Clinical trial NCT03249506: Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)
Official title: Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 25358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease using the military health system (MHS) over a 3-year period (4/01/2013 to 3/31/2016) will be observed for the cardiovascular outcomes.

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 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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF)
timeFrame: approximately 3 years
Secondary outcomes:
measure: Incidence Rate of All-Cause Mortality
timeFrame: approximately 3 years
measure: Incidence Rate of Hospitalization for HF
timeFrame: approximately 3 years
measure: Incidence Rate of Major Adverse Cardiovascular Events (MACE)
timeFrame: approximately 3 years
measure: Incidence Rate of Composite of MACE or Hospitalization for HF
timeFrame: approximately 3 years
measure: Incidence Rate of Non-fatal stroke
timeFrame: approximately 3 years
measure: Incidence Rate of Non-Fatal Myocardial Infarction
timeFrame: approximately 3 years
measure: Percentage of Participants With Below Knee Lower Extremity (BKLE) Amputation
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Trevose
country: United States
facility: Health ResearchTx, LLC
state: Pennsylvania
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: