An Observational Study of the Risk of Malignant Neoplasms and Malignant Neoplasms of Special Interest (Thyroid and Pancreatic Cancer) in Subjects Treated with Albiglutide Compared to Those Treated with Other Antidiabetic Agents (201805)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36771
• EU PAS number:
  EUPAS11850
• Study ID:
  36771
• Official title and acronym:
  An Observational Study of the Risk of Malignant Neoplasms and Malignant Neoplasms of Special Interest (Thyroid and Pancreatic Cancer) in Subjects Treated with Albiglutide Compared to Those Treated with Other Antidiabetic Agents (201805)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  With the cancellation of the Eperzan EU MA in January 2019, this post marketing study is no longer required or feasible to conduct. This study is a nested case control study and uses the Clinical Practice Research Datalink (CPRD) of the U.K. The diabetes cohort will include type 2 diabetic subjects aged ≥ 18 years old who are “new users” of an antidiabetic agent (ADA) as of when albiglutide is fully launched in the UK. The study compares the risk of malignant neoplasms of special interest (thyroid and pancreatic cancer) in subjects prescribed albiglutide, and albiglutide in combination with insulin, to other antidiabetic agent and insulin, respectively. It also compares the risk of the most common malignant neoplams in subjects prescribed albiglutide in combination with insulin compared to insulin. Analysis will be conducted when approximately 10,000 albiglutide prescribed subjects, with a minimum follow-up duration of one year each, have accrued in the database. Conditional logistic regression will be used to estimate odds ratios and 95% confidence intervals (CIs) of the malignant neoplasms of special interest and the common malignant neoplasms associated with the use of albiglutide compared to other antidiabetic agents.
• Study status:
  Finalised

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 27/11/2015

Actual: 18/11/2015

Study start date

Planned: 01/01/2018

Actual: 18/11/2015

Date of final study report

Planned: 27/11/2024

Actual: 10/01/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-201805-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)