Status:
COMPLETED
Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
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 Diabe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 12 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
25358 Patients enrolled
Trial Details
Trial ID
NCT03249506
Start Date
May 12 2016
End Date
November 1 2017
Last Update
November 21 2017
Active Locations (1)
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1
Health ResearchTx, LLC
Trevose, Pennsylvania, United States, 19053