-04
2025-07-25
Brief Summary
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Detailed Description
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To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 1:1 to receive HTD1801 1000 mg BID or dapagliflozin 10 mg QD.
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 BID administered orally BID as four capsules
Dapagliflozin
Administered orally once daily (QD)
Dapagliflozin
Dapagliflozin 10 mg tablet administered orally QD
Interventions
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HTD1801
HTD1801 1000 mg BID administered orally BID as four capsules
Dapagliflozin
Dapagliflozin 10 mg tablet administered orally QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
* Have a history of refractory or recurrent urinary tract infections or genital infections
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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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
Countries
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Other Identifiers
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HTD1801.PCT109
Identifier Type: -
Identifier Source: org_study_id