ClinicalTrials.gg
RecruitingNCT05663515EXCEEDUpdated Sep 24, 2026

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

An observational study in Pancreatic Cancer, sponsored by AstraZeneca. Recruiting at 8 sites in 7 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by AstraZeneca · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
24,000
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Pancreatic Neoplasms by AstraZeneca — 3 open to participants now, 5 under way, none of them phase 3. Pancreatic Neoplasms · AstraZeneca.

Started
2024
the only one that year
Observational
5 of 19
2 open now
Registered
17th of 19
by date

Among the 19 studies in Pancreatic Neoplasms by AstraZeneca, this one is the only one that started in 2024, is one of 5 observational ones, and was the 17th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

3 of the 19 studies in Pancreatic Neoplasms by AstraZeneca are open now, in 11 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Pancreatic Neoplasms by AstraZeneca, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Pancreatic Cancer
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
24,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Initiators of exenatide

    Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide during the study period, 2006 to 2023

    Drug: 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

    Drug: Non-GLP-1 RA based glucose lowering drugs

Interventions

  • All patients initiating exenatide during the study period will be identified by ATC codes and be included in the exenatide group in a hierarchical manner, regardless of previous use of non-GLP-1 RA based glucose lowering drugs.

    Also known as: BYETTA, BYDUREON/BYDUREON BCise

  • DrugNon-GLP-1 RA based glucose lowering drugs

    Initiators of non-GLP-1 RA based GLDs with no use of exenatide before or during the study period.

    Also known as: Insulin/analogues (excl. A10AE54, A10A56), Biguanide, Sulfonylurea, Sulfonamide (heterocycl.), combined oral GLD (excl. DPP-4i), Alpha glucose inhib., Thiazolidinedione, SGLT2i, Oth. GLD excl. insulin

06

What researchers measure

Primary outcomes

  1. Incidence rate of primary diagnosis of pancreatic cancer among exenatide exposed population

    To estimate the incidence rate (IR) for pancreatic cancer associated with exposure to exenatide, compared with exposure to non-GLP-1 RA based GLDs, among patients with T2DM.

    Time frame: Follow-up starts from the index date to the study completion, an average of 1.5 years or less

  2. Hazard ratio of primary diagnosis of pancreatic cancer among exenatide exposed population

    To estimate the hazard ratio (HR) for pancreatic cancer associated with exposure to exenatide, compared with exposure to non-GLP-1 RA based GLDs, among patients with T2DM

    Time frame: Follow-up starts from thr index date to the study completion, an average of 1.5 years or less

07

Study locations

8 of 8 sites recruiting
  • Research Site
    Copenhagen, Denmark
    Recruiting
  • Research Site
    Helsinki, Finland
    Recruiting
  • Research Site
    Paris, France
    Recruiting
  • Research Site
    Bergen, Norway
    Recruiting
  • Research Site
    Barcelona, Spain
    Recruiting
  • Research Site
    Vänersborg, Sweden
    Recruiting
  • Research Site
    Edinburgh, United Kingdom
    Recruiting
  • Research Site
    London, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2022
First posted
Dec 23, 2022
StartActual
Sep 30, 2024
Primary completionEst.
Oct 1, 2026
CompletionEst.
Oct 1, 2026
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05663515
Lead sponsor
AstraZeneca
Collaborators
IQVIA Pvt. Ltd
Responsible party
Sponsor
First posted
Dec 23, 2022
Start date
Sep 30, 2024
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Sep 24, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479
Fabian Hoti, PhD
principal investigator · IQVIA Pty Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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