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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168812
• Other study ID #: 23-318
• Status: Recruiting
• Phase: Phase 2
• Start date: December 5, 2023
• Est. completion date: December 5, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: James Flory, MD
• Phone: 646-608-2684
• Email: floryj[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 5, 2025
• Est. primary completion date: December 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 at home (sporadic insulin use [fewer than 1 of 7 days during the past month] is permitted)

• 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

• Greater than trace ascites documented on imaging or physical exam

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Cancer
• Metastatic Pancreatic Ductal Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Cancer Metastatic
• Pancreatic Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• Glipizide
The therapeutic intervention in this study involves the sulfonylurea glipizide in ER formulation.

Locations

Country	Name	City	State
United States	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 Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center