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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called glipizide to see if it can help lower high blood sugar levels in people diagnosed with pancreatic cancer. The researchers want to find out if glipizide is both effective and safe for this purpose. They are currently looking for participants aged 18 and older who have been confirmed to have pancreatic cancer and have high blood sugar levels. Participants will need to use a Bluetooth-enabled device to help monitor their health during the study.

To join the trial, participants must meet certain criteria, such as having an active form of pancreatic cancer and a specific level of high blood sugar. They should also be receiving care for their cancer at least once every three months. Throughout the study, participants will be monitored closely to track how well glipizide works for managing their blood sugar. This trial aims to provide valuable information that could improve treatment options for people with pancreatic cancer and high blood sugar.

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Eligibility 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%, or fructosamine \>325 mg/dL, or 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