Status: Ongoing First registered on: 09/02/2017
Last updated on: 09/02/2017
1. Study identification
EU PAS Register NumberEUPAS17776
Official titleIncretin‐based drugs and Retinopathy risk in Medicare Enrollees
Study title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDepartment of Epidemiology, University of North Carolina at Chapel Hill
Centre locationChapel Hill, North Carolina, United States
Details of (Primary) lead investigator
Title Dr
Last name Stürmer
First name Til
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/02/201709/02/2017
Start date of data collection09/02/201709/02/2017
Start date of data analysis09/02/201709/02/2017
Date of interim report, if expected
Date of final study report28/02/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherUnfunded100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Stürmer
First name Til
Address line 1135 Dauer Drive, CB# 7435
Address line 2 
Address line 3 
CityChapel Hill, NC 
Postcode27599 
CountryUnited States
Phone number (incl. country code)001-9199667433 
Alternative phone number 
Fax number (incl. country code) 
Email address sturmer@unc.edu
Public Enquiries
Title Dr 
Last name Stürmer 
First name Til 
Address line 1135 Dauer Drive, CB# 7435 
Address line 2 
Address line 3 
CityChapel Hill, NC 
Postcode27599 
CountryUnited States 
Phone number (incl. country code)001-9199667433 
Alternative phone number 
Fax number (incl. country code) 
Email address sturmer@unc.edu 
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