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

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).

Conditions

• Diabetes Mellitus, Type 2

Interventions

DRUG

Canagliflozin

Participants who received canagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.

DRUG

Empagliflozin

Participants who received empagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.

DRUG

Dapagliflozin

Participants who received dapagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.

DRUG

Dipeptidyl Peptidase-4 Inhibitor (DPP-4)

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.

DRUG

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

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.

DRUG

Thiazolidinedione (TZD)

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.

DRUG

Sulfonylureas

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.

DRUG

Insulin

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.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-12

Primary Completion

2017-11-01

Completion

2017-11-01

Countries

• United States

Study Locations