Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-15 @ 2:40 AM
Study NCT ID:
NCT02768220
Status:
WITHDRAWN
Last Update Posted:
2018-02-15
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000069476', 'term': 'Linagliptin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in AGE levels', 'timeFrame': '30 days', 'description': 'Measurement of serum and urinary AGE levels'}], 'secondaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': '30 days', 'description': 'measurement of BP'}, {'measure': 'Change in weight', 'timeFrame': '30 days', 'description': 'measurement of weight'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SGLT-2 Inhibitors', 'Advanced Glycation End Products', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration.', 'detailedDescription': 'Single-center open-label multiple dose randomized two period cross-over study.\n\nThe North-Shore Long Island Jewish Institutional Review Board will be used to approve our study protocol.\n\nAll patients will give written informed consent and comply with the Helsinki agreement and good clinical practices guidelines.\n\nTreatment Plan:\n\nEligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. All pre-existing diabetic medications will continue unchanged.\n\nFasting blood carboxymethyl lysine (CML), methylglyoxal (MG), vascular cell adhesion molecule (VCAM), tumor necrosis factor (TNF) alpha, 8-isoprostane, and routine chemistries and urinary CML, MG, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days.\n\nAGE levels will be measured by Elisa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2DM\n* Age ≥ 18\n* glomerular filtration rate ≥ 30 ml/min/1.73 m2 body-surface area\n* A1C ≥ 7% any higher limit\n* SLGT-2 inhibitor naïve\n* On stable doses of current medications for at least 3 months.\n\nExclusion Criteria:\n\n* Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 2 x upper limit of normal during screening or run-in phase\n* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells\n* Contraindications to background therapy according to the local label\n* Any uncontrolled endocrine disorder except type 2 diabetes\n* Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who were nursing, pregnant, or of child-bearing potential and were not practicing an acceptable method of birth control, or did not plan to continue using this method throughout the study, or did not agree to submit to periodic pregnancy testing during the trial\n\n o Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method, vasectomy of partner\n* Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake\n* Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up'}, 'identificationModule': {'nctId': 'NCT02768220', 'briefTitle': 'The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products', 'orgStudyIdInfo': {'id': 'SGLT2-AGE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Linagliptin', 'description': 'Eligible patients were randomized to receive linagliptin 5mg daily for 30 days.', 'interventionNames': ['Drug: empagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Empagliflozin', 'description': 'Eligible patients were randomized empagliflozin 25mg daily for 30 days.', 'interventionNames': ['Drug: linagliptin']}], 'interventions': [{'name': 'empagliflozin', 'type': 'DRUG', 'otherNames': ['Jardiance'], 'description': 'Test to see how 30 days of jardiance changes serum and urinary advanced glycation end product levels', 'armGroupLabels': ['Linagliptin']}, {'name': 'linagliptin', 'type': 'DRUG', 'otherNames': ['tradjenta'], 'description': 'Test to see how 30 days of tradjenta changes serum and urinary advanced glycation end product levels', 'armGroupLabels': ['Empagliflozin']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Caroline Messer', 'investigatorAffiliation': 'Northwell Health'}}}}