Effect of Incretin Analogues and Dipeptidyl-peptidase-IV inhibitors on colorectal cancer risk

Study identification

• EU PAS number:
  EUPAS9592
• Study ID:
  13643
• Official title and acronym:
  Effect of Incretin Analogues and Dipeptidyl-peptidase-IV inhibitors on colorectal cancer risk
• 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 2007-2012. The study population consists of Medicare enrollees initiating incretin-based drugs (GLP-1ra or DPP-4i) or other antidiabetic drugs (TZDs, sulfonylureas or long-acting insulins). New users of incretin-based drugs and other antidiabetic drugs will be compared with respect to incidence of colorectal cancer (primary outcome) and incidence of colorectal cancer combined with benign colorectaltumors (secondary outcome) adjusted for baseline information collected prior to drug initiation.
• Study status:
  Finalised

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Gillings School of Public Health

Study timelines

Date when funding contract was signed

Planned:01/04/2015

Actual:01/04/2015

Study start date

Planned:01/04/2015

Actual:01/04/2015

Data analysis start date

Planned:01/04/2015

Actual:01/04/2015

Date of final study report

Planned:29/04/2016

Actual:10/05/2016

Sources of funding

Other

More details on funding

Unfunded

Regulatory

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