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Clinical Trial Details

Trial ID: L2199
Source ID: NCT06415773
Associated Drug: Htd1801
Title: Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: T2DM (Type 2 Diabetes Mellitus)
Interventions: DRUG: HTD1801|DRUG: Dapagliflozin
Outcome Measures: Primary: Primary Endpoint: Mean change in HbA1c, Mean change in HbA1c from baseline to Week 24, 24 Weeks | Secondary: Mean Change in Fasting Plasma Glucose, Mean change in fasting plasma glucose from baseline to Week 24, 24 Weeks|Mean Change in 2-Hour Postprandial Glucose, Mean change in 2-hour postprandial glucose from baseline to Week 24, 24 Weeks|Proportion of Patients Achieving HbA1c <7.0%, Proportion of patients achieving HbA1c \<7.0% after 24 weeks of treatment, 24 Weeks|Proportion of Patients Achieving HbA1c <6.5%, Proportion of patients achieving HbA1c \<6.5% after 24 weeks of treatment, 24 Weeks|Mean Change in Insulin Sensitivity (HOMA-IR), Mean change in homeostatic model assessment for insulin resistance (HOMA-IR) from baseline to Week 24, 24 Weeks|Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C), Mean change in LDL-C from baseline to Week 24, 24 Weeks
Sponsor/Collaborators: Sponsor: HighTide Biopharma Pty Ltd | Collaborators: Shenzhen HighTide Biopharmaceutical Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 418
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2025-09
Results First Posted:
Last Update Posted: 2025-01-14
Locations: 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 Norman Bethune Hospital of Jilin University, Changchun, China|The First People's Hospital of Changde City, Changde, China|The First Hospital of Changsha, 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|Deyang People's Hospital, Deyang, China|Handan First Hospital, Handan, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China|Huai'an Second People's Hospital, Huai'an, China|Huanggang Central Hospital, Huanggang, China|Huangshi Central Hospital, Huangshi, China|Huizhou Municipal Central Hospital, Huizhou, China|Huzhou Central Hospital, Huzhou, China|Jincheng General Hospital, Jincheng, China|Hebei Petro China Center 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 and Technology (Jinghua), Luoyang, China|The First Affiliated Hospital of Henan University of Science and 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, 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 Univerity, Xi'an, China|The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China|The First People's Hospital of Xiangtan City, Xiangtan, China|Xiangtan Central Hospital, 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 Healthcare Group Zaozhuang Central Hospital, Zaozhuang, China|The Second Affiliated Hospital of Zhengzhou, Zhengzhou, China|Affiliated Hospital of Jiangsu University, Zhenjiang, China|Zhumadian Central Hospital, Zhumadian, China
URL: https://clinicaltrials.gov/show/NCT06415773