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Anti-diabetic agent

Cohort 1 for Pancreatic Cancer

Phase 2

Recruiting

Led By James Flory, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after glipizide initiation

Awards & highlights

Study Summary

This trial tests if glipizide is a safe and effective way to lower blood sugar in people with pancreatic cancer. #medicine

Who is the study for?

This trial is for adults over 18 with metastatic pancreatic cancer and high blood sugar levels, who haven't had certain diabetes treatments or surgeries like Whipple surgery. They should be able to use a mobile device with Bluetooth and follow the study's protocol. People are excluded if they have a history of severe hypoglycemia, certain liver issues, very low kidney function, significant fluid in the abdomen, or daily steroid use.Check my eligibility

What is being tested?

The trial is testing how well Glipizide can lower blood sugar in people with advanced pancreatic cancer. It aims to determine both the effectiveness and safety of this medication specifically for these patients.See study design

What are the potential side effects?

Glipizide may cause side effects such as low blood sugar (hypoglycemia), which can lead to symptoms like dizziness, sweating, hunger, irritability or mood changes. Other possible side effects include skin reactions at injection sites and digestive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after glipizide initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after glipizide initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after glipizide initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 1Experimental Treatment1 Intervention

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.

Group II: Cohort 2aActive Control1 Intervention

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.

Group III: Cohort 2bActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glipizide

2007

Completed Phase 4

~6180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,858 Total Patients Enrolled

James Flory, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

3 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are involved in the research project?

"Absolutely. As per the hosted clinicaltrials.gov data, this study is actively recruiting patients and was first posted on December 5th 2023 with its most recent edit occuring on the same day. The trial hopes to enrol 230 participants across 7 different medical centres."

Answered by AI

Is there still space available to enroll in the experiment?

"Affirmative, the information found on clinicaltrials.gov evidences that this trial is currently enrolling participants. Initially published in December 5th 2023 and recently modified around the same date, it seeks to recruit 230 patients from seven distinct medical centres."

Answered by AI

Has Cohort 1 been granted authorization by the FDA?

"With a score of 2, the researchers at Power deem Cohort 1 to be moderately safe due to Phase 2 trial data which suggests that while it is safe, there's no evidence yet for its efficacy."

Answered by AI

Do any research centers in North America have this study taking place?

"At the time of writing, seven different medical centres are accepting patients for this trial. These locations include Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) in Commack, Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) in Basking Ridge and Memorial Sloan Kettering Monmouth (Limited protocol activities) in Middletown as well as four other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06168812.