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

Study Overview
=================
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.

Official Title
-----------------
Sulfonylurea Safety and Effectiveness (SUSS) for Patients With Hyperglycemia and Pancreatic Ductal Adenocarcinoma: A Pragmatic Clinical Trial and Accompanying Retrospective Revie

Conditions
-----------------
Pancreatic Cancer, Pancreatic Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Metastatic, Metastatic Pancreatic Cancer, Metastatic Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Glipizide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cohort 1 Age ≥18 years Biopsy-proven PDAC Radiological evidence and clinical assessment that disease is 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 disease is metastatic 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 disease is 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 History of distal pancreatectomy or of Whipple surgery History of diabetes diagnosed 2 years or more prior to pancreas cancer diagnosis 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 History of distal pancreatectomy or of Whipple surgery Greater than trace ascites documented on imaging or physical exam Cohort 2b History of distal pancreatectomy or of Whipple surgery Greater than trace ascites documented on imaging or physical exam

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>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. | Drug: Glipizide<br>* The therapeutic intervention in this study involves the sulfonylurea glipizide in ER formulation.<br>* Other names: Glucotrol;|
| No Intervention: Cohort 2a<br>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. | |
| No Intervention: Cohort 2b<br>Participants in this cohort will complete a questionnaire about their use of hyperglycemia medications. Participants from Cohort 2a will take part in this group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide | 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 | 48 hours after glipizide initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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