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

Phase 2

Recruiting

• Conditions: Pancreatic Cancer Metastatic; Pancreatic Carcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer
• Interventions: Drug: Glipizide

• Registration Number: NCT06168812
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-05
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12-05
• Study Completion: 2025-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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) >8%, fructosamine >325 mg/dL, random glucose >200 mg/dL, or strong clinical suspicion that patient has hyperglycemia, making it reasonable to expect their mean daily glucose is ≥183 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Glipizide	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.

Primary Outcome Measures

Name	Time	Method
Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide	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

Trial Locations

Locations (7)

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

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States