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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Pancreatic Cancer Metastatic; Metastatic Pancreatic Cancer; Metastatic Pancreatic Ductal Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Carcinoma; Pancreatic Cancer

Treatments: Drug: Glipizide

Study type: Interventional

Funder types: Other

Identifiers

NCT06168812

23-318

Details and patient eligibility

About

The purpose of this study is to find out how effective and safe glipizide is for lowering blood sugar in people with pancreatic cancer.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Participants in this cohort will receive glipizide for up to 4 months and participate in continuous glucose monitoring for as long as they are receiving the drug.

Treatment:

Drug: Glipizide

Cohort 2a

No Intervention group

Description:

Participants in this cohort will include people who have received various types of treatment for their hyperglycemia and pancreatic cancer. People's medical records will be reviewed to compare the effects of glipizide with the effects of other standard medications used to treat hyperglycemia.

Cohort 2b

No Intervention group

Description:

Participants in this cohort will complete a questionnaire about their use of hyperglycemia medications. Participants from Cohort 2a will take part in this group.