Using glipizide to lower blood sugar in pancreatic cancer patients
Sulfonylurea Safety and Effectiveness (SUSS) for Patients With Hyperglycemia and Pancreatic Ductal Adenocarcinoma: A Pragmatic Clinical Trial and Accompanying Retrospective Revie
This study is testing if the diabetes medication glipizide can help lower blood sugar and improve health for people with pancreatic cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06168812 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of glipizide, a medication typically used to manage blood sugar levels, in patients diagnosed with pancreatic cancer. Participants will be monitored for their blood sugar levels and overall health while receiving glipizide treatment. The study aims to determine if managing blood sugar can improve outcomes for individuals with this aggressive cancer. Eligible patients must have biopsy-proven pancreatic ductal adenocarcinoma and meet specific blood sugar criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven pancreatic ductal adenocarcinoma and elevated blood sugar levels.
Not a fit: Patients with pancreatic cancer who do not have elevated blood sugar levels or those with a BMI of 30 kg/m2 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help improve blood sugar control and potentially enhance the quality of life for patients with pancreatic cancer.
How similar studies have performed: While the use of glipizide in this context is novel, other studies have explored blood sugar management in cancer patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: James Flory, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: James Flory, MD
- Email: floryj@mskcc.org
- Phone: 646-608-2684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.