A Study Of Glipizide To Treat High Blood Sugar In People With Pancreatic Cancer

Study Overview

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.

N/A

Pancreatic Cancer
Pancreatic Carcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer Metastatic
Metastatic Pancreatic Cancer
Metastatic Pancreatic Ductal Adenocarcinoma

DRUG: Glipizide

23-318

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-12-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-13
First Submitted that Met QC Criteria 2023-12-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-14
First Posted (ACTUAL) 2023-12-13	Results First Posted N/A	Last Verified 2025-08

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

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.
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 standa
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.

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.

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 standa

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.

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

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

Name: James Flory, MD

Phone Number: 646-608-2684

Email: floryj@mskcc.org

Study Contact Backup

Name: Eileen O'Reilly, MD

Phone Number: 646-888-4182

Email: oreillye@MSKCC.ORG

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

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

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

Greater than trace ascites documented on imaging or physical exam

Greater than trace ascites documented on imaging or physical exam

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: James Flory, MD, Memorial Sloan Kettering Cancer Center

Publications

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

General Publications

No publications available

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Resources

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Clinical Trial Record