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Clinical Trial Details

Trial ID: L5212
Source ID: NCT06350890
Associated Drug: Htd1801
Title: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes
Acronym: Symphony1
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: T2DM (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 values of \<7.0% at Week 24, 24 Weeks|DB Phase: Proportion of patients achieving HbA1c <6.5%, Proportion of patients achieving HbA1c target values 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 in 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 values of \<7.0% at Week 52, 52 Weeks|OLE Phase: Proportion of patients achieving HbA1c <6.5%, Proportion of patients achieving HbA1c target values 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: 408
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-05
Completion Date: 2025-09
Results First Posted:
Last Update Posted: 2024-07-01
Locations: Xuancheng People's Hospital, Xuancheng, Anhui, China|Beijing Pinggu Hospital, Beijing, Beijing, China|Fuwai Hospital, CAMS & PUMC, Beijing, Beijing, China|Peking Union Medical College Hospital, Beijing, Beijing, China|Peking University People's Hospital, Beijing, Beijing, China|Chongqing University Three Gorges Hospital, Chongqing, Chongqing, China|Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China|Huizhou Municipal Central Hospital, Huizhou, Guangdong, China|Shenzhen People's Hospital, Shenzhen, Guangdong, China|Liuzhou People's Hospital, Liuzhou, Guangxi, China|Cangzhou Central Hospital, Cangzhou, Hebei, China|Handan First Hospital, Handan, Hebei, China|Hengshui People's Hospital (Harrison International Peace Hospital), Hengshui, Hebei, China|Hebei Petro China Center Hospital, Langfang, Hebei, China|The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China|The First Hospital of Qiqihar, Qiqihar, Heilongjiang, China|The Third Affiliated Hospital of Qiqihar Medical College, Qiqihar, Heilongjiang, China|The First Affiliated Hospital of Henan University of Science and Technology (Jinghua), Luoyang, Henan, China|The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan), Luoyang, Henan, China|The First Affiliated Hospital of Nanyang Medical College, Nanyang, Henan, China|Zhumadian Central Hospital, Zhumadian, Henan, China|Huangshi Central Hospital, Huangshi, Hubei, China|Jingzhou Central Hospital, Jingzhou, Hubei, China|The Central Hospital of Wuhan, Wuhan, Hubei, China|The First People's Hospital of Changde City, Changde, Hunan, China|Hunan Provincial People's Hospital, Changsha, Hunan, China|Yueyang People's Hospital, Yueyang, Hunan, China|Baotou City Central Hospital, Baotou, Inner Mongolia, China|Inner Mongolia Autonomous Region People's Hospital, Hohhot, Inner Mongolia, China|The First People's Hospital of Changzhou, Changzhou, Jiangsu, China|Huai'an First People's Hospital, Huai'an, Jiangsu, China|The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China|Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China|Nanjing First Hospital, Nanjing, Jiangsu, China|Nanjing Jiangning Hospital, Nanjing, Jiangsu, China|Sir Run Run Hospital Nanjing Medical University, Nanjing, Jiangsu, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China|The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, China|Pingxiang People's Hospital, Pingxiang, Jiangxi, China|The Second Norman Bethune Hospital of Jilin University, Changchun, Jilin, China|Tonghua Central Hospital, Tonghua, Jilin, China|Panjin Liaohe Oilfield Gem Flower Hospital, Panjin, Liaoning, China|The Sixth People's Hospital of Shenyang, Shenyang, Liaoning, China|Qinghai Provincial People's Hospital, Xining, Qinghai, China|The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China|Jinan Central Hospital, Jinan, Shandong, China|Liaocheng People's Hospital, Liaocheng, Shandong, China|Shanghai East Hospital of Tongji University, Shanghai, Shanghai, China|The Third People's Hospital of Datong, Datong, Shanxi, China|Yuncheng Central Hospital, Yuncheng, Shanxi, China|People's Hospital of Tianjin, Tianjin, Tianjin, China|The First People's Hospital of Kashgar, Kashgar, Xinjiang, China|The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China|Huzhou Central Hospital, Huzhou, Zhejiang, China
URL: https://clinicaltrials.gov/show/NCT06350890

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