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

Part of paid clinical trials in Trevose, Pennsylvania.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03249506
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    Participants who received canagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
  • Empagliflozin — DRUG
    Participants who received empagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
  • Dapagliflozin — DRUG
    Participants who received dapagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
  • Dipeptidyl Peptidase-4 Inhibitor (DPP-4) — DRUG
    Participants who received a DPP-4 as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
  • Glucagon-Like Peptide-1 Agonist (GLP-1) — DRUG
    Participants who received a GLP-1 as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
  • Thiazolidinedione (TZD) — DRUG
    Participants who received a TZD as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
  • Sulfonylureas — DRUG
    Participants who received a sulfonylureas as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
  • Insulin — DRUG
    Participants who received a insulin as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.

Study Details

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 Dates

Start date
May 12, 2016
Status verified
Nov 2017
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017

Study Design

Enrollment
25,358 participants (actual)

Arms

  • Arm: Cohort 1: Non-SGLT2i new Users
    This is a retrospective cohort study identifying participants with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease using the Military Health System (MHS) over a 3-year period. Cohort 1 included participants with incident exposure of one or more non-sodium glucose co-transporter 2 inhibitor (SGLT2i) anti-hyperglycemic agent (AHA) therapy during the study period with no prior or subsequent SGLT2i exposure throughout the study period. New users are defined as participants whose first exposure to any non-metformin AHA medication occurs greater than or equal to (\>=) 365 days after their start of observation in the database with no prior exposure to any medication within the same AHA medication class in the prior 365 days.
  • Arm: Cohort 2: SGLT2i new Users
    Cohort 2 included participants with incident SGLT2i exposure during the study period regardless of prior or concurrent exposure to one or more additional AHA therapy. New users are defined as participants whose first exposure to SGLT2i medication occurs \>= 365 days after their start of observation in the database with no prior exposure to the same AHA medication class in the prior 365 days.

Primary Outcome Measure

Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF) [ Time Frame: approximately 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Health ResearchTx, LLCTrevosePennsylvania19053-

Find similar trials in Trevose, PA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Health ResearchTx, LLC· Trevose, PA

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