A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

Summary

The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed and reported in this study.

Conditions

• Diabetes Mellitus, Type 2
• Cardiovascular Diseases

Interventions

DRUG

Canagliflozin

No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.

DRUG

Empagliflozin

No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.

DRUG

Dapagliflozin

No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.

DRUG

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

No intervention or treatment assignment imposed by this study. Participants received DPP-4 inhibitor as a part of routine clinical practice. DPP-4 inhibitors includes: alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin.

DRUG

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

No intervention or treatment assignment imposed by this study. Participants received GLP-1 agonist as a part of routine clinical practice. GLP-1 agonists includes: albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide.

DRUG

Anti-hyperglycemic Agents (AHA)

No intervention or treatment assignment imposed by this study. Participants received other selected AHA as a part of routine clinical practice. Other select AHAs includes: acarbose, bromocriptine, miglitol, nateglinide, repaglinide.

DRUG

Thiazolidinediones (TZD)

No intervention or treatment assignment imposed by this study. Participants received TZD as a part of routine clinical practice. TZDs includes: pioglitazone, rosiglitazone, troglitazone.

DRUG

Sulfonylureas (SU)

No intervention or treatment assignment imposed by this study. Participants received SU as a part of routine clinical practice. SUs includes: glipizide, glyburide, glimepiride, chlorpropamide, tolazamide, tolbutamide, acetohexamide

DRUG

Insulin

No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

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

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-22

Primary Completion

2018-04-06

Completion

2018-06-25

Countries

• United States

Study Locations