Incretin‐based drugs and Retinopathy risk in Medicare Enrollees

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17777
• EU PAS number:
  EUPAS17776
• Study ID:
  17777
• Official title and acronym:
  Incretin‐based drugs and Retinopathy risk in Medicare Enrollees
• 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 2006-2014. The study population consists of Medicare enrollees initiating incretin-based drugs (GLP-1 receptor agonists or DPP-4 inhibitors) or other antidiabetic drugs (thiazolidinediones, sulfonylureas or long-acting insulins). New users of incretin-based drugs and other antidiabetic drugs will be compared with respect to the incidence of retinopathy, adjusted for baseline information collected prior to drug initiation.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Department of Epidemiology

Study timelines

Date when funding contract was signed

Planned: 09/02/2017

Actual: 09/02/2017

Study start date

Planned: 09/02/2017

Actual: 09/02/2017

Data analysis start date

Planned: 09/02/2017

Actual: 09/02/2017

Date of final study report

Planned: 28/02/2018

Sources of funding

Other

More details on funding

Unfunded

Study protocol

Initial protocol

RetinopathyProtocol 08FEB2017

Regulatory

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