Monitoring and Managing Glucose Levels in People With Pancreatic Cancer (PEGASUS)

September 17, 2025 updated by: British Columbia Cancer Agency

Pancreatic Cancer Glucose Assessment and Regulation Study

This study will investigate whether or not it is feasible to closely monitor and manage glucose levels in people with pancreatic cancer. It will also investigate what impact glucose management may have on pancreatic cancer.

This is a pilot study that will use continuous glucose monitors (CGM) to monitor glucose levels in approximately 50 participants with pancreatic cancer. Participants will receive standard chemotherapy with a combination of up to four drugs to treat their pancreatic cancer: oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin (FOLFIRINOX). To treat high glucose levels, participants will be randomly assigned to one of two groups: Group 1 will receive anti-hyperglycemic treatment as guided by an endocrinologist with the aim of maintaining glucose levels between 4 and 10 mmol/L; Group 2 will receive anti-hyperglycemic treatment if their glucose levels are above 15 mmol/L, which is standard care. Participants in both Groups 1 and 2 will receive standard anti-hyperglycemic treatments: metformin, insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose co-transporter (SGLT2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors.

After 4 cycles of FOLFIRINOX, the CGM will be removed but any anti-hyperglycemic treatments will continue as needed. If participants discontinue treatment with FOLFIRINOX, they will continue to be followed for survival and subsequent anti-cancer therapy and will continue follow-up for glucose-related concerns at the discretion of their endocrinologist and/or medical oncologist.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • British Columbia Cancer
        • Principal Investigator:
          • Daniel Renouf, MD, MPH
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Planned to undergo first-line systemic therapy with FOLFIRINOX.
  • Age greater than or equal to 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

  • Adequate bone marrow and organ function as defined by the following laboratory values:

    1. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L.
    2. Platelet count greater than or equal to 75 x 10^9/L.
    3. Hemoglobin greater than or equal to 9.0 g/dL.
    4. Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
    5. Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
    6. Potassium within normal limits, or corrected with supplements.
    7. International normalized ratio (INR) less than or equal to 1.5.
    8. Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin less than or equal to 3 x ULN or direct bilirubin less than or equal to 1.5 x ULN).
    9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present).
  • Able to understand and voluntarily sign the informed consent form.
  • Able to comply with the study visit schedule and other protocol requirements.
  • Able to swallow oral medications and has no contraindications to subcutaneous insulin injections.
  • Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline.
  • Life expectancy of more than 90 days as judged by the study doctor.

Exclusion Criteria:

  • Absence of distant or lymph node metastases. Participants with borderline resectable or locally advanced PDAC are not eligible.
  • Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
  • Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent).
  • Not fit for combination chemotherapy as judged by the study doctor.
  • Presence of brain metastases.
  • Known diagnosis of type I diabetes where strict glucose control and close Endocrinology follow-up is already indicated.
  • Known diagnosis of type II diabetes and already followed by Endocrinologist.
  • Female participants with a positive pregnancy test.
  • Participants who are not safe to include in the study as judged by the study doctor for any medical or non-medical reason.
  • Unable to comply with study assessments and follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive Glucose Intervention
Participants will receive standard anti-hyperglycemic treatment as guided by an endocrinologist using a combination of data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Treatment will aim to maintain glucose levels between 4 and 10 mmol/L. Participants will have real-time access to their glucose data via the CGM.
Procedure: Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)
Standard anti-hyperglycemic treatment given as directed by an endocrinologist to maintain blood glucose level within 4-10 mmol/L based on data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Participants will have access to their glucose data from the CGM.
Other: Standard Care
Participants will receive standard anti-hyperglycemic treatment only if blood glucose level is above 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a CGM but will not be able to view their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.
Other: Standard Care
Standard anti-hyperglycemic treatment given only if blood glucose level is greater than 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a continuous glucose monitor (CGM) but will not have access to their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of glucose levels maintained within range in Arm 1 compared to Arm 2
Time Frame: From the Cycle 4 FOLFIRINOX treatment date to the Cycle 5 FOLFIRINOX treatment date (each cycle is typically 14 days).
The percentage of time each participant's glucose levels in Arm 1 and Arm 2 remained within the 4-10 mmol/L range during the fourth cycle of FOLFIRINOX treatment as measured by a continuous glucose monitor.
From the Cycle 4 FOLFIRINOX treatment date to the Cycle 5 FOLFIRINOX treatment date (each cycle is typically 14 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) in each study arm, as defined by RECIST 1.1
Time Frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
The proportion of participants in each study arm who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.
From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
Progression-free survival (PFS) in each study arm from the initiation of FOLFIRINOX
Time Frame: From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm.
From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
Overall survival (OS) in each study arm from the initiation of FOLFIRINOX
Time Frame: From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.
The length of time from the initiation of FOLFIRINOX that participants survive in each study arm.
From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 and stratified by prognostic and metabolic gene expression subtypes of PDAC
Time Frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
The proportion of participants in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.
From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
Progression-free survival (PFS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX
Time Frame: From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC.
From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
Overall survival (OS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX
Time Frame: From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.
The length of time from the initiation of FOLFIRINOX that participants survive in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC.
From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.
Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 and stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles
Time Frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
The proportion of participants in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.
From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
Progression-free survival (PFS) in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of FOLFIRINOX
Time Frame: From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.
From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
Overall survival (OS) in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of FOLFIRINOX
Time Frame: From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.
The length of time from the initiation of FOLFIRINOX that participants survive in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.
From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.
Amount of insulin, measured in molar, for participants in each study arm from screening until the end of study visit
Time Frame: From the date of screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
The quantity of insulin, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.
From the date of screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
Amount of proinsulin, measured in molar, for participants in each study arm from screening until the end of study visit
Time Frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
The quantity of proinsulin, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.
From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
Amount of C-peptide, measured in molar, for participants in each study arm from screening until the end of study visit
Time Frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
The quantity of C-peptide, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.
From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
Amount of circulating biomarkers, measured in molar, for participants in each study arm from screening until the end of study visit
Time Frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
The quantity of circulating biomarkers, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.
From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

University Health Network, Toronto
University of British Columbia
Lustgarten Foundation

Investigators

  • Principal Investigator: Daniel Renouf, MD, MPH, BC Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-03061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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