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Pancreatic CancerPhase 2NCT06168812

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

A Phase 2 study testing Glipizide in people with Pancreatic Cancer and Pancreatic Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Glipizide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
7 sitesUnited States
Study dates
5 Dec 2023to 5 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

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

    Basking Ridge, New Jersey, 07920

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

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

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

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

Being tested
Glipizide
Keywords
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
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlipizideDrug

    Also called sulfonylurea glipizide, Glucotrol

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

Study groups in NCT06168812
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants 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.
Receives: Drug: Glipizide
Cohort 2aNo interventionParticipants 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.
Cohort 2bNo interventionParticipants in this cohort will complete a questionnaire about their use of hyperglycemia medications. Participants from Cohort 2a will take part in this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 48 hours after glipizide initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2023
  2. Study start5 Dec 2023
  3. Primary completion5 Dec 2026 (estimated)
  4. Study completion5 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06168812
Sponsor's protocol ID
23-318
Status last verified
Aug 2026
First submitted
5 Dec 2023
Last updated
6 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glipizide in people with Pancreatic Cancer and Pancreatic Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide (time frame: 48 hours after glipizide initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06168812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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