Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, albuminuria
Treatments placebo, canagliflozin, 100 mg, canagliflozin, 300 mg
Phase phase 4
Sponsor Janssen Research & Development, LLC
Collaborator The George Institute for Global Health, Australia
Start date January 2014
End date January 2017
Trial size 5840 participants
Trial identifier NCT01989754, 2013-003050-25, 28431754DIA4003, CR102647

Summary

The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 13 weeks, then the dose may be increased to 300 mg once daily.
canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily
canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily
(Placebo Comparator)
Each patient will receive placebo (inactive medication) once daily.
placebo
One placebo capsule taken orally (by mouth) once daily for 156 weeks

Primary Outcomes

Measure
Number of participants with progression of albuminuria
time frame: Baseline, Week 26, 52, 78, 104, 156

Secondary Outcomes

Measure
Composite Endpoint of Death From Cardiovascular (CV) Causes or Hospitalization for Heart Failure
time frame: Baseline, up to April 2017
Death from CV Causes
time frame: Baseline, up to April 2017

Eligibility Criteria

Male or female participants at least 30 years old.

Inclusion Criteria: - Must have a diagnosis of type 2 diabetes mellitus - Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to <=10.5% at screening) - Greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events - Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels. Exclusion Criteria - History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy - History of one or more severe hypoglycemic episode within 6 months before screening - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - Ongoing, inadequately controlled thyroid disorder - Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant - Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.

Additional Information

Official title A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus
Description The study will be conducted in adult participants with Type 2 Diabetes Mellitus (T2DM), receiving standard of care for hyperglycemia and cardiovascular (CV) risk factors, who have either a history of a prior CV event or 2 or more risk factors for a CV event. Participants will be randomly assigned in a 1:1 ratio to canagliflozin or matching placebo to be taken once daily. Canagliflozin will be provided at a dose of 100 mg/day through Week 13 and then increased at the discretion of the investigator to a dose of 300 mg/day, if the participant requires additional glycemic control and is tolerating the 100 mg dose. The study will consist of a 2-week screening period and a double-blind treatment period lasting between 78 and 156 weeks with study completion in April 2017. A total of 5,700 participants will be recruited into the study; the maximum duration of the study for each participant can be up to 3.5 years. Participants can be either drug naïve to antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic therapy for the control of blood glucose levels.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.