nctId: NCT06350890 id: HTD1801.PCT105 briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-11-05 date: 2025-03 date: 2025-09 date: 2024-04-08 date: 2024-04-18 name: HighTide Biopharma Pty Ltd class: INDUSTRY 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. conditions: T2DM (Type 2 Diabetes Mellitus) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 405 type: ESTIMATED name: HTD1801 name: Placebo measure: Primary Endpoint: Mean Change in HbA1c measure: Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose measure: DB Phase: Mean Change in 2-Hour Postprandial Glucose measure: DB Phase: Proportion of patients achieving HbA1c <7.0% measure: DB Phase: Proportion of patients achieving HbA1c <6.5% measure: DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR) measure: DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C) measure: Open Label Extension (OLE) Phase: Mean Change in HbA1c measure: OLE Phase: Mean change in 2-Hour Postprandial Glucose measure: OLE Phase: Proportion of patients achieving HbA1c <7.0% measure: OLE Phase: Proportion of patients achieving HbA1c <6.5% measure: OLE Phase: Mean Change in Insulin Sensitivity (HOMA-IR) measure: OLE Phase: Mean Change in LDL-C sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuancheng People's Hospital status: RECRUITING city: Xuancheng state: Anhui country: China lat: 25.40949 lon: 116.3841 facility: Beijing Pinggu Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Fuwai Hospital, CAMS & PUMC status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Huizhou Municipal Central Hospital status: RECRUITING city: Huizhou state: Guangdong country: China lat: 23.11147 lon: 114.41523 facility: Shenzhen People's Hospital status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: Liuzhou People's Hospital status: RECRUITING city: Liuzhou state: Guangxi country: China facility: Cangzhou Central Hospital status: RECRUITING city: Cangzhou state: Hebei country: China lat: 38.31667 lon: 116.86667 facility: Handan First Hospital status: RECRUITING city: Handan state: Hebei country: China lat: 36.60056 lon: 114.46778 facility: Hengshui People's Hospital (Harrison International Peace Hospital) status: RECRUITING city: Hengshui state: Hebei country: China lat: 37.73222 lon: 115.70111 facility: Hebei Petro China Center Hospital status: RECRUITING city: Langfang state: Hebei country: China lat: 39.50972 lon: 116.69472 facility: The First Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China lat: 38.04139 lon: 114.47861 facility: The Fourth Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: The Third Affiliated Hospital of Qiqihar Medical College status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua) status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan) status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Nanyang Medical College status: RECRUITING city: Nanyang state: Henan country: China lat: 32.99472 lon: 112.53278 facility: Zhumadian Central Hospital status: RECRUITING city: Zhumadian state: Henan country: China lat: 32.97944 lon: 114.02944 facility: Huangshi Central Hospital status: RECRUITING city: Huangshi state: Hubei country: China lat: 30.24706 lon: 115.04814 facility: Jingzhou Central Hospital status: RECRUITING city: Jingzhou state: Hubei country: China lat: 30.35028 lon: 112.19028 facility: The Central Hospital of Wuhan status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: The First People's Hospital of Changde City status: RECRUITING city: Changde state: Hunan country: China lat: 29.04638 lon: 111.6783 facility: Hunan Provincial People's Hospital status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: Yueyang People's Hospital status: RECRUITING city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: Baotou City Central Hospital status: RECRUITING city: Baotou state: Inner Mongolia country: China lat: 40.65222 lon: 109.82222 facility: Inner Mongolia Autonomous Region People's Hospital status: RECRUITING city: Hohhot state: Inner Mongolia country: China lat: 40.81056 lon: 111.65222 facility: The First People's Hospital of Changzhou status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: Huai'an First People's Hospital status: RECRUITING city: Huai'an state: Jiangsu country: China lat: 33.50389 lon: 119.14417 facility: The Second People's Hospital of Lianyungang status: RECRUITING city: Lianyungang state: Jiangsu country: China lat: 34.59845 lon: 119.21556 facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Nanjing Jiangning Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Sir Run Run Hospital Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou state: Jiangsu country: China lat: 34.18045 lon: 117.15707 facility: Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: Pingxiang People's Hospital status: RECRUITING city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: The Second Norman Bethune Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: Tonghua Central Hospital status: RECRUITING city: Tonghua state: Jilin country: China lat: 41.71972 lon: 125.92639 facility: Panjin Liaohe Oilfield Gem Flower Hospital status: RECRUITING city: Panjin state: Liaoning country: China lat: 41.121 lon: 122.0739 facility: The Sixth People's Hospital of Shenyang status: RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: Qinghai Provincial People's Hospital status: RECRUITING city: Xining state: Qinghai country: China lat: 36.62554 lon: 101.75739 facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine status: RECRUITING city: Xianyang state: Shaanxi country: China lat: 34.33778 lon: 108.70261 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: Liaocheng People's Hospital status: RECRUITING city: Liaocheng state: Shandong country: China lat: 36.45596 lon: 115.97766 facility: Shanghai East Hospital of Tongji University status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: The Third People's Hospital of Datong status: RECRUITING city: Datong state: Shanxi country: China lat: 40.09361 lon: 113.29139 facility: Yuncheng Central Hospital status: RECRUITING city: Yuncheng state: Shanxi country: China lat: 35.02306 lon: 110.99278 facility: People's Hospital of Tianjin status: RECRUITING city: Tianjin state: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: The First People's Hospital of Kashgar status: RECRUITING city: Kashgar state: Xinjiang country: China lat: 39.47066 lon: 75.98951 facility: The Second Affiliated Hospital of Kunming Medical University status: RECRUITING city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 facility: Huzhou Central Hospital status: RECRUITING city: Huzhou state: Zhejiang country: China lat: 30.8703 lon: 120.0933 hasResults: False