Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-01 @ 5:51 AM
Study NCT ID:
NCT04965506
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
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': 'C000719829', 'term': 'mazdutide'}, {'id': 'C555680', 'term': 'dulaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-24', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in HbA1c from baseline to 20 weeks', 'timeFrame': 'Baseline,20 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving HbA1c Target of <7.0%', 'timeFrame': 'Baseline,20 weeks'}, {'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': 'Baseline,25 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999)\n2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening.\n3. Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening).\n4. Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter\n\nExclusion Criteria:\n\n1. Type 1 diabetes, special types of diabetes, or gestational diabetes.\n2. Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening.\n3. History of severe hypoglycemic episodes within 6 months prior to screening.\n4. Have had any of the following within the last 6 months prior to screening: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (TIA), cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure.'}, 'identificationModule': {'nctId': 'NCT04965506', 'briefTitle': 'A Study of IBI362 in Chinese Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Randomized Phase II Study to Evaluate the Efficacy and Safety of IBI362 Versus Placebo and Dulaglutide in Chinese Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'CIBI362A201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBI362 low dose', 'description': 'Participants receive low dose IBI362 by subcutaneous (SC) injection once a week.', 'interventionNames': ['Drug: IBI362']}, {'type': 'EXPERIMENTAL', 'label': 'IBI362 moderate dose', 'description': 'Participants receive medium dose IBI362 by subcutaneous (SC) injection once a week.', 'interventionNames': ['Drug: IBI362']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dulaglutide', 'description': 'Participants receive Dulaglutide 1.5mg by subcutaneous (SC) injection once a week.', 'interventionNames': ['Other: Dulaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'IBI362 high dose', 'description': 'Participants receive high dose IBI362 by subcutaneous (SC) injection once a week.', 'interventionNames': ['Drug: IBI362']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Participants receive placebo by subcutaneous (SC) injection once a week.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'IBI362', 'type': 'DRUG', 'description': 'IBI362 administered subcutaneously (SC) once a week.', 'armGroupLabels': ['IBI362 high dose', 'IBI362 low dose', 'IBI362 moderate dose']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo administered subcutaneously (SC) once a week.', 'armGroupLabels': ['placebo']}, {'name': 'Dulaglutide', 'type': 'OTHER', 'description': 'Dulaglutide administered subcutaneously (SC) once a week.', 'armGroupLabels': ['Dulaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}