A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer
Sulfonylurea Safety and Effectiveness (SUSS) for Patients With Hyperglycemia and Pancreatic Ductal Adenocarcinoma: A Pragmatic Clinical Trial and Accompanying Retrospective Revie
1 other identifier
interventional
29
1 country
7
Brief Summary
The purpose of this study is to find out how effective and safe glipizide is for lowering blood sugar in people with pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pancreatic-cancer
Started Dec 2023
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2023
CompletedStudy Start
First participant enrolled
December 5, 2023
CompletedFirst Posted
Study publicly available on registry
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 5, 2026
January 15, 2026
January 1, 2026
3 years
December 5, 2023
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide
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
48 hours after glipizide initiation
Study Arms (3)
Cohort 1
EXPERIMENTALParticipants 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.
Cohort 2a
NO INTERVENTIONParticipants 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.
Cohort 2b
NO INTERVENTIONParticipants in this cohort will complete a questionnaire about their use of hyperglycemia medications. Participants from Cohort 2a will take part in this group.
Interventions
The therapeutic intervention in this study involves the sulfonylurea glipizide in ER formulation.
Eligibility Criteria
You may qualify if:
- Cohort 1
- Age ≥18 years
- Biopsy-proven PDAC
- Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
- Willing and able to comply with the requirements of the protocol
- Willing to use their bluetooth-enabled wifi or cellular mobile device
- 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
- Eastern Cooperative Oncology Group performance status ≤2
- BMI \<30 kg/m2
- Cohort 2a
- Age ≥18 years
- Biopsy-proven PDAC
- Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic pancreatic cancer)
- Clinical diagnosis of diabetes mellitus
- 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)
- +9 more criteria
You may not qualify if:
- Cohort 1
- 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)
- Changes in metformin dose in the past month
- History of sulfonylurea intolerance or allergy
- History of severe hypoglycemia (hypoglycemia requiring emergency medical assistance, emergency room or urgent care visit, or hospital admission)
- AST or ALT \>3 x upper limit of normal
- Glomerular filtration rate \<30 mL/min/1.73m2
- Daily chronic use of any dose of corticosteroids (as distinct from intermittent exposure to steroids as part of cyclic chemotherapy)
- Inability to wear CGM
- Cohort 2a
- Greater than trace ascites documented on imaging or physical exam
- Cohort 2b
- Greater than trace ascites documented on imaging or physical exam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Flory, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2023
First Posted
December 13, 2023
Study Start
December 5, 2023
Primary Completion (Estimated)
December 5, 2026
Study Completion (Estimated)
December 5, 2026
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
- Access Criteria
- 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.
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.