protocolSection identificationModule nctId: NCT06353347, orgStudyIdInfo id: HTD1801.PCT106, briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: HighTide Biopharma Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin., conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 555, type: ESTIMATED, armsInterventionsModule interventions name: HTD1801, interventions name: Placebo, outcomesModule primaryOutcomes measure: Primary Endpoint: mean change in HbA1c, secondaryOutcomes measure: Double-blind (DB) Phase: mean change in fasting plasma glucose, secondaryOutcomes measure: DB Phase: mean change in 2-hour postprandial glucose, secondaryOutcomes measure: DB Phase: proportion of patients achieving HbA1c <7.0%, secondaryOutcomes measure: DB Phase: proportion of patients achieving HbA1c <6.5%, secondaryOutcomes measure: DB Phase: mean change in insulin sensitivity (HOMA-IR), secondaryOutcomes measure: DB Phase: mean change in low-density lipoprotein cholesterol (LDL-C), otherOutcomes measure: Open-Label Extension (OLE) Phase: mean change in HbA1c, otherOutcomes measure: OLE Phase: mean change in 2-Hour postprandial glucose, otherOutcomes measure: OLE Phase: proportion of patients achieving HbA1c <7.0%, otherOutcomes measure: OLE Phase: proportion of patients achieving HbA1c <6.5%, otherOutcomes measure: OLE Phase: mean change in insulin sensitivity (HOMA-IR), otherOutcomes measure: OLE Phase: mean change in LDL-C, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baogang Hospital of Inner Mongolia, status: RECRUITING, city: Baotou, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Luhe Hospital Capital Medical University, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Pinggu Hospital, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Second Norman Bethune Hospital of Jilin University, status: RECRUITING, city: Changchun, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: The First People's Hospital of Changde City, status: RECRUITING, city: Changde, country: China, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Hunan Provincial People's Hospital, status: RECRUITING, city: Changsha, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The Third Xiangya Hospital of Central South University, status: RECRUITING, city: Changsha, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Chongqing University Three Gorges Hospital, status: RECRUITING, city: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The Third People's Hospital of Datong, status: RECRUITING, city: Datong, country: China, geoPoint lat: 40.09361, lon: 113.29139, locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Handan First Hospital, status: RECRUITING, city: Handan, country: China, geoPoint lat: 36.60056, lon: 114.46778, locations facility: The Fourth Affiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: Anhui Provincial Hospital, status: RECRUITING, city: Hefei, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The Second Hospital of Anhui Medical University, status: RECRUITING, city: Hefei, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Hengshui People's Hospital (Harrison International Peace Hospital), status: RECRUITING, city: Hengshui, country: China, geoPoint lat: 37.73222, lon: 115.70111, locations facility: Heze Municipal Hospital, status: RECRUITING, city: Heze, country: China, geoPoint lat: 35.23929, lon: 115.47358, locations facility: Huai'an First People's Hospital, status: RECRUITING, city: Huai'an, country: China, geoPoint lat: 33.50389, lon: 119.14417, locations facility: Huangshi Central Hospital, status: RECRUITING, city: Huangshi, country: China, geoPoint lat: 30.24706, lon: 115.04814, locations facility: Huizhou Municipal Central Hospital, status: RECRUITING, city: Huizhou, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Huzhou Central Hospital, status: RECRUITING, city: Huzhou, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: Jinan Central Hospital, status: RECRUITING, city: Jinan, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Jingzhou Central Hospital, status: RECRUITING, city: Jingzhou, country: China, geoPoint lat: 30.35028, lon: 112.19028, locations facility: Jinzhou Central Hospital, status: RECRUITING, city: Jinzhou, country: China, geoPoint lat: 41.10778, lon: 121.14167, locations facility: The First People's Hospital of Kashgar, status: RECRUITING, city: Kashgar, country: China, geoPoint lat: 39.47066, lon: 75.98951, locations facility: Hebei Petro China Center Hospital, status: RECRUITING, city: Langfang, country: China, geoPoint lat: 39.50972, lon: 116.69472, locations facility: Liaocheng People's Hospital, status: RECRUITING, city: Liaocheng, country: China, geoPoint lat: 36.45596, lon: 115.97766, locations facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua), status: RECRUITING, city: Luoyang, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan), status: RECRUITING, city: Luoyang, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nanjing Jiangning Hospital, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Sir Run Run Hospital Nanjing Medical University, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The First People's Hospital of Nanning, status: RECRUITING, city: Nanning, country: China, geoPoint lat: 22.81667, lon: 108.31667, locations facility: The First Affiliated Hospital of Nanyang Medical College, status: RECRUITING, city: Nanyang, country: China, geoPoint lat: 32.99472, lon: 112.53278, locations facility: Panjin Liaohe Oilfield Gem Flower Hospital, status: RECRUITING, city: Panjin, country: China, geoPoint lat: 41.121, lon: 122.0739, locations facility: The First Hospital of Qiqihar, status: RECRUITING, city: Qiqihar, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: Shanghai East Hospital of Tongji University, status: RECRUITING, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Pudong New Area People's Hospital, status: RECRUITING, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shengjing Hospital of China Medical University, status: RECRUITING, city: Shenyang, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The Sixth People's Hospital of Shenyang, status: RECRUITING, city: Shenyang, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shenzhen People's Hospital, status: RECRUITING, city: Shenzhen, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: The University of Hong Kong - Shenzhen Hospital, status: RECRUITING, city: Shenzhen, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Taihe Hospital, status: RECRUITING, city: Shiyan, country: China, geoPoint lat: 32.6475, lon: 110.77806, locations facility: Siping City Central People's Hospital, status: RECRUITING, city: Siping, country: China, geoPoint lat: 43.16143, lon: 124.37785, locations facility: The First Affiliated Hospital of Suzhou University, status: RECRUITING, city: Suzhou, country: China, geoPoint lat: 31.30408, lon: 120.59538, locations facility: People's Hospital of Tianjin, status: RECRUITING, city: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Tonghua Central Hospital, status: RECRUITING, city: Tonghua, country: China, geoPoint lat: 41.71972, lon: 125.92639, locations facility: The Central Hospital of Wuhan, status: RECRUITING, city: Wuhan, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Yijishan Hospital of Wannan Medical College, status: RECRUITING, city: Wuhu, country: China, geoPoint lat: 31.33728, lon: 118.37351, locations facility: The First People's Hospital of Xiangtan City, status: RECRUITING, city: Xiangtan, country: China, geoPoint lat: 27.85, lon: 112.9, locations facility: The Affiliated Hospital of Xuzhou Medical University, status: RECRUITING, city: Xuzhou, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Yanan University Affiliated Hospital, status: RECRUITING, city: Yanan, country: China, locations facility: Yueyang People's Hospital, status: RECRUITING, city: Yueyang, country: China, geoPoint lat: 29.37455, lon: 113.09481, locations facility: Yuncheng Central Hospital, status: RECRUITING, city: Yuncheng, country: China, geoPoint lat: 35.02306, lon: 110.99278, locations facility: The Second Affiliated Hospital of Zhengzhou University, status: RECRUITING, city: Zhengzhou, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Affiliated Hospital of Jiangsu University, status: RECRUITING, city: Zhenjiang, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Zhumadian Central Hospital, status: RECRUITING, city: Zhumadian, country: China, geoPoint lat: 32.97944, lon: 114.02944, locations facility: Zhuzhou Central Hospital, status: RECRUITING, city: Zhuzhou, country: China, geoPoint lat: 27.83333, lon: 113.15, locations facility: Zibo Central Hospital, status: RECRUITING, city: Zibo, country: China, geoPoint lat: 36.79056, lon: 118.06333, locations facility: The First People's Hospital of Zunyi, status: RECRUITING, city: Zunyi, country: China, geoPoint lat: 27.68667, lon: 106.90722, hasResults: False