Clinical trial NCT06168812: A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer
Official title: Sulfonylurea Safety and Effectiveness (SUSS) for Patients With Hyperglycemia and Pancreatic Ductal Adenocarcinoma: A Pragmatic Clinical Trial and Accompanying Retrospective Revie
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Pancreatic Carcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer Metastatic
Metastatic Pancreatic Cancer
Metastatic Pancreatic Ductal Adenocarcinoma
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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) \&gt;8%, or fructosamine \&gt;325 mg/dL, or random glucose \&gt;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 \&lt;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 \&gt;3 x upper limit of normal
* Glomerular filtration rate \&lt;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

Primary outcomes:
measure: Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide
timeFrame: 48 hours after glipizide initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Flory, MD
role: PRINCIPAL_INVESTIGATOR
References: