Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05345327
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 994}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of decline in eGFR', 'timeFrame': '24 months', 'description': 'Change in estimated glomerular filtration rate (eGFR) from study baseline to 24 months, in ml/min/1.73m2/year'}], 'secondaryOutcomes': [{'measure': 'Urine albumin creatinine ratio', 'timeFrame': '24 months', 'description': 'Effects of dapagliflozin vs metformin, from baseline to 24 months, on urine albumin creatinine ratio (mg/g)'}, {'measure': 'Serum creatinine', 'timeFrame': '24 months', 'description': 'Effects of dapagliflozin vs metformin, from baseline to 24 months, on serum creatinine (umol/L)'}, {'measure': 'HbA1C', 'timeFrame': '24 months', 'description': 'Effects of dapagliflozin vs metformin, from baseline to 24 months, on HbA1C (%)'}, {'measure': 'Fasting blood glucose', 'timeFrame': '24 months', 'description': 'Effects of dapagliflozin vs metformin, from baseline to 24 months, on fasting blood glucose (mmol/L)'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '24 months', 'description': 'Effects of dapagliflozin vs metformin, from baseline to 24 months, on systolic and diastolic blood pressure (mmHg)'}, {'measure': 'Body weight', 'timeFrame': '24 months', 'description': 'Effects of dapagliflozin vs metformin, from baseline to 24 months, on body weight (kg)'}, {'measure': 'Quality of life measured by EQ-5D-5L', 'timeFrame': '24 months', 'description': 'Effects of dapagliflozin vs metformin, from baseline to 24 months, on quality of life measured by European Quality of Life 5-Dimensional Assessment, 5-Level version'}, {'measure': 'Anxiety and depression symptoms measured by HADS', 'timeFrame': '24 months', 'description': 'Effects of dapagliflozin vs. metformin, from baseline to 24 months, on anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Renal decline', 'Metformin', 'Sodium Glucose Co-Transporter 2 inhibitor'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes.', 'detailedDescription': 'This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of T2D;\n* Aged ≥18 years;\n* Body mass index \\> 18.5 kg/m2;\n* Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin;\n* eGFR ≥45 ml/min/1,73m2; and\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or\n* There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor; or\n* They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) or clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); or\n* Pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT05345327', 'acronym': 'START', 'briefTitle': 'SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'The George Institute'}, 'officialTitle': 'SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'P01148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin 10mg', 'description': '1x over-encapsulated Dapagliflozin 10mg tablet and 2x Metformin placebo tablets, taken orally once daily for 2 years', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin XR 2000mg', 'description': '2x Metformin XR 1000mg tablets and 1x over-encapsulated Dapagliflozin placebo, taken orally once daily for 2 years', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'SGLT2 inhibitor', 'armGroupLabels': ['Dapagliflozin 10mg']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin', 'armGroupLabels': ['Metformin XR 2000mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2042', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Emma Zhang', 'role': 'CONTACT', 'email': 'ezhang1@georgeinstitute.org.au', 'phone': '+61 2 8052 4337'}, {'name': 'Sarah Stanton', 'role': 'CONTACT', 'email': 'sstanton@georgeinstitute.org.au'}, {'name': 'Bruce Neal', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Clare Arnott', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The George Institute for Global Health', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4000', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Emma Zhang', 'role': 'CONTACT', 'email': 'ezhang1@georgeinstitute.org.au', 'phone': '+61 2 8052 4337'}, {'name': 'Sarah Stanton', 'role': 'CONTACT', 'email': 'sstanton@georgeinstitute.org.au'}, {'name': 'Bruce Neal', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Clare Arnott', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The George Institute for Global Health', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Simone Spark', 'role': 'CONTACT', 'email': 'simone.spark@monash.edu'}, {'name': 'Zachary Flanagan', 'role': 'CONTACT', 'email': 'Zachary.Flanagan@monash.edu'}, {'name': 'Sophia Zoungas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Monash University', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '80000', 'city': 'Galle', 'state': 'Southern Province', 'status': 'NOT_YET_RECRUITING', 'country': 'Sri Lanka', 'contacts': [{'name': 'Muditha Weerakkody', 'role': 'CONTACT', 'email': 'mudithaweerakkody@gmail.com', 'phone': '+94 714 050 524'}, {'name': 'Muditha Weerakkody', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Hospital - Galle', 'geoPoint': {'lat': 6.0461, 'lon': 80.2103}}, {'zip': '00700', 'city': 'Colombo', 'status': 'RECRUITING', 'country': 'Sri Lanka', 'contacts': [{'name': 'Manilka Sumanatilleke', 'role': 'CONTACT', 'email': 'manilkasumana@gmail.com', 'phone': '+94 777 440 208'}, {'name': 'Manilka Sumanatilleke', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Hospital of Sri Lanka 1', 'geoPoint': {'lat': 6.93548, 'lon': 79.84868}}, {'zip': '00700', 'city': 'Colombo', 'status': 'NOT_YET_RECRUITING', 'country': 'Sri Lanka', 'contacts': [{'name': 'Uditha Bulugahapitiya', 'role': 'CONTACT', 'email': 'udithakaush@gmail.com', 'phone': '+94 777 440 208'}, {'name': 'Uditha Bulugahapitiya', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Hospital of Sri Lanka 2', 'geoPoint': {'lat': 6.93548, 'lon': 79.84868}}, {'zip': '40000', 'city': 'Jaffna', 'status': 'RECRUITING', 'country': 'Sri Lanka', 'contacts': [{'name': 'Mahalingam Ararinthan', 'role': 'CONTACT', 'email': 'ara.jho@gmail.com', 'phone': '0772619589'}, {'name': 'Mahalingam Aravinthan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jaffna Teaching Hospital', 'geoPoint': {'lat': 9.66845, 'lon': 80.00742}}, {'zip': '20000', 'city': 'Kandy', 'status': 'RECRUITING', 'country': 'Sri Lanka', 'contacts': [{'name': 'Charles Antonypillai', 'role': 'CONTACT', 'email': 'cantonypillai@gmail.com', 'phone': '+94773417639'}, {'name': 'Charles Antonypillai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kandy National Hospital', 'geoPoint': {'lat': 7.2906, 'lon': 80.6336}}], 'centralContacts': [{'name': 'Emma Zhang', 'role': 'CONTACT', 'email': 'ezhang1@georgeinstitute.org.au', 'phone': '+61 2 8052 4337'}, {'name': 'Sarah Stanton', 'role': 'CONTACT', 'email': 'sstanton@georgeinstitute.org.au'}], 'overallOfficials': [{'name': 'Bruce Neal', 'role': 'STUDY_CHAIR', 'affiliation': 'The George Institute for Global Health (Sydney, Australia)'}, {'name': 'Clare Arnott', 'role': 'STUDY_CHAIR', 'affiliation': 'The George Institute for Global Health (Sydney, Australia)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of New South Wales', 'class': 'OTHER'}, {'name': 'Monash University', 'class': 'OTHER'}, {'name': 'University of Sydney', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}