To examine the impact of additional confounder adjustment for the potential association between second line T2DM therapy and thyroid cancer: a nested case-control study (GLP1i and thyroid cancer)

Study identification

• EU PAS number:
  EUPAS106600
• Study ID:
  106601
• Official title and acronym:
  To examine the impact of additional confounder adjustment for the potential association between second line T2DM therapy and thyroid cancer: a nested case-control study (GLP1i and thyroid cancer)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A recent nested case-control analysis performed in the SNDS database (Bezin et al, 2023) showed an association with an increased risk of all thyroid cancer and medullary thyroid cancer with use of Glucagon-like peptide-1 agonists (GLP-1 RA) in people with T2DM, in particular after 1–3 years of cumulative treatment. However, it was not possible to adjust for certain potential confounders in the association with thyroid cancer that were not captured in that database, such as smoking status or body mass index. Our study aims to examine the potential impact of adjusting for missing confounders on the association with thyroid cancer in people with T2DM by attempting to reproduce the design of the French NCCS study.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 20/06/2023

Actual: 20/06/2023

Study start date

Planned: 01/08/2023

Actual: 01/08/2023

Data analysis start date

Planned: 15/08/2023

Actual: 15/08/2023

Date of final study report

Planned: 01/09/2023

Actual: 01/09/2023

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable