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EXCEED

Recruiting

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

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

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

8

Recruiting sites

8

Enrollment

24,000

estimated

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

Incidence rate of primary diagnosis of pancreatic cancer among exenatideHazard ratio of primary diagnosis of pancreatic cancer among exenatide exposed

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05663515
Org study IDD5551R00015

Timeline

Milestones

Study first posted2022-12-23actual
Study start2024-09-30actual
Last update posted2026-06-02actual
Primary completion2026-10-01estimated
Study completion2026-10-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

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

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

event count, event

Primary/protocol endpoint

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

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

time to event, event

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.