protocolSection identificationModule nctId: NCT06350890, orgStudyIdInfo id: HTD1801.PCT105, briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-08, 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 diet and exercise alone., conditionsModule conditions: T2DM (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: 405, 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: Xuancheng People's Hospital, status: RECRUITING, city: Xuancheng, state: Anhui, country: China, geoPoint lat: 25.40949, lon: 116.3841, locations facility: Beijing Pinggu Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Fuwai Hospital, CAMS & PUMC, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing University Three Gorges Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Huizhou Municipal Central Hospital, status: RECRUITING, city: Huizhou, state: Guangdong, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Shenzhen People's Hospital, status: RECRUITING, city: Shenzhen, state: Guangdong, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Liuzhou People's Hospital, status: RECRUITING, city: Liuzhou, state: Guangxi, country: China, locations facility: Cangzhou Central Hospital, status: RECRUITING, city: Cangzhou, state: Hebei, country: China, geoPoint lat: 38.31667, lon: 116.86667, locations facility: Handan First Hospital, status: RECRUITING, city: Handan, state: Hebei, country: China, geoPoint lat: 36.60056, lon: 114.46778, locations facility: Hengshui People's Hospital (Harrison International Peace Hospital), status: RECRUITING, city: Hengshui, state: Hebei, country: China, geoPoint lat: 37.73222, lon: 115.70111, locations facility: Hebei Petro China Center Hospital, status: RECRUITING, city: Langfang, state: Hebei, country: China, geoPoint lat: 39.50972, lon: 116.69472, locations facility: The First Hospital of Hebei Medical University, status: RECRUITING, city: Shijiazhuang, state: Hebei, country: China, geoPoint lat: 38.04139, lon: 114.47861, locations facility: The Fourth Affiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, state: Heilongjiang, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: The First Hospital of Qiqihar, status: RECRUITING, city: Qiqihar, state: Heilongjiang, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: The Third Affiliated Hospital of Qiqihar Medical College, status: RECRUITING, city: Qiqihar, state: Heilongjiang, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua), status: RECRUITING, city: Luoyang, state: Henan, 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, state: Henan, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: The First Affiliated Hospital of Nanyang Medical College, status: RECRUITING, city: Nanyang, state: Henan, country: China, geoPoint lat: 32.99472, lon: 112.53278, locations facility: Zhumadian Central Hospital, status: RECRUITING, city: Zhumadian, state: Henan, country: China, geoPoint lat: 32.97944, lon: 114.02944, locations facility: Huangshi Central Hospital, status: RECRUITING, city: Huangshi, state: Hubei, country: China, geoPoint lat: 30.24706, lon: 115.04814, locations facility: Jingzhou Central Hospital, status: RECRUITING, city: Jingzhou, state: Hubei, country: China, geoPoint lat: 30.35028, lon: 112.19028, locations facility: The Central Hospital of Wuhan, status: RECRUITING, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The First People's Hospital of Changde City, status: RECRUITING, city: Changde, state: Hunan, country: China, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Hunan Provincial People's Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Yueyang People's Hospital, status: RECRUITING, city: Yueyang, state: Hunan, country: China, geoPoint lat: 29.37455, lon: 113.09481, locations facility: Baotou City Central Hospital, status: RECRUITING, city: Baotou, state: Inner Mongolia, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Inner Mongolia Autonomous Region People's Hospital, status: RECRUITING, city: Hohhot, state: Inner Mongolia, country: China, geoPoint lat: 40.81056, lon: 111.65222, locations facility: The First People's Hospital of Changzhou, status: RECRUITING, city: Changzhou, state: Jiangsu, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: Huai'an First People's Hospital, status: RECRUITING, city: Huai'an, state: Jiangsu, country: China, geoPoint lat: 33.50389, lon: 119.14417, locations facility: The Second People's Hospital of Lianyungang, status: RECRUITING, city: Lianyungang, state: Jiangsu, country: China, geoPoint lat: 34.59845, lon: 119.21556, locations facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nanjing Jiangning Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Sir Run Run Hospital Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Xuzhou Medical University, status: RECRUITING, city: Xuzhou, state: Jiangsu, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Affiliated Hospital of Jiangsu University, status: RECRUITING, city: Zhenjiang, state: Jiangsu, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Pingxiang People's Hospital, status: RECRUITING, city: Pingxiang, state: Jiangxi, country: China, geoPoint lat: 27.61672, lon: 113.85353, locations facility: The Second Norman Bethune Hospital of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Tonghua Central Hospital, status: RECRUITING, city: Tonghua, state: Jilin, country: China, geoPoint lat: 41.71972, lon: 125.92639, locations facility: Panjin Liaohe Oilfield Gem Flower Hospital, status: RECRUITING, city: Panjin, state: Liaoning, country: China, geoPoint lat: 41.121, lon: 122.0739, locations facility: The Sixth People's Hospital of Shenyang, status: RECRUITING, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Qinghai Provincial People's Hospital, status: RECRUITING, city: Xining, state: Qinghai, country: China, geoPoint lat: 36.62554, lon: 101.75739, locations facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, status: RECRUITING, city: Xianyang, state: Shaanxi, country: China, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Jinan Central Hospital, status: RECRUITING, city: Jinan, state: Shandong, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Liaocheng People's Hospital, status: RECRUITING, city: Liaocheng, state: Shandong, country: China, geoPoint lat: 36.45596, lon: 115.97766, locations facility: Shanghai East Hospital of Tongji University, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Third People's Hospital of Datong, status: RECRUITING, city: Datong, state: Shanxi, country: China, geoPoint lat: 40.09361, lon: 113.29139, locations facility: Yuncheng Central Hospital, status: RECRUITING, city: Yuncheng, state: Shanxi, country: China, geoPoint lat: 35.02306, lon: 110.99278, locations facility: People's Hospital of Tianjin, status: RECRUITING, city: Tianjin, state: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First People's Hospital of Kashgar, status: RECRUITING, city: Kashgar, state: Xinjiang, country: China, geoPoint lat: 39.47066, lon: 75.98951, locations facility: The Second Affiliated Hospital of Kunming Medical University, status: RECRUITING, city: Kunming, state: Yunnan, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Huzhou Central Hospital, status: RECRUITING, city: Huzhou, state: Zhejiang, country: China, geoPoint lat: 30.8703, lon: 120.0933, hasResults: False