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

Janssen Research & Development, LLC714,582 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

714,582

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases

Interventions

CanagliflozinDRUG

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

Dipeptidyl Peptidase-4 (DPP-4) InhibitorsDRUG

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.

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

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.

Anti-hyperglycemic Agents (AHA)DRUG

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.

Thiazolidinediones (TZD)DRUG

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

Sulfonylureas (SU)DRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * First exposure to the particular drug(s) in database (index date) * Exposure start is between 1 April 2013 and 15 May 2017 * At least 365 days of continuous observation time prior to index * At least 1 condition occurrence of 'Type II diabetes' any time in the prior continuous observation time (which is at least 365 days long) before or on the index date (first exposure to the particular drug(s) in database) For cohort with 'established cardiovascular disease - At least 1 occurrence of 'conditions indicating established cardiovascular disease' on or any time in the prior continuous observation time (which is at least 365 days long) prior to the index date Exclusion Criteria: \- Participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study

Outcomes

Primary Outcomes

Number of Hospitalizations for Heart Failure

Number of hospital admissions with a primary diagnosis of 'heart failure' will be reported.

Time frame: Approximately 4-years

Number of Participants with Below Knee Lower Extremity Amputation Events

Number of participants with new below-knee lower extremity amputation procedures, excluding recent (within 30 day) revisions will be reported.