Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT06099067
Status:
COMPLETED
Last Update Posted:
2024-08-30
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068896', 'term': 'Canagliflozin'}, {'id': 'D054873', 'term': 'Dipeptidyl-Peptidase IV Inhibitors'}, {'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'C502994', 'term': 'saxagliptin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239990}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-point MACE', 'timeFrame': 'Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days]', 'description': '3-point MACE: Relative hazard of composite outcome of Stroke, MI, and Mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical Trial', 'Emulation', 'Epidemiology', 'Type 2 Diabetes', 'Regulatory', 'Real World Evidence', 'Real World Data'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/NCT03936010', 'label': 'CANVAS'}, {'url': 'https://clinicaltrials.gov/ct2/show/NCT03936049', 'label': 'LEADER'}, {'url': 'https://clinicaltrials.gov/ct2/show/NCT03936023', 'label': 'SAVOR-TIMI'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1843R00345&attachmentIdentifier=6f9731f7-7f0a-432d-bfeb-b5aaa30e1f99&fileName=Redacted_CSR_Synopsis_D1843R00345.pdf&versionIdentifier=', 'label': 'The Redacted CSR synopsis'}]}, 'descriptionModule': {'briefSummary': "Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses.", 'detailedDescription': "RCT-duplicate (RCT-D) is an initiative led by the Brigham and Women's Hospital and Harvard Medical School, that selected 30 clinical trials as part of an empirical experiment where these trials would be emulated using RWD. AstraZeneca will replicate three emulations CANVAS, LEADER, and SAVOR TIMI from among the 30 plus clinical trials analyzed in RCT-D. These clinical trials assess type 2 diabetes mellitus drugs. The replications will be conducted on the Instant Health Data PANALGOS (IHD) platform to assess these studies in two claims databases Optum and IBM Watson Market Scan. The aim is to recreate these three emulations to investigate the reproducibility of the emulations, increase transparency and better understand the process of trial emulations; and where possible, contribute with potential improvements to the RCT-D framework."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetes mellitus (T2DM) adult patients enrolled in the two claims databases and are eligible to be included according to the inclusion and exclusion criteria of each of the three investigated clinical trial studies: CANVAS, LEADER and SAVOR-TIMI.\n\nAll subjects meeting the inclusion and exclusion criteria will be assessed. Remaining sample size will be dependent on the number of matched subjects in each cohort using the two data sources combined.', 'healthyVolunteers': False, 'eligibilityCriteria': 'The Eligibility Criteria for CANVAS, LEADER and SAVOR-TIMI are replicated\n\nPlease see the Criteria for each under:\n\n* CANVAS: https://clinicaltrials.gov/ct2/show/NCT03936010\n* LEADER: https://clinicaltrials.gov/ct2/show/NCT03936049\n* SAVOR-TIMI: https://clinicaltrials.gov/ct2/show/NCT03936023'}, 'identificationModule': {'nctId': 'NCT06099067', 'acronym': 'HARRP', 'briefTitle': 'Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Harmonizing RCT-Duplicate Emulations: A Real World Replication Program Analyzing Three Clinical Trials, CANVAS, LEADER, and SAVOR TIMI in Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'D1843R00345'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CANVAS Canagliflozin', 'description': 'CANVAS expousre Group', 'interventionNames': ['Drug: Canagliflozin']}, {'label': 'CANVAS DPP4i', 'description': 'CANVAS reference Group', 'interventionNames': ['Drug: DPP4 inhibitor']}, {'label': 'LEADER Liraglutide', 'description': 'LEADER exposure Group', 'interventionNames': ['Drug: Liraglutide']}, {'label': 'LEADER DPP4i', 'description': 'LEADER reference Group', 'interventionNames': ['Drug: DPP4 inhibitor']}, {'label': 'SAVOR-TIMI Saxagliptin', 'description': 'SAVOR-TIMI exposure Group', 'interventionNames': ['Drug: Saxagliptin']}, {'label': 'SAVOR-TIMI 2nd generation Sulfonylurea', 'description': 'SAVOR-TIMI reference Group', 'interventionNames': ['Drug: 2nd generation Sulfonylurea']}], 'interventions': [{'name': 'Canagliflozin', 'type': 'DRUG', 'description': 'Canagliflozin dispensing claim is used as the exposure drug in CANVAS replication', 'armGroupLabels': ['CANVAS Canagliflozin']}, {'name': 'DPP4 inhibitor', 'type': 'DRUG', 'description': 'DPP4 inhibitor dispensing claim is used as the reference drug in CANVAS and LEADER replications', 'armGroupLabels': ['CANVAS DPP4i', 'LEADER DPP4i']}, {'name': 'Liraglutide', 'type': 'DRUG', 'description': 'Liraglutide dispensing claim is used as the Exposure drug in LEADER replication', 'armGroupLabels': ['LEADER Liraglutide']}, {'name': 'Saxagliptin', 'type': 'DRUG', 'description': 'Saxagliptin dispensing claim is used as the Exposure drug in SAVOR-TIMI replication', 'armGroupLabels': ['SAVOR-TIMI Saxagliptin']}, {'name': '2nd generation Sulfonylurea', 'type': 'DRUG', 'description': '2nd generation Sulfonylurea dispensing claim is used as the Exposure drug in SAVOR-TIMI replication', 'armGroupLabels': ['SAVOR-TIMI 2nd generation Sulfonylurea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43183', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'from 05 December 2022', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'Protocol and SAP details along with programming code to be supplied upon request via mail.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}