Compares pancreatic cancer risk in diabetes patients taking exenatide versus other drugs
Studies whether adults with type 2 diabetes taking exenatide have different pancreatic cancer risk.
Key facts
- Who runs it
- AstraZeneca
- Where
- Barcelona, SpainSee the siteAlso in 6 other countries, 7 sites
- Trial code
- Registry title
- A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs
- Status
- Recruiting
- People taking part
- 24,000 people, planned
- Started
- 30 Sept 2024
- Planned end
- 1 Oct 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Exenatide
- Non-GLP-1 RA based glucose lowering drugs
- Record updated
- 24 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study looks at adults with type 2 diabetes who started exenatide or another glucose-lowering drug. It uses past health records to compare the risk of pancreatic cancer.
- Age
- 18 years or older (up to 99 years).
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes diagnosed on or before the day the new drug was started.
- Earlier treatment
- Must have taken a glucose-lowering drug of another class before starting exenatide or the comparison drug. Must not have taken any DPP-4 inhibitor, or any GLP-1 receptor agonist other than exenatide, before.
Main reasons for not taking part
- Type 1 diabetes or diabetes during pregnancy (gestational diabetes)
- Any past cancer, except non-melanoma skin cancer
- Past acute pancreatitis or other diseases of the pancreas
- Polycystic ovarian syndrome with metformin as the only glucose-lowering drug
- Less than 12 months of medical records before starting the drug
The registry criteria, word for word
Show all 14 criteriaShow less
Other criteria
- For inclusion in either exposure group, all of the following inclusion criteria must be fulfilled:
- Aged 18 years or older at the index date
- Individual level data on prescriptions, diagnoses and medical history is available for a minimum of 12 months prior to the index date
- 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:
- 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):
- 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:
- 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:
- 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
- A diagnosis of gestational diabetes during the baseline period or on index date
- 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
- History of any cancer on or prior to index date. The only exception is that nonmelanoma skin cancer does not lead to exclusion
- History of any acute pancreatitis, other diseases of the pancreas, or disorders of the pancreas on or prior to index date
- One or more prescriptions (or dispensed prescriptions) of a GLP-1 RA (incretin mimetics) other than exenatide on or prior to index date
- One or more prescriptions (or dispensed prescriptions) of DPP-4i (incretin mimetics) on or prior to the index date
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Where in Spain
Also in 6 other countries, 7 sites
- BarcelonaHospital not named in the registryTaking people
About the trial
What the trial wants to find out
EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who initiated exenatide compared to those who initiated other non-glucagon like peptide 1 receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be collected from secondary data sources across 7 European countries. The study will be conducted as a multi-country, long-term, retrospective, observational database study. Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs (comparator group) based on propensity score and calendar period of study entry. All analyses for pancreatic cancer will be conducted in the matched study population using an "intention-to-treat" approach. The study will use information from 8 data sources in 7 European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and Sweden). 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. The outcome of pancreatic cancer will be defined as a primary diagnosis of pancreatic cancer during follow-up
The 2 groups in the trial
- Initiators of exenatide
Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide during the study period, 2006 to 2023
Treatment: Exenatide
- Initiators of non-GLP-1 RA based glucose lowering drugs
Patients with T2DM, aged 18 years or older, who initiated treatment with non-GLP-1 RA based glucose lowering drugs during the study period, 2006 to 2023
Treatment: Non-GLP-1 RA based glucose lowering drugs
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- EXCEED - A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs
- Plain-language title
- Compares pancreatic cancer risk in diabetes patients taking exenatide versus other drugsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05663515, who can take part
- Record updated
- 24 September 2026