Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
Study NCT ID:
NCT06703268
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2024-11-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on Switching From Daily DPP-4 Inhibitor to HSK7653 in Type 2 Diabetes 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in range', 'timeFrame': '24 weeks', 'description': 'The change in time in range (TIR) of continuous glucose monitoring (CGM) relative to the baseline after 24 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '24 weeks', 'description': 'Change from baseline in HbA1c after 24 weeks'}, {'measure': 'Fasting glucose', 'timeFrame': '24 weeks', 'description': 'Change from baseline in fasting glucose after 24 weeks'}, {'measure': 'Mean glucose', 'timeFrame': '24 weeks', 'description': 'Change from baseline in mean glucose after 24 weeks'}, {'measure': 'Treatment-emergent adverse events.', 'timeFrame': '24 weeks', 'description': 'The incidence of treatment-emergent adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HSK7653', 'DPP-4i'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of HSK7653 tablets following the substitution of daily DPP-4 inhibitor (DPP-4i) over a 24-week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 and Age ≤75 years\n* T2DM patients,\n* During the 12 weeks before screening, on the basis of diet control and exercise therapy, patients only regularly received daily DPP-4 inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin and retagliptin , etc.) or combined with metformin (with a metformin dose of ≥ 1500 mg/day, or the maximum tolerated dose \\< 1500 mg/day but ≥ 1000 mg/day);\n* HbA1c ≥6.5% and HbA1c \\<8.0%\n* FPG \\<10.0 mmol/L\n* BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)\n\nExclusion Criteria:\n\n* Non-type 2 diabetes: Type 1 diabetes, gestational diabetes or other special types of diabetes.\n* The presence of any of the following medical histories or conditions at the time of screening:\n* History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the recent 6 months;\n* History of ≥2 episodes of severe hypoglycemia within the last 6 months;\n* History of malignant tumors within the recent 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ), or currently being evaluated for potential malignant tumors.\n* Presence of severe mental disorders or language barriers, unwilling or unable to fully understand and cooperate.\n* History of drug abuse within the past 5 years\n* Previous history or clinical evidence of acute or chronic pancreatitis.\n* Using other drugs that may affect blood glucose metabolism within 12 weeks prior to screening, including systemic glucocorticoids (except for inhaled or topical ones), growth hormones, etc.\n* Any laboratory test index meeting the following criteria:\n* Hemoglobin \\< 110 g/L (for males) or \\< 100 g/L (for females).\n* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\> 3 times the upper limit of the normal value.\n* Total bilirubin (TBIL) \\> 2 times the upper limit of the normal value.\n* Fasting triglyceride (TG) \\> 5.7 mmol/L.\n* Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula \\< 45 mL/min/1.73m².\n* Known to be allergic to the investigational products or related excipients.'}, 'identificationModule': {'nctId': 'NCT06703268', 'briefTitle': 'A Study on Switching From Daily DPP-4 Inhibitor to HSK7653 in Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Open-label, Controlled Study on Evaluating the Efficacy and Safety of Switching From Daily DPP-4 Inhibitors to HSK7653 Tablets in Patients With Type 2 Diabetes Mellitus in China', 'orgStudyIdInfo': {'id': 'HSK7653-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSK7653', 'description': 'HSK7653 10mg Q2W', 'interventionNames': ['Drug: HSK7653 10 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daily DPP-4 inhibitor', 'description': 'Daily DPP-4 inhibitor', 'interventionNames': ['Drug: Daily DPP-4 inhibitor']}], 'interventions': [{'name': 'HSK7653 10 mg', 'type': 'DRUG', 'description': 'HSK7653 10 mg Q2W', 'armGroupLabels': ['HSK7653']}, {'name': 'Daily DPP-4 inhibitor', 'type': 'DRUG', 'description': 'Daily DPP-4 inhibitor', 'armGroupLabels': ['Daily DPP-4 inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Chu Hsien-I Memorial Hospital, Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haisco Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}