Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-12 @ 5:41 PM
Study NCT ID:
NCT02366351
Status:
UNKNOWN
Last Update Posted:
2015-02-19
First Post:
2015-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611095', 'term': 'henagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-18', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-02-18', 'lastUpdatePostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Mean Change in HbA1c Levels', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'The number of volunteers with adverse events as a measure of safety and tolerability', 'timeFrame': 'Baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean Change in Fasting Plasma Glucose', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%', 'timeFrame': 'Baseline to Week 12'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824 over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have a diagnosis of type 2 diabetes mellitus;\n* Hemoglobin A1c levels \\>=7.5% and \\<=10.5%;\n* Body mass index (BMI) 25 to 45 kg/m2;\n* Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.\n\nExclusion Criteria:\n\n* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);\n* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);\n* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;\n* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;\n* Past or current history of malignant tumor;\n* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;\n* Pregnant women, lactating mothers, or women of childbearing potential;\n* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator)."}, 'identificationModule': {'nctId': 'NCT02366351', 'briefTitle': 'The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Clinical Trial to Evaluate the Pharmacokinetics/Pharmacodynamics, Efficacy and Safety of SHR3824 as Monotherapy in Chinese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control', 'orgStudyIdInfo': {'id': 'SHR3824-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR3824 Placebo', 'description': 'once daily, 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SHR3824 5 mg', 'description': 'once daily, 12 weeks', 'interventionNames': ['Drug: SHR3824']}, {'type': 'EXPERIMENTAL', 'label': 'SHR3824 10 mg', 'description': 'once daily, 12 weeks', 'interventionNames': ['Drug: SHR3824']}, {'type': 'EXPERIMENTAL', 'label': 'SHR3824 20 mg', 'description': 'once daily, 12 weeks', 'interventionNames': ['Drug: SHR3824']}], 'interventions': [{'name': 'SHR3824', 'type': 'DRUG', 'description': 'Once daily, 12 weeks', 'armGroupLabels': ['SHR3824 10 mg', 'SHR3824 20 mg', 'SHR3824 5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily, 12 weeks', 'armGroupLabels': ['SHR3824 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juming Lu, PhD', 'role': 'CONTACT', 'phone': '010-66937166'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}