Study identification

PURI

https://redirect.ema.europa.eu/resource/8696

EU PAS number

EUPAS8695

Study ID

8696

Official title and acronym

Study Comparing Risk of Hospitalization for Heart Failure Between Dipeptidyl Peptidase-4 Inhibitors and Sulfonylureas

DARWIN EU® study

No

Study countries

United States

Study description

Primary 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. SUs2. 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 linagliptinStudy designThis 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.

Study status

Ongoing
Research institution and networks

Institutions

AstraZeneca
First published:
01/02/2024
Institution
Truven Health Analytics Bethesda, MD, USA, Georgetown University Medical Center Washington, DC, USA

Contact details

Sheehan Jack

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca
Study protocol
Initial protocol
English (216.25 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No