Incretin-based therapies and Pancreatic Cancer risk in Medicare enrollees – new user protocol

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/8912
• EU PAS number:
  EUPAS3255
• Study ID:
  8912
• Official title and acronym:
  Incretin-based therapies and Pancreatic Cancer risk in Medicare enrollees – new user protocol
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This will be a retrospective cohort study using a new-user active comparator design on Medicare Part A, B and D claims data from 2006-2010. The study population consists of Medicare enrollees initiating Incretin-based drugs (IBRx) or other antidiabetic drugs (CompRx). Newusers of IBRx and CompRx will be compared with respect to incidence of pancreatic cancer (primary outcome) and incidence of mortality due to pancreatic cancer (secondary outcome) adjusted for baseline information collected prior to drug initiation. Given the FDA signal about increased pancreatic cancer reporting with IBRx, it is possible that IBRx new-users are subjected to increased screening and there is increased/earlier detection of pancreatic cancer in the IBRx group compared to the CompRx group. We will therefore evaluate and quantify the use of diagnostic procedures that may lead to a preclinical diagnosis of pancreatic cancer among new users of IBRx and CompRx in the 6 month period before and after the start of drug therapy.
• Study status:
  Finalised

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Department of Epidemiology

Study timelines

Date when funding contract was signed

Actual: 10/08/2012

Study start date

Planned: 24/12/2012

Actual: 24/12/2012

Data analysis start date

Planned: 24/12/2012

Actual: 24/12/2012

Date of final study report

Planned: 20/12/2013

Actual: 10/09/2014

Sources of funding

Other

More details on funding

University of North Carolina Chapel Hill Clinical and Translational Science Awards (UNC-CTSA)

Study protocol

Initial protocol

Incretin_PC_protocol 20DEC2012

Regulatory

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