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

NCT ID: NCT06168812

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2026-12-05

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Glipizide

Intervention Type DRUG

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Glipizide

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

Intervention Type DRUG

Other Intervention Names

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sulfonylurea glipizide Glucotrol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Berkeley

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Flory, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Site Status

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

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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23-318

Identifier Type: -

Identifier Source: org_study_id

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