Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT05333835
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2022-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'HR17031 injection compared with Ins068 injection and SHR20004 injection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 455}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-23', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in HbA1c at Week 26', 'timeFrame': 'at Week 26'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26', 'timeFrame': 'at Week 26'}, {'measure': 'Mean Change From Baseline in Body Weight at Week 26', 'timeFrame': 'at Week 26'}, {'measure': 'Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26', 'timeFrame': 'at Week 26'}, {'measure': 'Mean Actual Daily Insulin Dose at Week 26', 'timeFrame': 'at Week 26'}, {'measure': 'Number of Hypoglycaemic Episodes at Week 26', 'timeFrame': 'at Week 26'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18-70 age years, both inclusive;\n2. BMI is 20.0 to 40.0 kg/m2, both inclusive;\n3. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;\n4. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;\n5. At screening:\n\n1\\) Treatment with metformin alone on a stable dose (≥1500 mg or at the maximum tolerated dose \\[MTD, ≥1000 mg\\]) for ≥3 months, or 2) Treatment with metformin at the above dose level combined with a second OAD (AGI, SU, TZD, glinides, DPP-4i or SGLT2i) on a stable dose (≥half of the max approved dose according to local label, or at the MTD) for ≥3 months.\n\nExclusion Criteria:\n\n1. Use of systemic glucocorticoids within 3 months prior to the screening;\n2. Use of weight loss drugs within 3 months prior to the screening.\n3. Treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes);\n4. Laboratory findings at the screening visit:\n\n * Amylase and/or lipase \\>3 x upper limit of normal (ULN);\n * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 x ULN;\n * Moderate (3b) or severe renal failure or renal insufficiency or according to local contraindications for metformin;\n * Urinary albumin creatinine ratio (UACR) ≥300 mg/g;\n * Total bilirubin \\>2.0 x ULN;\n * Calcitonin ≥50 ng/L;\n5. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)；\n6. Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 6 months prior to screening and/or planned coronary, carotid or peripheral artery revascularization procedures;\n7. Severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);\n8. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;\n9. History of pancreatitis (acute or chronic);\n10. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures；'}, 'identificationModule': {'nctId': 'NCT05333835', 'briefTitle': 'A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A 26-week, Randomized, Open-label, 3-arm Parallel, Treat-to-target Study Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin With or Without One Other Oral Anti-diabetic Drug', 'orgStudyIdInfo': {'id': 'HR17031-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HR17031 injection', 'interventionNames': ['Drug: HR17031 injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'INS068 injection', 'interventionNames': ['Drug: INS068 injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SHR20004 injection', 'interventionNames': ['Drug: SHR20004 injection']}], 'interventions': [{'name': 'HR17031 injection', 'type': 'DRUG', 'description': 'HR17031 injection', 'armGroupLabels': ['HR17031 injection']}, {'name': 'INS068 injection', 'type': 'DRUG', 'description': 'INS068 injection', 'armGroupLabels': ['INS068 injection']}, {'name': 'SHR20004 injection', 'type': 'DRUG', 'description': 'SHR20004 injection', 'armGroupLabels': ['SHR20004 injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking university People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}