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

• Status: Recruiting
• Trial end date: 2025-12-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Glipizide

Criteria

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