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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492580
• Other study ID #: CR108464
• Secondary ID: RRA-20250
• Status: Completed
• Start date: February 22, 2018
• Est. completion date: June 25, 2018

Study information

• Verified date: August 2018
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714582
• Est. completion date: June 25, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure

Intervention

Drug:
• Canagliflozin
No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.
• Empagliflozin
No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.
• Dapagliflozin
No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.
• 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.
• 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.
• 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.
• 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.
• 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
• Insulin
No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.

Locations

Country	Name	City	State
United States	Janssen Investigative Site	Titusville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Hospitalizations for Heart Failure	Number of hospital admissions with a primary diagnosis of 'heart failure' will be reported.	Approximately 4-years
Primary	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.	Approximately 4-years