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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Thiazolidinedione (TZD); Drug: Glucagon-Like Peptide-1 Agonist (GLP-1); Drug: Canagliflozin; Drug: Dipeptidyl Peptidase-4 Inhibitor (DPP-4); Drug: Insulin; Drug: Sulfonylureas; Drug: Dapagliflozin; Drug: Empagliflozin

Study type: Observational

Funder types: Industry

Identifiers

NCT03249506

RRA-17640 (Other Identifier)

CR108355

Details and patient eligibility

About

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).

Enrollment: 25,358 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25,358 participants in 2 patient groups

Cohort 1: Non-SGLT2i new Users

Description:

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.

Treatment:

Drug: Glucagon-Like Peptide-1 Agonist (GLP-1)

Drug: Insulin

Drug: Thiazolidinedione (TZD)

Drug: Sulfonylureas

Drug: Dipeptidyl Peptidase-4 Inhibitor (DPP-4)

Cohort 2: SGLT2i new Users

Description:

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.

Treatment:

Drug: Dapagliflozin

Drug: Empagliflozin

Drug: Canagliflozin