Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-01 @ 5:50 PM
Study NCT ID:
NCT05073692
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Type 2 Diabetes Pharmacotherapy Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D005913', 'term': 'Glipizide'}, {'id': 'C520853', 'term': 'alogliptin'}], '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'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Romain.S.Neugebauer@kp.org', 'phone': '510-891-3234', 'title': 'Romain Neugebauer', 'organization': 'Kaiser Permanente Division of Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2.5 years.', 'description': 'Death other than cardiovascular death which is included in the study primary outcome MACE. We are reporting these deaths as all-cause mortality.\n\nNo Other Adverse Events or Serious Adverse Events were defined as part of this observational study and its protocol.\n\nSerious and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'SU Initiators', 'description': 'Initiators of Sulfonylurea between 01/01/2014 and 12/31/2021; sample size N=212,042.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 212042, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 4867, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DPP4 Initiators', 'description': 'Initiators of DPP4 between 01/01/2014 and 12/31/2021; sample size N=5,862.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 5862, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 235, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SGLT2i Initiators', 'description': 'Initiators of SGLT2i between 01/01/2014 and 12/31/2021; sample size N=14,858.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 14858, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 117, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'GLP-1RA Initiators', 'description': 'Initiators of GLP-1RA between 01/01/2014 and 12/31/2021; sample size N=9,219.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 9219, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 109, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of 3-point Major Adverse Cardiovascular Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212,042', 'groupId': 'OG000'}, {'value': '5,862', 'groupId': 'OG001'}, {'value': '14,858', 'groupId': 'OG002'}, {'value': '9,219', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SU Initiators', 'description': 'Initiators of Sulfonylurea between 01/01/2014 and 12/31/2021; sample size N=212,042.'}, {'id': 'OG001', 'title': 'DPP4 Initiators', 'description': 'Initiators of DPP4 between 01/01/2014 and 12/31/2021; sample size N=5,862.'}, {'id': 'OG002', 'title': 'SGLT2i Initiators', 'description': 'Initiators of SGLT2i between 01/01/2014 and 12/31/2021; sample size N=14,858.'}, {'id': 'OG003', 'title': 'GLP-1RA Initiators', 'description': 'Initiators of GLP-1RA between 01/01/2014 and 12/31/2021; sample size N=9,219.'}], 'classes': [{'categories': [{'measurements': [{'value': '11,348', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '424', 'groupId': 'OG002'}, {'value': '296', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2.5 years', 'description': '3-point MACE is defined as a single outcome measure, which is a composite measure of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular disease death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SU Initiators', 'description': 'Initiators of Sulfonylurea between 01/01/2014 and 12/31/2021; sample size N=212,042.'}, {'id': 'FG001', 'title': 'DPP4 Initiators', 'description': 'Initiators of DPP4 between 01/01/2014 and 12/31/2021; sample size N=5,862.'}, {'id': 'FG002', 'title': 'SGLT2i Initiators', 'description': 'Initiators of SGLT2i between 01/01/2014 and 12/31/2021; sample size N=14,858.'}, {'id': 'FG003', 'title': 'GLP-1RA Initiators', 'description': 'Initiators of GLP-1RA between 01/01/2014 and 12/31/2021; sample size N=9,219.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212042'}, {'groupId': 'FG001', 'numSubjects': '5862'}, {'groupId': 'FG002', 'numSubjects': '14858'}, {'groupId': 'FG003', 'numSubjects': '9219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169348'}, {'groupId': 'FG001', 'numSubjects': '4402'}, {'groupId': 'FG002', 'numSubjects': '13681'}, {'groupId': 'FG003', 'numSubjects': '7863'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42694'}, {'groupId': 'FG001', 'numSubjects': '1460'}, {'groupId': 'FG002', 'numSubjects': '1177'}, {'groupId': 'FG003', 'numSubjects': '1356'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212,042', 'groupId': 'BG000'}, {'value': '5,862', 'groupId': 'BG001'}, {'value': '14,858', 'groupId': 'BG002'}, {'value': '9,219', 'groupId': 'BG003'}, {'value': '241981', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'SU Initiators', 'description': 'Initiators of Sulfonylurea between 01/01/2014 and 12/31/2021; sample size N=212,042.'}, {'id': 'BG001', 'title': 'DPP4 Initiators', 'description': 'Initiators of DPP4 between 01/01/2014 and 12/31/2021; sample size N=5,862.'}, {'id': 'BG002', 'title': 'SGLT2i Initiators', 'description': 'Initiators of SGLT2i between 01/01/2014 and 12/31/2021; sample size N=14,858.'}, {'id': 'BG003', 'title': 'GLP-1RA Initiators', 'description': 'Initiators of GLP-1RA between 01/01/2014 and 12/31/2021; sample size N=9,219.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.91', 'spread': '12.91', 'groupId': 'BG000'}, {'value': '61.69', 'spread': '12.88', 'groupId': 'BG001'}, {'value': '60.51', 'spread': '11.95', 'groupId': 'BG002'}, {'value': '55.95', 'spread': '12.34', 'groupId': 'BG003'}, {'value': '57.21', 'spread': '12.88', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95,560', 'groupId': 'BG000'}, {'value': '3,123', 'groupId': 'BG001'}, {'value': '6,537', 'groupId': 'BG002'}, {'value': '5,319', 'groupId': 'BG003'}, {'value': '110539', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '116,482', 'groupId': 'BG000'}, {'value': '2,739', 'groupId': 'BG001'}, {'value': '8,321', 'groupId': 'BG002'}, {'value': '3,900', 'groupId': 'BG003'}, {'value': '131442', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '78,965', 'groupId': 'BG000'}, {'value': '1,098', 'groupId': 'BG001'}, {'value': '3,501', 'groupId': 'BG002'}, {'value': '1,943', 'groupId': 'BG003'}, {'value': '85507', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '133,077', 'groupId': 'BG000'}, {'value': '4,764', 'groupId': 'BG001'}, {'value': '11,357', 'groupId': 'BG002'}, {'value': '7,276', 'groupId': 'BG003'}, {'value': '156474', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1,505', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '1671', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '33,756', 'groupId': 'BG000'}, {'value': '735', 'groupId': 'BG001'}, {'value': '2,690', 'groupId': 'BG002'}, {'value': '731', 'groupId': 'BG003'}, {'value': '37912', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3,303', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}, {'value': '3878', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20,977', 'groupId': 'BG000'}, {'value': '669', 'groupId': 'BG001'}, {'value': '1,483', 'groupId': 'BG002'}, {'value': '1,343', 'groupId': 'BG003'}, {'value': '24472', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '103,428', 'groupId': 'BG000'}, {'value': '3,689', 'groupId': 'BG001'}, {'value': '7,666', 'groupId': 'BG002'}, {'value': '5,609', 'groupId': 'BG003'}, {'value': '120392', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '5,740', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}, {'value': '7111', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '43,333', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '1,894', 'groupId': 'BG002'}, {'value': '822', 'groupId': 'BG003'}, {'value': '46545', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-10', 'size': 142909, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-10T20:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241981}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2021-09-14', 'resultsFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-11', 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of 3-point Major Adverse Cardiovascular Events (MACE)', 'timeFrame': '2.5 years', 'description': '3-point MACE is defined as a single outcome measure, which is a composite measure of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular disease death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Cardiovascular Diseases', 'Medication', 'Treatment'], 'conditions': ['Type 2 Diabetes Mellitus', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '38488777', 'type': 'BACKGROUND', 'citation': 'Thomas TW, Hooker SA, Schmittdiel JA. Principles for Stakeholder Engagement in Observational Health Research. JAMA Health Forum. 2024 Mar 1;5(3):e240114. doi: 10.1001/jamahealthforum.2024.0114.'}, {'pmid': '38745886', 'type': 'RESULT', 'citation': "Rodriguez LA, Finertie H, Neugebauer RS, Gosiker B, Thomas TW, Karter AJ, Gilliam LK, Oshiro C, An J, Simonson G, Cassidy-Bushrow AE, Dombrowski S, Nolan M, O'Connor PJ, Schmittdiel JA. Race and ethnicity and pharmacy dispensing of SGLT2 inhibitors and GLP-1 receptor agonists in type 2 diabetes. Lancet Reg Health Am. 2024 May 7;34:100759. doi: 10.1016/j.lana.2024.100759. eCollection 2024 Jun."}, {'pmid': '40734551', 'type': 'RESULT', 'citation': "Thapa B, Schmittdiel JA, Arterburn D, Neugebauer R, Dyer W, O'Connor PJ, An J, Cassidy-Bushrow AE, Gilliam LK, Hooker SA, Nolan MB, Oshiro CES, Thomas T, Simonson G, Dombrowski SK, Rodriguez LA. Clinical and Demographic Characteristics Associated With Diabetes Remission in Six Integrated Health Care Systems: A Retrospective Cohort Study. Diabetes Care. 2025 Oct 1;48(10):1737-1743. doi: 10.2337/dc25-0530."}, {'pmid': '41091469', 'type': 'RESULT', 'citation': "Neugebauer R, An J, Dombrowski SK, Oshiro C, Cassidy-Bushrow A, Gilliam L, Simonson G, Karter AJ, Bergenstal R, Finertie H, Yassin MM, Knowlton G, Lin SR, Dyer W, Pimentel N, Izadian K, Schmittdiel J, Thomas TW, Hooker SA, Nolan MB, Wright E, Aurora L, Rodriguez LA, Kaur J, Adams AS, van der Laan MJ, O'Connor PJ. Glucose-Lowering Medication Classes and Cardiovascular Outcomes in Patients With Type 2 Diabetes. JAMA Netw Open. 2025 Oct 1;8(10):e2536100. doi: 10.1001/jamanetworkopen.2025.36100."}]}, 'descriptionModule': {'briefSummary': 'This study is designed to help patients with type 2 diabetes and their clinicians: (a) identify which glucose lowering medications have the most favorable effects on heart health and other patient-important outcomes, (b) inform the timing of medication initiation, and (c) identify whether medication benefits apply equally to all adults with type 2 diabetes, or may be different based on age, sex, race/ethnicity, baseline heart health status, baseline renal function, or other factors.', 'detailedDescription': 'The study will conduct head-to-head comparisons of type 2 diabetes mellitus (T2DM) treatment strategies using observational data from real-world clinical settings to assess cardiovascular disease (CVD) outcomes and other patient-centered outcomes in T2DM patients with moderate baseline CVD risk who are treated with each of these four classes of glucose-lowering medications known as SGLT2, GLP-1RA, DPP4, and SU. To mitigate bias concerns related to confounding and informative loss to follow-up, analyses will be based on modern causal inference methods combined with machine learning that emulate intention-to-treat (ITT) and per-protocol (PP) analyses of pragmatic randomized trials with active comparators to provide the most robust and precise estimates of relative and absolute effects we would expect in usual care settings.\n\nSpecific Aims and Hypotheses:\n\nAim 1. Compare the effect off SGLT21, GLP-1RA, DPP4, and SU on each study outcome in adults with T2DM when each type of medication is (a) initiated as second-line therapy after metformin, and (b) initiated as first-, second-, or third-line therapy, or after any history of glucose-lowering therapy independent of prior metformin use.\n\nAim 2. Compare the effect on each study outcome of earlier versus later initiation of SGLT2i, GLP-1RA, DPP4, SU as first-, or second-, or third-line therapy, or after any history of glucose-lowering therapy triggered by various changes in A1C, or CVD risk, or other patient characteristics.\n\nAim 3. Assess in each of the prior analyses whether the treatment effects on study outcomes vary across categories of baseline CVD risk and CVD event history, renal function, congestive heart failure status, age, sex and race/ethnicity, or other patient characteristics.\n\nGlucose-lowering medications will be compared at both the class and agent level. The key outcomes that will be considered are MACE 3-point, Myocardial Infarction, Stroke, Heart Failure, Hospitalization, Coronary or Carotid Artery Stent or Bypass Procedure, CVD Mortality, Overall Mortality. Additional patient-centered outcomes will be specified based on insights from stakeholder members of the research team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from six large care delivery systems with integrated administrative and EHR clinical data sources (Geisinger in Pennsylvania, Henry Ford Health System in Michigan, HealthPartners Institute in Minnesota and Wisconsin, and Kaiser Permanente of Northern California, Southern California, and Hawaii) who were new users of glucose-lowering medications between 01/01/2014 and 12/31/2021.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Dispensing of either of the set of drugs being compared\n* No prior dispensing of nor contraindication for any of the drugs compared\n* Evidence of Type 2 Diabetes Mellitus diagnosis\n* Age 18 or older\n* Not currently pregnant\n* No evidence of dementia or short-term life expectancy from prior cancer diagnoses\n* History of ≥2 years of continuous health plan membership\n* ≥1 A1c test in the past 18 months'}, 'identificationModule': {'nctId': 'NCT05073692', 'acronym': 'ON TARGET DM', 'briefTitle': 'Comparison of Type 2 Diabetes Pharmacotherapy Regimens', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Comparison of Type 2 Diabetes Pharmacotherapy Regimens Using Targeted Learning', 'orgStudyIdInfo': {'id': '739857'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SU', 'type': 'DRUG', 'description': 'Exposure to the class of drugs known as Sulfonylureas (SU)'}, {'name': 'DPP4', 'type': 'DRUG', 'description': 'Exposure to the class of drugs known as Dipeptidyl peptidase-4 inhibitors (DPP4)'}, {'name': 'SGLT2i', 'type': 'DRUG', 'description': 'Exposure to the class of drugs known as Sodium-glucose cotransporter-2 inhibitors (SGLT2i)'}, {'name': 'GLP-1RA', 'type': 'DRUG', 'description': 'Exposure to the class of drugs known as Glucagon-like peptide-1 receptor agonists (GLP-1RA)'}, {'name': 'SGLT2i or GLP-1RA', 'type': 'DRUG', 'description': 'Exposure to either SGLT2i or GLP-1RA'}, {'name': 'Linagliptin (DPP4)', 'type': 'DRUG', 'description': 'Exposure to agent Linagliptin (DPP4)'}, {'name': 'Exenatide (GLP-1RA)', 'type': 'DRUG', 'description': 'Exposure to agent Exenatide (GLP1-RA)'}, {'name': 'Liraglutide (GLP-1RA)', 'type': 'DRUG', 'description': 'Exposure to agent Liraglutide (GLP-1RA)'}, {'name': 'Empagliflozin (SGLT2i)', 'type': 'DRUG', 'description': 'Exposure to agent Empagliflozin (SGLT2i)'}, {'name': 'Glimepiride (SU)', 'type': 'DRUG', 'description': 'Exposure to agent Glimepiride (SU)'}, {'name': 'Glipizide (SU)', 'type': 'DRUG', 'description': 'Exposure to Glimepiride (SU)'}, {'name': 'Glimepiride (SU) or Glipizide (SU)', 'type': 'DRUG', 'description': 'Exposure to agent Glimepiride (SU) or Glipizide (SU)'}, {'name': 'SU or DPP4 (excluding saxagliptin and alogliptin)', 'type': 'DRUG', 'description': 'Exposure to either SU or DPP4 excluding Saxagliptin and Alogliptin'}, {'name': 'Exenatide (GLP-1RA) or Liraglutide (GLP-1RA)', 'type': 'DRUG', 'description': 'Exposure to either Exenatide (GLP-1RA) or Liraglutide (GLP-1RA)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Romain S. Neugebauer', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Permanente Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55425', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Institute', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '17821', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'overallOfficials': [{'name': 'Romain S. Neugebauer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}, {'name': "Patrick J O'Connor, MD, MA, MPH", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Geisinger Clinic', 'class': 'OTHER'}, {'name': 'Henry Ford Health System', 'class': 'OTHER'}, {'name': 'HealthPartners Institute', 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}