Metastatic Pancreatic Cancer, Metastatic Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreatic Cancer Metastatic, Pancreatic Carcinoma, Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Pancreatic Cancer, Pancreatic Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Metastatic, Metastatic Pancreatic Cancer, Metastatic Pancreatic Ductal Adenocarcinoma, Glipizide, Memorial Sloan Kettering Cancer Center, 23-318
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.
Interventions
DRUGGlipizide
The therapeutic intervention in this study involves the sulfonylurea glipizide in ER formulation.
Sponsors
Memorial Sloan Kettering Cancer Center
University of California, Berkeley
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) \> 7%, or fructosamine \> 287 mg/dL, or random glucose \> 180 mg/dL, or strong clinical suspicion that patient has hyperglycemia, making it reasonable to expect their mean daily glucose is ≥154 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAzeez Farooki, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed