ACTIVE_NOT_RECRUITING

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

Conditions

Pancreatic Cancer Pancreatic Carcinoma Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Metastatic Metastatic Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Glipizide Memorial Sloan Kettering Cancer Center 23-318

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-12-05

Study Completion:2026-12-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06168812

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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

Inclusion Criteria

Exclusion Criteria

* 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

Contacts and Locations

Principal Investigator

James Flory, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

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

Study Start Date2023-12-05

Study Completion Date2026-12-05

Study Record Updates

Study Start Date2023-12-05

Study Completion Date2026-12-05

Terms related to this study

Keywords Provided by Researchers

Pancreatic Cancer
Pancreatic Carcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer Metastatic
Metastatic Pancreatic Cancer
Metastatic Pancreatic Ductal Adenocarcinoma
Glipizide
Memorial Sloan Kettering Cancer Center
23-318

Additional Relevant MeSH Terms

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