Een pan-Europees veiligheidsonderzoek na vergunningverlening: risico op alvleesklierkanker bij patiënten met type 2-diabetes die met exenatide begonnen in vergelijking met degenen die met andere niet-glucagonachtige peptide-1-receptoragonisten begonnen met glucoseverlagende geneesmiddelen (EXCEED)
EXCEED - Een pan-Europese post-autorisatie veiligheidsstudie: risico op alvleesklierkanker bij patiënten met diabetes type 2 die begonnen met exenatide in vergelijking met degenen die begonnen met andere niet-glucagon-achtige peptide-1-receptoragonisten gebaseerde glucoseverlagende geneesmiddelen
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: AstraZeneca Clinical Study Information Center
- Telefoonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studie Locaties
-
-
-
Copenhagen, Denemarken
- Werving
- Research Site
-
-
-
-
-
Helsinki, Finland
- Werving
- Research Site
-
-
-
-
-
Paris, Frankrijk
- Werving
- Research Site
-
-
-
-
-
Bergen, Noorwegen
- Werving
- Research Site
-
-
-
-
-
Barcelona, Spanje
- Werving
- Research Site
-
-
-
-
-
Edinburgh, Verenigd Koninkrijk
- Werving
- Research Site
-
London, Verenigd Koninkrijk
- Werving
- Research Site
-
-
-
-
-
Vänersborg, Zweden
- Werving
- Research Site
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: RETROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Initiators of exenatide
Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide during the study period, 2006 to 2023 |
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.
Andere namen:
|
|
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 |
Initiators of non-GLP-1 RA based GLDs with no use of exenatide before or during the study period.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence rate of primary diagnosis of pancreatic cancer among exenatide exposed population
Tijdsspanne: Follow-up starts from the index date to the study completion, an average of 1.5 years or less
|
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. |
Follow-up starts from the index date to the study completion, an average of 1.5 years or less
|
|
Hazard ratio of primary diagnosis of pancreatic cancer among exenatide exposed population
Tijdsspanne: Follow-up starts from thr index date to the study completion, an average of 1.5 years or less
|
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 |
Follow-up starts from thr index date to the study completion, an average of 1.5 years or less
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Fabian Hoti, PhD, IQVIA Pty Ltd
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Neoplasmata per site
- Neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Endocriene klierneoplasmata
- Alvleesklier Ziekten
- Pancreasneoplasmata
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Peptide hormonen
- Peptiden
- Aminozuren, peptiden en eiwitten
- Zwavelverbindingen
- Organische chemicaliën
- Biologische factoren
- Amides
- Complexe mengsels
- Guanidines
- Amidines
- Sulfonen
- Insulines
- Pancreashormonen
- Gifstoffen, biologisch
- Ureum
- Proinsuline
- Gif
- Exenatide
- Insuline
- Biguaniden
- 2,4-thiazolidinedion
- Sulfonylureumverbindingen
- Sulfonamides
Andere studie-ID-nummers
- D5551R00015
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
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.
IPD-toegangscriteria voor delen
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .