Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)

Completed

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to identify and evaluate the event rate of the composite endpoint of all-cause mortality (ACM) or hospitalization for heart failure (HF) for participants with Type 2 Diabetes mellitus (T2DM) and established cardiovascular (CV) disease among new users of sodium-glucose co-transporter 2 inhibitor (SGLT2i) as compared with new users of non-SGLT2i anti-hyperglycemic agent (AHA).

Key facts

Study ID

NCT03249506

Run by

Janssen Research & Development, LLC

People needed

25358

Starts

2016-05-12

Expected to finish

2017-11-01

Last updated by the study team

2017-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes mellitus (T2DM), defined as: greater than or equal to (>=) 1 anti-hyperglycemic agent (AHA) medication in the study period, and; >=1 diagnosis of T2DM in any available diagnosis field on or prior to index
• Established cardiovascular disease, defined as >=1 diagnosis in any diagnosis field for any of the following conditions: cerebrovascular disease; coronary artery disease (including heart failure [HF]); peripheral artery disease
• >=1-year pre-index continuous eligibility; enrollment gaps of less than or equal to (<=) 30 days will be considered continuous enrollment

You may not qualify if…

• Type 1 Diabetes mellitus (T1DM) diagnosis on or prior to the index date
• Secondary diabetes mellitus (DM) on or prior to the index date
• Missing sex data

Where it is running

• Health ResearchTx, LLC — Trevose, Pennsylvania, United States

Full record on ClinicalTrials.gov

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