A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer

April 22, 2024 updated by: Memorial Sloan Kettering Cancer Center

Sulfonylurea Safety and Effectiveness (SUSS) for Patients With Hyperglycemia and Pancreatic Ductal Adenocarcinoma: A Pragmatic Clinical Trial and Accompanying Retrospective Revie

The purpose of this study is to find out how effective and safe glipizide is for lowering blood sugar in people with pancreatic cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
        • Contact:
          • James Flory, MD
          • Phone Number: 646-608-2684
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
        • Contact:
          • James Flory, MD
          • Phone Number: 646-608-2684
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • James Flory, MD
          • Phone Number: 646-608-2684
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
        • Contact:
          • James Flory, MD
          • Phone Number: 646-608-2684
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
        • Contact:
          • James Flory, MD
          • Phone Number: 646-608-2684
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • James Flory, MD
          • Phone Number: 646-608-2684
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
        • Contact:
          • James Flory, MD
          • Phone Number: 646-608-2684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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) >8%, fructosamine >325 mg/dL, random glucose >200 mg/dL, or strong clinical suspicion that patient has hyperglycemia, making it reasonable to expect their mean daily glucose is ≥183 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)
  • At least 1 electronic prescription for a sulfonylurea (glipizide, glimepiride, or glyburide) or metformin
  • Three-month baseline period before metformin or sulfonylurea initiation in which the participant does not receive either drug class or insulin
  • Body weight recorded within 3 months before start of metformin or a sulfonylurea

Cohort 2b

  • Age ≥18 years
  • Biopsy-proven PDAC
  • Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
  • Active care at MSK (defined as at least 1 physician or APP encounter every 3 months) for PDAC during the period of data collection
  • Apparent current use based on chart review of metformin (but not sulfonylurea); sulfonylurea (but not metformin); or neither drug

Exclusion Criteria:

Cohort 1

  • Use during the past month of any antidiabetic medication at home (sporadic insulin use [fewer than 1 of 7 days during the past month] is permitted)
  • 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
  • Greater than trace ascites documented on imaging or physical exam
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
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.
Drug: Glipizide
The therapeutic intervention in this study involves the sulfonylurea glipizide in ER formulation.
Other Names:
  • Glucotrol
  • sulfonylurea glipizide
No Intervention: Cohort 2a
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.
No Intervention: Cohort 2b
Participants in this cohort will complete a questionnaire about their use of hyperglycemia medications. Participants from Cohort 2a will take part in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide
Time Frame: 48 hours after glipizide initiation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: James Flory, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

December 5, 2025

Study Completion (Estimated)

December 5, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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