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OpenTrials
Active, Not Recruiting

NCT Number: NCT06168812

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) > 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)
  • 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 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

Treatment and study plan

Glipizide

Drug

The therapeutic intervention in this study involves the sulfonylurea glipizide in ER formulation.

Other names: sulfonylurea glipizide, Glucotrol

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • University of California, Berkeley

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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