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

Study identification

• 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 institutions and networks

Institutions

AstraZeneca

Truven Health Analytics Bethesda, MD, USA, Georgetown University Medical Center Washington, DC, USA

Study timelines

Date when funding contract was signed

Planned:10/12/2014

Actual:10/12/2014

Study start date

Planned:06/01/2015

Actual:06/01/2015

Data analysis start date

Planned:26/02/2015

Date of interim report, if expected

Planned:29/05/2015

Date of final study report

Planned:26/06/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  No