Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 10:48 PM
Study NCT ID:
NCT05677334
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2022-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, randomized, controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose', 'timeFrame': 'Monitoring 5-14 days', 'description': 'Compare the TIR of the two treatment groups'}], 'secondaryOutcomes': [{'measure': 'Time taken for TIR >70%', 'timeFrame': '5-14 days after treatment', 'description': 'Compare the time required for TIR \\>70% of the two groups'}, {'measure': 'Mean Amplitude of Glycemic Excursions (MAGE)', 'timeFrame': '5-14 days after treatment', 'description': 'Compare the mage of the two treatment groups'}, {'measure': 'time below range (TBR)', 'timeFrame': '5-14 days after treatment', 'description': 'Compare the TBR of the two treatment groups'}, {'measure': 'total insulin dosage', 'timeFrame': '5-14 days after treatment', 'description': 'Compare the total insulin dosage of the two treatment groups'}, {'measure': 'time above range (TAR)', 'timeFrame': '5-14 days after treatment', 'description': 'Compare the TAR of the two treatment groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continuous subcutaneous insulin infusion', 'sglt2i', 'Continuous Glucose Monitoring', 'Type 2 diabetes'], 'conditions': ['Type2diabetes']}, 'referencesModule': {'references': [{'pmid': '39395826', 'type': 'DERIVED', 'citation': 'Wu Y, Huang Z, Qin Y. Efficacy and safety of henagliflozin combined with continuous subcutaneous insulin infusion in the treatment of Chinese inpatients with type 2 diabetes mellitus based on a continuous glucose monitoring system: protocol of a multicentre, open-label, inpatient, randomised, controlled trial. BMJ Open. 2024 Oct 11;14(10):e084834. doi: 10.1136/bmjopen-2024-084834.'}]}, 'descriptionModule': {'briefSummary': 'The Multi-center, randomized, controlled clinical trial investigate the efficacy and safety of Henagliflozin combined with continuous subcutaneous insulin infusion in newly diagnosed type 2 diabetes', 'detailedDescription': 'The therapeutic mechanisms of Sglt2i and continuous subcutaneous insulin infusion (CSII) are complementary. We hypothesized that for newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia, combination treatment with Henagliflozin and CSII could achieve glycaemic control in a shorter time, shorten the duration of hospitalization and reduce the total insulin dosage. We also hope to investigate the safety of sglt2i in combination with CSII in T2DM based on continuous glucose monitoring system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed as type 2 diabetes mellitus, diagnosis time ≤ 2 years\n2. Age between 20 and 70 years\n3. Continuous use of any hypoglycemic drug ≤ 7 days within 6 months\n4. 9% ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/L\n5. Body mass index (BMI) of between 20 and 32 kg/m2\n6. Be able to understand the contents and methods of this study and sign the informed consent form voluntarily\n\nExclusion Criteria:\n\n1. Diabetic ketosis or ketoacidosis, diabetic hypertonic state, diabetic lactic acidosis and other acute diabetic complications or serious chronic diabetic complications\n2. Urinary tract infection or/and genital infection with clinical significance, or repeated urinary tract infection or/and genital infection history\n3. Serious trauma or acute infection occurred within 4 weeks that may affect blood glucose control\n4. People with negligent compensatory heart failure (NYHA grade III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, serious arrhythmia, cardiac surgery or vascular reconstruction within 6 months\n5. Serious blood system disease (such as aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (such as malaria, hemolytic anemia)\n6. Severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery)\n7. Uncontrolled hyperthyroidism\n8. Those who have mental or nervous system diseases and are unwilling to communicate or cannot fully understand and cooperate\n9. Pregnant or lactating women\n10. ALT\\>3.0x ULN and/or AST\\>3.0x ULN and/or Tbil\\>2.0x ULN Blood ketone body\\>ULN eGFR\\<30ml/min/1.73 m2 Blood creatine kinase\\>3.0x ULN'}, 'identificationModule': {'nctId': 'NCT05677334', 'briefTitle': 'Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Guangxi Medical University'}, 'officialTitle': 'Study on the Efficacy and Safety of Henagliflozin Combined with Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring System', 'orgStudyIdInfo': {'id': '2022-K148-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Henagliflozin+ Continuous Subcutaneous Insulin Infusion', 'description': 'Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion', 'interventionNames': ['Drug: Henagliflozin', 'Device: Continuous Subcutaneous Insulin Infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Subcutaneous Insulin Infusion', 'description': 'Continuous Subcutaneous Insulin Infusion therapy alone', 'interventionNames': ['Device: Continuous Subcutaneous Insulin Infusion']}], 'interventions': [{'name': 'Henagliflozin', 'type': 'DRUG', 'otherNames': ['Continuous Subcutaneous Insulin Infusion'], 'description': 'Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion', 'armGroupLabels': ['Henagliflozin+ Continuous Subcutaneous Insulin Infusion']}, {'name': 'Continuous Subcutaneous Insulin Infusion', 'type': 'DEVICE', 'description': 'Continuous Subcutaneous Insulin Infusion therapy alone', 'armGroupLabels': ['Continuous Subcutaneous Insulin Infusion', 'Henagliflozin+ Continuous Subcutaneous Insulin Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables.figures, and appendices) will be shared.', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.\n\nInvestigators could contact the corresponding author. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}