Status: Planned First registered on: 06/04/2021
Last updated on: 19/07/2023
1. Study identification
EU PAS Register NumberEUPAS31458
Official titleA 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
Study title acronymEXCEED
Study typeObservational study
Brief description of the studyEXCEED 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)N/A
Other study registration identification numbers and URLs as applicableN/A
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research groupGloDaSt, IQVIA
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Hoti
First name Fabian
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Denmark
Finland
France
Norway
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/06/201917/06/2019
Start date of data collection01/01/2024
Start date of data analysis01/01/2024
Date of interim report, if expected
Date of final study report31/12/2025
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Hoti
First name Fabian
Address line 1Metsänneidonkuja 06
Address line 2 
Address line 3 
CityEspoo 
PostcodeFI-02130 
CountryFinland
Phone number (incl. country code)358-405391919 
Alternative phone number 
Fax number (incl. country code) 
Email address PAS_registrations@iqvia.com
Public Enquiries
Title Dr 
Last name Hoti 
First name Fabian 
Address line 1Metsänneidonkuja 06 
Address line 2 
Address line 3 
CityEspoo 
PostcodeFI-02130 
CountryFinland 
Phone number (incl. country code)358-405391919 
Alternative phone number 
Fax number (incl. country code) 
Email address PAS_registrations@iqvia.com 
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