Status: Ongoing First registered on: 23/02/2015
Last updated on: 23/02/2015
1. Study identification
EU PAS Register NumberEUPAS8695
Official titleStudy Comparing Risk of Hospitalization for Heart Failure Between Dipeptidyl Peptidase-4 Inhibitors and Sulfonylureas
Study title acronym
Study typeObservational study
Brief description of the studyPrimary objective: To compare the risk of hospitalization for heart failure (hHF) between patients with type 2 diabetes mellitus (T2DM) treated with dipeptidyl peptidase-4 inhibitors (DPP-4is) vs. sulfonylureas (SUs) Secondary objectives: 1. To compare the risk of hospitalization for acute myocardial infarction (AMI), hospitalization for stroke, hospitalization for unstable angina, coronary revascularization, and a composite of all aforementioned outcomes including hHF between patients with T2DM treated with DPP-4is vs. SUs 2. To compare the risk of hHF between patients with T2DM treated with saxagliptin vs. sitagliptin or linagliptin 3. To compare the risk of hospitalization for AMI, hospitalization for stroke, hospitalization for unstable angina, coronary revascularization, and a composite of all aforementioned outcomes including hHF between patients with T2DM treated with saxagliptin vs. sitagliptin or linagliptin Study design This will be a retrospective, observational cohort study. This study will use as its methodological foundation, as closely as possible and appropriate, the approach that is outlined in the Mini-Sentinel protocol for active surveillance of AMI in association with use of anti-diabetic agents.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 nameAstraZeneca
Centre location601 Office Center Dr, Suite 200, Fort Washington, PA, 19034
Details of (Primary) lead investigator
Title Dr
Last name Jack
First name Sheehan
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3
Truven Health Analytics, Bethesda, MD, USA
Georgetown University Medical Center, Washington, DC, USA
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 signed10/12/201410/12/2014
Start date of data collection06/01/201506/01/2015
Start date of data analysis26/02/2015
Date of interim report, if expected29/05/2015
Date of final study report26/06/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name John
First name Sheehan
Address line 1601 Office Center Dr
Address line 2Suite 200 
Address line 3 
CityFort Washington 
Postcode 
CountryUnited States
Phone number (incl. country code)12155423369 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name John 
First name Sheehan 
Address line 1601 Office Center Dr 
Address line 2Suite 200 
Address line 3 
CityFort Washington 
Postcode 
CountryUnited States 
Phone number (incl. country code)12155423369 
Alternative phone number 
Fax number (incl. country code) 
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