Dulaglutide and Potential Risks of Pancreatic Cancer and Thyroid Cancer: A Non-Interventional PASS (H9X-MC-B013)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49022
• EU PAS number:
  EUPAS32646
• Study ID:
  49022
• Official title and acronym:
  Dulaglutide and Potential Risks of Pancreatic Cancer and Thyroid Cancer: A Non-Interventional PASS (H9X-MC-B013)
• DARWIN EU® study:
  No
• Study countries:
  Finland

  Sweden
• Study description:
  This study is a retrospective, non-interventional post-authorization safety study that uses real-world data from two European countries (Sweden and Finland) to evaluate the incidence of pancreatic cancer and thyroid cancer in association with dulaglutide treatment compared to other second-line anti-diabetes medications among patients with T2DM.
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 07/11/2019

Study start date

Planned: 31/01/2022

Actual: 01/06/2024

Date of interim report, if expected

Planned: 31/12/2025

Date of final study report

Planned: 31/12/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly & Co.

Study protocol

Initial protocol

B013 05 Protocol (a)_Redacted

Updated protocol

LY2189265 Dulaglutide B013 (e) NI PASS Protocol _Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)