nctId: NCT06353347 id: HTD1801.PCT106 briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin overallStatus: RECRUITING date: 2023-11-13 date: 2025-03 date: 2025-12 date: 2024-04-09 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 metformin. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 555 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: Baogang Hospital of Inner Mongolia status: RECRUITING city: Baotou country: China lat: 40.65222 lon: 109.82222 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Luhe Hospital Capital Medical University status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Pinggu Hospital status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: The Second Norman Bethune Hospital of Jilin University status: RECRUITING city: Changchun country: China lat: 43.88 lon: 125.32278 facility: The First People's Hospital of Changde City status: RECRUITING city: Changde country: China lat: 29.04638 lon: 111.6783 facility: Hunan Provincial People's Hospital status: RECRUITING city: Changsha country: China lat: 28.19874 lon: 112.97087 facility: The Third Xiangya Hospital of Central South University status: RECRUITING city: Changsha country: China lat: 28.19874 lon: 112.97087 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: The Third People's Hospital of Datong status: RECRUITING city: Datong country: China lat: 40.09361 lon: 113.29139 facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou country: China lat: 23.11667 lon: 113.25 facility: Handan First Hospital status: RECRUITING city: Handan country: China lat: 36.60056 lon: 114.46778 facility: The Fourth Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin country: China lat: 45.75 lon: 126.65 facility: Anhui Provincial Hospital status: RECRUITING city: Hefei country: China lat: 31.86389 lon: 117.28083 facility: The Second Hospital of Anhui Medical University status: RECRUITING city: Hefei country: China lat: 31.86389 lon: 117.28083 facility: Hengshui People's Hospital (Harrison International Peace Hospital) status: RECRUITING city: Hengshui country: China lat: 37.73222 lon: 115.70111 facility: Heze Municipal Hospital status: RECRUITING city: Heze country: China lat: 35.23929 lon: 115.47358 facility: Huai'an First People's Hospital status: RECRUITING city: Huai'an country: China lat: 33.50389 lon: 119.14417 facility: Huangshi Central Hospital status: RECRUITING city: Huangshi country: China lat: 30.24706 lon: 115.04814 facility: Huizhou Municipal Central Hospital status: RECRUITING city: Huizhou country: China lat: 23.11147 lon: 114.41523 facility: Huzhou Central Hospital status: RECRUITING city: Huzhou country: China lat: 30.8703 lon: 120.0933 facility: Jinan Central Hospital status: RECRUITING city: Jinan country: China lat: 36.66833 lon: 116.99722 facility: Jingzhou Central Hospital status: RECRUITING city: Jingzhou country: China lat: 30.35028 lon: 112.19028 facility: Jinzhou Central Hospital status: RECRUITING city: Jinzhou country: China lat: 41.10778 lon: 121.14167 facility: The First People's Hospital of Kashgar status: RECRUITING city: Kashgar country: China lat: 39.47066 lon: 75.98951 facility: Hebei Petro China Center Hospital status: RECRUITING city: Langfang country: China lat: 39.50972 lon: 116.69472 facility: Liaocheng People's Hospital status: RECRUITING city: Liaocheng country: China lat: 36.45596 lon: 115.97766 facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua) status: RECRUITING city: Luoyang 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 country: China lat: 34.68361 lon: 112.45361 facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: Nanjing First Hospital status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: Nanjing Jiangning Hospital status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: Sir Run Run Hospital Nanjing Medical University status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing country: China lat: 32.06167 lon: 118.77778 facility: The First People's Hospital of Nanning status: RECRUITING city: Nanning country: China lat: 22.81667 lon: 108.31667 facility: The First Affiliated Hospital of Nanyang Medical College status: RECRUITING city: Nanyang country: China lat: 32.99472 lon: 112.53278 facility: Panjin Liaohe Oilfield Gem Flower Hospital status: RECRUITING city: Panjin country: China lat: 41.121 lon: 122.0739 facility: The First Hospital of Qiqihar status: RECRUITING city: Qiqihar country: China lat: 47.34088 lon: 123.96045 facility: Shanghai East Hospital of Tongji University status: RECRUITING city: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Shanghai Pudong New Area People's Hospital status: RECRUITING city: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Shengjing Hospital of China Medical University status: RECRUITING city: Shenyang country: China lat: 41.79222 lon: 123.43278 facility: The Sixth People's Hospital of Shenyang status: RECRUITING city: Shenyang country: China lat: 41.79222 lon: 123.43278 facility: Shenzhen People's Hospital status: RECRUITING city: Shenzhen country: China lat: 22.54554 lon: 114.0683 facility: The University of Hong Kong - Shenzhen Hospital status: RECRUITING city: Shenzhen country: China lat: 22.54554 lon: 114.0683 facility: Taihe Hospital status: RECRUITING city: Shiyan country: China lat: 32.6475 lon: 110.77806 facility: Siping City Central People's Hospital status: RECRUITING city: Siping country: China lat: 43.16143 lon: 124.37785 facility: The First Affiliated Hospital of Suzhou University status: RECRUITING city: Suzhou country: China lat: 31.30408 lon: 120.59538 facility: People's Hospital of Tianjin status: RECRUITING city: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: Tonghua Central Hospital status: RECRUITING city: Tonghua country: China lat: 41.71972 lon: 125.92639 facility: The Central Hospital of Wuhan status: RECRUITING city: Wuhan country: China lat: 30.58333 lon: 114.26667 facility: Yijishan Hospital of Wannan Medical College status: RECRUITING city: Wuhu country: China lat: 31.33728 lon: 118.37351 facility: The First People's Hospital of Xiangtan City status: RECRUITING city: Xiangtan country: China lat: 27.85 lon: 112.9 facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou country: China lat: 34.18045 lon: 117.15707 facility: Yanan University Affiliated Hospital status: RECRUITING city: Yanan country: China facility: Yueyang People's Hospital status: RECRUITING city: Yueyang country: China lat: 29.37455 lon: 113.09481 facility: Yuncheng Central Hospital status: RECRUITING city: Yuncheng country: China lat: 35.02306 lon: 110.99278 facility: The Second Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou country: China lat: 34.75778 lon: 113.64861 facility: Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang country: China lat: 32.21086 lon: 119.45508 facility: Zhumadian Central Hospital status: RECRUITING city: Zhumadian country: China lat: 32.97944 lon: 114.02944 facility: Zhuzhou Central Hospital status: RECRUITING city: Zhuzhou country: China lat: 27.83333 lon: 113.15 facility: Zibo Central Hospital status: RECRUITING city: Zibo country: China lat: 36.79056 lon: 118.06333 facility: The First People's Hospital of Zunyi status: RECRUITING city: Zunyi country: China lat: 27.68667 lon: 106.90722 hasResults: False