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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06168812
Other study ID # 23-318
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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