Status: Planned First registered on: 21/09/2020
Last updated on: 24/11/2020
1. Study identification
EU PAS Register NumberEUPAS37258
Official titleNN9535-4447 Epidemiological assessment of the risk for pancreatic cancer associated with the use of Ozempic® (semaglutide s.c.) in patients with type 2 diabetes- A cohort study based on Nordic registry data
Study title acronym
Study typeObservational study
Brief description of the studyThe aim of this study is to evaluate whether exposure to Ozempic® increases the risk of pancreatic cancer in patients with type 2 diabetes. This is achieved by estimating the risk of pancreatic cancer associated with Ozempic® use as compared to use of other antidiabetic drugs used at a similar stage as Ozempic® in the treatment cascade in the type 2 diabetes population. A multi-national, non-interventional study based on health care data from Denmark, Sweden, and Norway is conducted during the period 2018-2023. A cohort study design is used comparing new users of Ozempic® with new users of other antidiabetic drugs used at a similar stage as Ozempic® in the treatment cascade in the type 2 diabetes population (active comparators). Active comparators will include the following antidiabetic agents: sulphonylureas, sodium-glucose co-transporter 2 inhibitors, and insulin. Propensity scores are used to match new users of Ozempic® with new users of active comparators. National prescription-, cancer- and patient registries are used to identify exposure to antidiabetic agents, pancreatic cancer cases, and covariates to be used in propensity score matching. This study is a post-authorisation safety study (PASS).
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)
Other study registration identification numbers and URLs as applicableUTN- U1111-1214-6228
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUniversity of Southern Denmark Pharmacoepi center
Department/Research groupOdense University Pharrnacoepidemiological Database
Organisation/affiliationUniversity of Southern Denmark
Website/Homepage
Details of (Primary) lead investigator
Title Professor
Last name Pottegård
First name Anton
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?1

University of Southern Denmark Pharmacoepi center
Countries in which this study is being conducted
International study

Denmark
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/11/201801/11/2018
Start date of data collection01/12/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report01/08/2025
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovo Nordisk A/S100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Pottegård
First name Anton
Address line 1Clinical Pharmacology and Pharmacy
Address line 2JB Winsløws Vej 19, 2nd 
Address line 3 
CityOdense C 
Postcode5000 
CountryDenmark
Phone number (incl. country code)45-65503024 
Alternative phone number 
Fax number (incl. country code) 
Email address apottegaard@health.sdu.dk
Public Enquiries
Title Ms 
Last name Novo Nordisk A/S 
First name Clinical Transparency (dept. 1452) 
Address line 1Novo Allé 
Address line 2 
Address line 3 
CityBagsvaerd 
Postcode2880 
CountryDenmark 
Phone number (incl. country code)45-44448888 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltrials@novonordisk.com 
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