NCT01989754

A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,813 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 consists of a 2-week screening period and a double-blind treatment period lasting between 78 and 156 weeks; study completion is targeted for when the last subject randomized has approximately 78 weeks of follow-up or when 688 major adverse cardiovascular events are accumulated between CANVAS and CANVAS-R. A total of 5,700 participants are targeted to be recruited into the study. Participants can be either drug naïve to antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic therapy for the control of blood glucose levels. The completion target was reached in February 2017.

Conditions

• Diabetes Mellitus, Type 2
• Albuminuria

Interventions

Type	Name	Description
DRUG	Placebo	One placebo capsule taken orally (by mouth) once daily for 156 weeks
DRUG	Canagliflozin, 100 mg	One 100 mg capsule taken orally (by mouth) once daily
DRUG	Canagliflozin, 300 mg	One 300 mg capsule taken orally (by mouth) once daily

Timeline

• Start date: 2014-01-16
• Primary completion: 2017-02-23
• Completion: 2017-02-23
• First posted: 2013-11-21
• Last updated: 2018-12-11
• Results posted: 2018-12-11

Locations

342 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hungary, Italy, Malaysia, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Russia, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom