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Diabetes drug exenatide under scrutiny for cancer link

NCT ID NCT05663515

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 05, 2026 · Updated 3 times

Summary

This study is checking if the diabetes medicine exenatide (Byetta, Bydureon) increases the risk of pancreatic cancer. Researchers will look at health records from 24,000 patients across seven European countries, comparing those who started exenatide with those who started other diabetes drugs. The goal is to see if there is a difference in how many people develop pancreatic cancer over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Exenatide (also known as Byetta, Bydureon/Bydureon BCise)
What this could lead to
If this study finds no increased risk, it could provide reassurance about the long-term safety of exenatide for diabetes patients.
What could go wrong
This is an observational study, not a controlled trial, so it can only show links, not cause and effect. Results may be influenced by other factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 24,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

For inclusion in either exposure group, all of the following inclusion criteria must be fulfilled: 1. Aged 18 years or older at the index date 2. Individual level data on prescriptions, diagnoses and medical history is available for a minimum of 12 months prior to the index date 3. A diagnosis of T2DM on index date or prior to index date For inclusion in the overall exenatide exposure group, the following criterion must be fulfilled: 1. One incident prescription (or incident dispensed prescription) for exenatide (BYETTA or BYDUREON/ BYDUREON BCise) between the start and 12 months before the end of the study period. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period. For inclusion in the BYDUREON/ BYDUREON BCise exposure group, for the analyses of the secondary objective, the criterion a) is substituted with criterion b): 2. One incident prescription (or incident dispensed prescription) for BYDUREON/ BYDUREON BCise between the start and 12 months before the end of the study period. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period. For inclusion in the comparator group, the following criterion must be fulfilled: 3. One incident prescription (or incident dispensed prescription) of a GLD between the start and 12 months before the end of the study period. The GLD must not be a DPP-4i, a GLP-1 RA, or a combination with either a DPP-4i or a GLP-1 RA. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period. Patients are not eligible for any of the study population groups if they fulfil any of the following exclusion criteria: 1. A diagnosis of type 1 diabetes mellitus (T1DM) on index date or a diagnosis of T1DM during the baseline period that is not succeeded by a T2DM diagnosis during the remaining part of the baseline period. 2. A diagnosis of gestational diabetes during the baseline period or on index date. 3. A diagnosis of polycystic ovarian syndrome during the baseline period or on index date in combination with exposure to metformin (Anatomical Therapeutic Chemical Classification System (ATC) code of the World Health Organization (WHO): A10BA02) as the only GLD on index date or during the baseline period. 4. History of any cancer on or prior to index date. The only exception is that nonmelanoma skin cancer does not lead to exclusion. 5. History of any acute pancreatitis, other diseases of the pancreas, or disorders of the pancreas on or prior to index date. 6. One or more prescriptions (or dispensed prescriptions) of a GLP-1 RA (incretin mimetics) other than exenatide on or prior to index date. 7. One or more prescriptions (or dispensed prescriptions) of DPP-4i (incretin mimetics) on or prior to the index date.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Copenhagen, Denmark

  • Research Site

    RECRUITING

    Helsinki, Finland

  • Research Site

    RECRUITING

    Paris, France

  • Research Site

    RECRUITING

    Bergen, Norway

  • Research Site

    RECRUITING

    Barcelona, Spain

  • Research Site

    RECRUITING

    Vänersborg, Sweden

  • Research Site

    RECRUITING

    Edinburgh, United Kingdom

  • Research Site

    RECRUITING

    London, United Kingdom

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