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Clinical Trial Details

Trial ID: L7383
Source ID: NCT06353347
Associated Drug: Htd1801
Title: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
Acronym: Symphony2
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: HTD1801|DRUG: Placebo
Outcome Measures: Primary: Primary Endpoint: mean change in HbA1c, Mean change in HbA1c from baseline to Week 24, 24 Weeks | Secondary: Double-blind (DB) Phase: mean change in fasting plasma glucose, Mean change in fasting plasma glucose from baseline to Week 24, 24 Weeks|DB Phase: mean change in 2-hour postprandial glucose, Mean change in 2-hour postprandial glucose from baseline to Week 24, 24 Weeks|DB Phase: proportion of patients achieving HbA1c <7.0%, Proportion of patients achieving HbA1c target value of \<7.0% at Week 24, 24 Weeks|DB Phase: proportion of patients achieving HbA1c <6.5%, Proportion of patients achieving HbA1c target value of \<6.5% at Week 24, 24 Weeks|DB Phase: 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|DB Phase: mean change in low-density lipoprotein cholesterol (LDL-C), Mean change in LDL-C from baseline to Week 24, 24 Weeks | Other: Open-Label Extension (OLE) Phase: mean change in HbA1c, Mean change HbA1c from baseline to Week 52, 52 Weeks|OLE Phase: mean change in 2-Hour postprandial glucose, Mean change in 2-Hour postprandial glucose from baseline to Week 52, 52 Weeks|OLE Phase: proportion of patients achieving HbA1c <7.0%, Proportion of patients achieving HbA1c target value of \<7.0% at Week 52, 52 Weeks|OLE Phase: proportion of patients achieving HbA1c <6.5%, Proportion of patients achieving HbA1c target value of \<6.5% at Week 52, 52 Weeks|OLE Phase: mean change in insulin sensitivity (HOMA-IR), Mean change in HOMA-IR from baseline to Week 52, 52 Weeks|OLE Phase: mean change in LDL-C, Mean change in LDL-C from baseline to Week 52, 52 Weeks
Sponsor/Collaborators: Sponsor: HighTide Biopharma Pty Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 551
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-13
Completion Date: 2025-12
Results First Posted:
Last Update Posted: 2024-07-01
Locations: 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
URL: https://clinicaltrials.gov/show/NCT06353347