Status: Planned
First registered on:
24/11/2021
Last updated on:
11/04/2023
1. Study identification
EU PAS Register NumberEUPAS32646
Official titleDulaglutide and Potential Risks of Pancreatic Cancer and Thyroid Cancer: A Non-Interventional PASS
Study title acronymH9X-MC-B013
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?No
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 applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research group
Organisation/affiliationIQVIA
Details of (Primary) lead investigator
Title Dr
Last name GPS Pharmacoepidemiology
First name Lilly
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
Finland
Sweden
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/11/2019
Start date of data collection31/03/2024
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2030
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly & Co.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name GPS Pharmacoepidemiology
First name Lilly
Address line 1Lilly Corporate Center
Address line 2
Address line 3
CityIndianapolis
Postcode46285
CountryUnited States
Phone number (incl. country code)3172762000
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name GPS Pharmacoepidemiology
First name Lilly
Address line 1Lilly Corporate Center
Address line 2
Address line 3
CityIndianapolis
Postcode46285
CountryUnited States
Phone number (incl. country code)3172762000
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Single-Constituent (Substance INN)Dulaglutide
7. Medical conditions to be studied
Medical condition(s)Yes
Pancreatic cancer
Thyroid cancer
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects325000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
The Military Health System Data Repository (MDR), United States
Swedish National Registers, Sweden
Finnish National Registers, Finland
Sources of data
Disease/case registry
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To estimate the incidence rates and evaluate the potential association of pancreatic cancer and thyroid cancer (including subtypes: Papillary, Follicular, and Medullary [C-cell tumour]) for patients with T2DM who initiated dulaglutide compared to those who initiated other non-incretin second-line ADMs.
Are there primary outcomes?Yes
Pancreatic cancer, thyroid cancer
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
The primary analysis will be an intention to treat (ITT) approach, in which pancreatic cancer and thyroid cancer will be assessed any time after the end of an exposure latency period of 3-years. Cox proportional hazards regression with matching on the exposure propensity score (EPS) to control for the potential confounders will be applied to compare exposure groups with respect to the outcomes of interest.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
