Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-22 @ 5:22 AM
Study NCT ID:
NCT02741960
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2016-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Metformin on Reducing Lupus Flares
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-04-15', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numbers of participants who remained at risk of flares at each visit', 'timeFrame': 'one year', 'description': 'the effect of metformin on reducing disease flares'}], 'secondaryOutcomes': [{'measure': 'changes in prednisone dose from baseline at each visit', 'timeFrame': 'one year', 'description': 'the influence of metformin on corticosteroid sparing effect'}, {'measure': 'changes in BMI from baseline at each visit', 'timeFrame': 'one year', 'description': 'the influence of metformin on BMI'}, {'measure': 'number of participants with treatment-related adverse events', 'timeFrame': 'one year', 'description': 'the safety of metformin'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metformin', 'systemic lupus erythematosus'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '26245802', 'type': 'BACKGROUND', 'citation': 'Wang H, Li T, Chen S, Gu Y, Ye S. Neutrophil Extracellular Trap Mitochondrial DNA and Its Autoantibody in Systemic Lupus Erythematosus and a Proof-of-Concept Trial of Metformin. Arthritis Rheumatol. 2015 Dec;67(12):3190-200. doi: 10.1002/art.39296.'}, {'pmid': '38268156', 'type': 'DERIVED', 'citation': 'Sun F, Wang HJ, Liu Z, Geng S, Wang HT, Wang X, Li T, Morel L, Wan W, Lu L, Teng X, Ye S. Safety and efficacy of metformin in systemic lupus erythematosus: a multicentre, randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. 2020 Apr;2(4):e210-e216. doi: 10.1016/S2665-9913(20)30004-7. Epub 2020 Feb 24.'}, {'pmid': '33093216', 'type': 'DERIVED', 'citation': 'Sun F, Geng S, Wang H, Wang H, Liu Z, Wang X, Li T, Wan W, Lu L, Teng X, Morel L, Ye S. Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials. Lupus Sci Med. 2020 Oct;7(1):e000429. doi: 10.1136/lupus-2020-000429.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomised, double-blind placebo controlled trial on the efficacy and safety of add-on metformin to conventional immunosuppressants in systemic lupus erythematosus (SLE).\n\nThe purpose of this study is to evaluate: 1) the effect of metformin on reducing disease flares; 2) the influence of metformin on corticosteroid sparing effect; 3) the influence of metformin on body mass index (BMI); 4) the safety of metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willingness of the subject to participate in the study, proven by signing the informed consent;\n* Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;\n* The course of SLE longer than1 year; and there is a clear record of disease flares in the past 1 year with prednisone more than 20mg/day;\n* Patients with mild/moderate disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A or no more than one B;\n* A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/ mycophenolate mofetil/ methotrexate/ ciclosporin/ leflunomide/ thalidomide) for at least 30 days.\n\nExclusion Criteria:\n\n* Patients who are unwilling to sign the inform consent;\n* Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \\> 2 times upper normal limits; creatinine clearance rate \\< 60ml/min;\n* Patients who used cyclophosphamide 6-months before screening; used biological agents 12-months before screening;\n* Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;\n* Patients who diagnosed of diabetes mellitus;\n* Pregnancy or lactation."}, 'identificationModule': {'nctId': 'NCT02741960', 'acronym': 'Met Lupus', 'briefTitle': 'The Effect of Metformin on Reducing Lupus Flares', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'SHDC12015902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'metformin', 'description': "Eligible patients for clinical trial were randomized in a 1:1 ratio to metformin/placebo add-on. Subjects randomized to metformin will receive a target dose of 500 mg three times daily. Investigators were allowed to adjust the dose according to the patients' tolerance.", 'interventionNames': ['Drug: metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': "Eligible patients for clinical trial were randomized in a 1:1 ratio to metformin/placebo add-on. Subjects randomized to placebo will receive a target dose of 500 mg three times daily. Investigators were allowed to adjust the dose according to the patients' tolerance.", 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'metformin', 'type': 'DRUG', 'otherNames': ['Metformin Hydrochloride Tablets'], 'description': '500 mg metformin three times daily', 'armGroupLabels': ['metformin']}, {'name': 'placebo', 'type': 'DRUG', 'description': '500 mg placebo three times daily', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shuang Ye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Director, Dept. Rheumatology, Renji Hospital South Campus', 'investigatorFullName': 'Shuang Ye', 'investigatorAffiliation': 'RenJi Hospital'}}}}