NCT03492580

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

Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Patients With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 714,582 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-02-22
• Primary completion: 2018-04-06
• Completion: 2018-06-25
• First posted: 2018-04-10
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States