Diabetes Mellitus, Type 2 Clinical Trial
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
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.
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.
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