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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:11/23/2017
Start Date:May 12, 2016
End Date:November 1, 2017

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Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus

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).


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
Trevose, Pennsylvania 19053
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Trevose, PA
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