Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:28 AM
Study NCT ID:
NCT07332156
Status:
COMPLETED
Last Update Posted:
2026-01-14
First Post:
2025-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Cancer Risk in Type 2 Diabetes With COPD: SGLT2 Inhibitors vs. Sulfonylureas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D054873', 'term': 'Dipeptidyl-Peptidase IV Inhibitors'}], 'ancestors': [{'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': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21692}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2025-12-28', 'studyFirstSubmitQcDate': '2025-12-28', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung cancer', 'timeFrame': 'From index date + 30 days to the end of follow-up', 'description': 'ICD-10 code (C33 or C34) and code for special purposes (V193)'}], 'secondaryOutcomes': [{'measure': 'COPD exacerbation', 'timeFrame': 'From index date + 30 days to the end of follow-up', 'description': 'COPD (J43 or J44, not J43.0) and antibiotics or steroids prescription and (emergency department or admission)'}, {'measure': 'Any cancer', 'timeFrame': 'From index date + 30 days to the end of follow-up', 'description': "ICD-10 code ('C' code) and code for special purposes (V193)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SGLT2 inhibitor', 'Sulfonylurea', 'T2DM with COPD', 'Lung cancer'], 'conditions': ['Type 2 Diabetes', 'COPD (Chronic Obstructive Pulmonary Disease)', 'Lung Cancer (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn if a specific diabetes medicine can lower the risk of lung cancer in people with type 2 diabetes and chronic obstructive pulmonary disease (COPD).\n\nThe main question it aims to answer is:\n\n\\- Does taking medicines called SGLT2 inhibitors lower the chance of getting lung cancer compared to medicines called sulfonylureas?\n\nResearchers will compare the medical records of people taking SGLT2 inhibitors to those taking sulfonylureas to see if the SGLT2 group has fewer cases of lung cancer.\n\nParticipants will not need to visit a doctor or take new medicines for this study. Researchers will use information from existing medical records to answer the research question.', 'detailedDescription': 'Study Design: This is a comparative effectiveness research study utilizing large-scale, population-based Real-World Data (RWD). By analyzing longitudinal data from existing medical records, researchers will emulate a target trial to minimize bias and provide robust estimates of the treatment effect.\n\nStatistical Analysis Plan: The study employs a rigorous analytic framework consisting of a primary analysis and multiple sensitivity analyses to ensure the validity of the findings:\n\nPrimary Analysis: A comparison of SGLT2 inhibitors versus sulfonylureas using an Intention-To-Treat (ITT) framework, with follow-up censored upon treatment switching to estimate the effect of the initial treatment choice.\n\nSensitivity Analysis 1 (Active Comparator): A comparison of DPP-4 inhibitors versus SGLT2 inhibitors using the same ITT framework (censoring on switching) to assess the consistency of the results against an alternative second-line antidiabetic class.\n\nSensitivity Analysis 2 (As-Treated): A comparison of SGLT2 inhibitors versus sulfonylureas using an As-Treated approach, defining continuous use with a permissible gap (grace period) of 60 days between prescriptions to account for adherence patterns.\n\nSignificance and Impact Current guidelines for diabetes management prioritize cardiovascular and renal protection. This study aims to expand the clinical evidence base by:\n\n* Providing actionable Real-World Evidence (RWE) on the long-term cancer-related outcomes of diabetes medications.\n* Evaluating whether the choice of antidiabetic agents can serve as a strategy for lung cancer prevention in high-risk groups (COPD-T2DM).\n* Contributing to the development of comprehensive treatment guidelines that consider cancer prevention alongside metabolic, cardiac, and renal health.\n\nAbbreviation:\n\nCOPD, Chronic Obstructive Pulmonary Disease; DPP-4, Dipeptidyl Peptidase-4; ICD-10, International Classification of Diseases, 10th Revision; ICS, Inhaled Corticosteroids; ITT, Intention-To-Treat; LABA, Long-Acting Beta-2 Agonists; LAMA, Long-Acting Muscarinic Antagonists; RWD, Real-World Data; RWE, Real-World Evidence; SABA, Short-Acting Beta-2 Agonists; SAMA, Short-Acting Muscarinic Antagonists; SGLT2, Sodium-Glucose Cotransporter-2; SU, Sulfonylurea; T2DM, Type 2 Diabetes Mellitus;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included adults aged ≥40 years with a prior history of COPD (screened from 2009) and newly diagnosed type 2 diabetes who initiated treatment with either sulfonylureas or SGLT2 inhibitors between January 1, 2014, and December 31, 2023. Type 2 diabetes was defined as having two or more diagnosis records within one year using ICD-10 codes E10-E14. COPD was defined by the presence of ICD-10 codes J43 or J44 (excluding J43.0) concurrent with the prescription of COPD medications at least twice within a year; these medications included long-acting muscarinic antagonists (LAMA), long-acting beta-2 agonists (LABA), ICS plus LABA, short-acting muscarinic antagonists (SAMA), short-acting beta-2 agonists (SABA), SAMA plus SABA, methylxanthines, and systemic beta agonists.\n\nIn the sensitivity analysis, we are planning to substitute sulfonylurea to DPP4 inhibitors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥40 years with prior COPD (from 2009) and newly diagnosed diabetes who initiated SU or SGLT2i between January 1, 2014 and December 31, 2023\n\nExclusion Criteria:\n\n* Pre-existing\n* ESRD\n* Cancer\n* Concurrent prescribing of the study drugs at the index date\n* Exposure to the drugs of interest during the year preceding the index date\n* Death or cancer incidence within a month\n\nIn the sensitivity analysis, we are planning to substitute sulfonylurea to DPP4 inhibitors.'}, 'identificationModule': {'nctId': 'NCT07332156', 'briefTitle': 'Lung Cancer Risk in Type 2 Diabetes With COPD: SGLT2 Inhibitors vs. Sulfonylureas', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Lung Cancer Incidence in Patients With Type 2 Diabetes and COPD: A Real-World Retrospective Cohort Study Comparing SGLT2 Inhibitors and Sulfonylureas', 'orgStudyIdInfo': {'id': 'SU vs. SGLT2 in T2DM with COPD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group (main)', 'description': 'Users of SGLT2 inhibitors (for ITT analysis)', 'interventionNames': ['Drug: SGLT2 inhibitor']}, {'label': 'Active control group (main)', 'description': 'Users of sulfonylureas for ITT analysis', 'interventionNames': ['Drug: Sulfonylureas (SU)']}, {'label': 'Treatment group (S1)', 'description': 'Users of SGLT2 inhibitors (for ITT analysis)', 'interventionNames': ['Drug: SGLT2 inhibitor']}, {'label': 'Active control group (S1)', 'description': 'Users of DPP4 inhibitors (for ITT analysis)', 'interventionNames': ['Drug: Sulfonylureas (SU)']}, {'label': 'Treatment group (S2)', 'description': 'Users of SGLT2 inhibitors (for as-treated analysis)', 'interventionNames': ['Drug: SGLT2 inhibitor']}, {'label': 'Active control group (S2)', 'description': 'Users of sulfonylureas (for as-treated analysis)', 'interventionNames': ['Drug: DPP4 inhibitors']}], 'interventions': [{'name': 'SGLT2 inhibitor', 'type': 'DRUG', 'description': 'Any new prescription of SGLT2 inhibitors after new onset of T2DM', 'armGroupLabels': ['Treatment group (S1)', 'Treatment group (S2)', 'Treatment group (main)']}, {'name': 'Sulfonylureas (SU)', 'type': 'DRUG', 'description': 'Any new prescription of sulfonylureas after new onset of T2DM', 'armGroupLabels': ['Active control group (S1)', 'Active control group (main)']}, {'name': 'DPP4 inhibitors', 'type': 'DRUG', 'description': 'Any new prescription of DPP4 inhibitors after new onset of T2DM', 'armGroupLabels': ['Active control group (S2)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Danbee Kang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}