Diabetes drug exenatide under scrutiny for cancer link
NCT ID NCT05663515
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
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About 24,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
8 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Research Site
RECRUITINGCopenhagen, Denmark
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Research Site
RECRUITINGHelsinki, Finland
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Research Site
RECRUITINGParis, France
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Research Site
RECRUITINGBergen, Norway
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Research Site
RECRUITINGBarcelona, Spain
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Research Site
RECRUITINGVänersborg, Sweden
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Research Site
RECRUITINGEdinburgh, United Kingdom
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Research Site
RECRUITINGLondon, United Kingdom
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