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

Last updated: February 12, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Cancer

Carcinoma

Metastatic Cancer

Treatment

Glipizide

Clinical Study ID

NCT06168812
23-318
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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%, or fructosamine >325 mg/dL, or random glucose >200 mg/dL, or strong clinical suspicion that patient has hyperglycemia, makingit 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 medicalrecord (in this retrospective study patients need not be under active care at thetime the research is conducted)

  • At least 1 electronic prescription for a sulfonylurea (glipizide, glimepiride, orglyburide) or metformin

  • Three-month baseline period before metformin or sulfonylurea initiation in which theparticipant 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

Exclusion Criteria:

Cohort 1

  • Use during the past month of any antidiabetic medication other than metformin athome (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 intermittentexposure 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 Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Glipizide
Phase: 2
Study Start date:
December 05, 2023
Estimated Completion Date:
December 05, 2025

Connect with a study center

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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