Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:42 AM
Study NCT ID:
NCT06168812
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2023-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005913', 'term': 'Glipizide'}], 'ancestors': [{'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide', 'timeFrame': '48 hours after glipizide initiation', 'description': 'The mean value measured over a 48-h period before initiation of glipizide will be compared with the mean value measured over a 48-h period after glipizide initiation for participants in Cohort 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Pancreatic Carcinoma', 'Pancreatic Ductal Adenocarcinoma', 'Pancreatic Cancer Metastatic', 'Metastatic Pancreatic Cancer', 'Metastatic Pancreatic Ductal Adenocarcinoma', 'Glipizide', 'Memorial Sloan Kettering Cancer Center', '23-318'], 'conditions': ['Pancreatic Cancer', 'Pancreatic Carcinoma', 'Pancreatic Ductal Adenocarcinoma', 'Pancreatic Cancer Metastatic', 'Metastatic Pancreatic Cancer', 'Metastatic Pancreatic Ductal Adenocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out how effective and safe glipizide is for lowering blood sugar in people with pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCohort 1\n\n* Age ≥18 years\n* Biopsy-proven PDAC\n* Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)\n* Willing and able to comply with the requirements of the protocol\n* Willing to use their bluetooth-enabled wifi or cellular mobile device\n* Hemoglobin A1c (HbA1c) \\> 7%, or fructosamine \\> 287 mg/dL, or random glucose \\> 180 mg/dL, or strong clinical suspicion that patient has hyperglycemia, making it reasonable to expect their mean daily glucose is ≥154 mg/dL\n* Eastern Cooperative Oncology Group performance status ≤2\n* BMI \\<30 kg/m2\n\nCohort 2a\n\n* Age ≥18 years\n* Biopsy-proven PDAC\n* Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic pancreatic cancer)\n* Clinical diagnosis of diabetes mellitus\n* Active care at MSK (defined as at least 1 physician or APP encounter every 3 months) for PDAC during the period from which data were recorded in the electronic medical record (in this retrospective study patients need not be under active care at the time the research is conducted)\n* At least 1 electronic prescription for a sulfonylurea (glipizide, glimepiride, or glyburide) or metformin\n* Three-month baseline period before metformin or sulfonylurea initiation in which the participant does not receive either drug class or insulin\n* Body weight recorded within 3 months before start of metformin or a sulfonylurea\n\nCohort 2b\n\n* Age ≥18 years\n* Biopsy-proven PDAC\n* Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)\n* Active care at MSK (defined as at least 1 physician or APP encounter every 3 months) for PDAC during the period of data collection\n* Apparent current use based on chart review of metformin (but not sulfonylurea); sulfonylurea (but not metformin); or neither drug\n\nExclusion Criteria:\n\nCohort 1\n\n* Use during the past month of any antidiabetic medication other than metformin at home (sporadic use \\[fewer than 1 of 7 days during the past month\\] is permitted)\n* Changes in metformin dose in the past month\n* History of sulfonylurea intolerance or allergy\n* History of severe hypoglycemia (hypoglycemia requiring emergency medical assistance, emergency room or urgent care visit, or hospital admission)\n* AST or ALT \\>3 x upper limit of normal\n* Glomerular filtration rate \\<30 mL/min/1.73m2\n* Daily chronic use of any dose of corticosteroids (as distinct from intermittent exposure to steroids as part of cyclic chemotherapy)\n* Inability to wear CGM\n\nCohort 2a\n\n* Greater than trace ascites documented on imaging or physical exam\n\nCohort 2b\n\n* Greater than trace ascites documented on imaging or physical exam'}, 'identificationModule': {'nctId': 'NCT06168812', 'briefTitle': 'A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Sulfonylurea Safety and Effectiveness (SUSS) for Patients With Hyperglycemia and Pancreatic Ductal Adenocarcinoma: A Pragmatic Clinical Trial and Accompanying Retrospective Revie', 'orgStudyIdInfo': {'id': '23-318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Participants in this cohort will receive glipizide for up to 4 months and participate in continuous glucose monitoring for as long as they are receiving the drug.', 'interventionNames': ['Drug: Glipizide']}, {'type': 'NO_INTERVENTION', 'label': 'Cohort 2a', 'description': "Participants in this cohort will include people who have received various types of treatment for their hyperglycemia and pancreatic cancer. People's medical records will be reviewed to compare the effects of glipizide with the effects of other standard medications used to treat hyperglycemia."}, {'type': 'NO_INTERVENTION', 'label': 'Cohort 2b', 'description': 'Participants in this cohort will complete a questionnaire about their use of hyperglycemia medications. Participants from Cohort 2a will take part in this group.'}], 'interventions': [{'name': 'Glipizide', 'type': 'DRUG', 'otherNames': ['sulfonylurea glipizide', 'Glucotrol'], 'description': 'The therapeutic intervention in this study involves the sulfonylurea glipizide in ER formulation.', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Flory, MD', 'role': 'CONTACT', 'phone': '646-608-2684'}], 'facility': 'Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Flory, MD', 'role': 'CONTACT', 'phone': '646-608-2684'}], 'facility': 'Memorial Sloan Kettering Monmouth (Limited protocol activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Flory, MD', 'role': 'CONTACT', 'phone': '646-608-2684'}], 'facility': 'Memorial Sloan Kettering Bergen (Limited Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Flory, MD', 'role': 'CONTACT', 'phone': '646-608-2684'}], 'facility': 'Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Flory, MD', 'role': 'CONTACT', 'phone': '646-608-2684'}], 'facility': 'Memorial Sloan Kettering Westchester (Limited Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Flory, MD', 'role': 'CONTACT', 'phone': '646-608-2684'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Flory, MD', 'role': 'CONTACT', 'phone': '646-608-2684'}], 'facility': 'Memorial Sloan Kettering Nassau (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'James Flory, MD', 'role': 'CONTACT', 'email': 'floryj@mskcc.org', 'phone': '646-608-2684'}, {'name': "Eileen O'Reilly, MD", 'role': 'CONTACT', 'email': 'oreillye@MSKCC.ORG', 'phone': '646-888-4182'}], 'overallOfficials': [{'name': 'James Flory, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'url': 'https://www.mskcc.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.', 'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.', 'accessCriteria': 'The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Berkeley', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}