Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-01-02 @ 11:44 AM
Study NCT ID:
NCT03848793
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2019-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '16 weeks treatment', 'description': 'Estimated mean change from baseline in HbA1c at week 16. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': '16 weeks treatment', 'description': 'Estimated mean change from baseline in FPG at week 16.'}, {'measure': 'Change in Body Weight', 'timeFrame': '16 weeks treatment', 'description': 'Estimated mean change from baseline in Body Weigh at week 16.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes diagnosed for more than 3 months\n* HbA1c between 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l\n* Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)\n\nExclusion Criteria：\n\n* History or family history of drug allergy\n* Subjects treated with any other anti-diabetes drug within 8 weeks before screening\n* Participation in any other clinical trial of an investigational medicinal product within 3 months before screening\n* Smoker or alcohol abuse\n* Currently use or plan to use systemic corticosteroid\n* History of recurrent severe hypoglycemia\n* Type 1 diabetes or secondary diabetes mellitus\n* Uncontrolled active or untreated hypertension\n* History of pancreatitis (acute or chronic)\n* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)\n* Serious unconscious hypoglycemia history\n* Within the past 6 months before screening any of the following: coronary artery revascularization, patients presently classified as being in New York Heart Association (NYHA) Class III or IV, myocardial infarction, stroke or unstable angina and/or persistent and clinically significant arrhythmias\n* Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control\n* Subject was not used for the study as determined by the Investigator'}, 'identificationModule': {'nctId': 'NCT03848793', 'briefTitle': 'A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase 2, Multiple Centers, Double-blind, Placebo-Controlled, Randomised Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.', 'orgStudyIdInfo': {'id': 'HS-20004-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HS-20004 or placebo treatment (Low dose)', 'description': 'HS-20004 or placebo SC once daily (Low dose)', 'interventionNames': ['Drug: HS-20004']}, {'type': 'OTHER', 'label': 'HS-20004 or placebo treatment (median dose 1)', 'description': 'HS-20004 or placebo SC once daily (median dose 1)', 'interventionNames': ['Drug: HS-20004']}, {'type': 'OTHER', 'label': 'HS-20004 or placebo treatment (median dose 2)', 'description': 'HS-20004 or placebo SC once daily (median dose 2)', 'interventionNames': ['Drug: HS-20004']}, {'type': 'OTHER', 'label': 'HS-20004 or placebo treatment (high dose)', 'description': 'HS-20004 or placebo SC once daily (high dose)', 'interventionNames': ['Drug: HS-20004']}], 'interventions': [{'name': 'HS-20004', 'type': 'DRUG', 'otherNames': ['Noiiglutide Injection'], 'description': 'treatment', 'armGroupLabels': ['HS-20004 or placebo treatment (Low dose)', 'HS-20004 or placebo treatment (high dose)', 'HS-20004 or placebo treatment (median dose 1)', 'HS-20004 or placebo treatment (median dose 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}