Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy
The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).
This is a randomized (the study medication is assigned by chance), double-blind (neither
physician nor participant knows the identity of the assigned treatment), placebo-controlled
(an inactive substance that is compared with a medication to test whether the medication has
a real effect), parallel-group, multicenter study of the effects of canagliflozin on renal
and cardiovascular outcomes in participants with type 2 diabetes mellitus (T2DM) and diabetic
nephropathy, who are receiving standard of care including a maximum tolerated daily dose of
an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).
The study will consist of a pretreatment phase (several weeks), and a double-blind treatment
phase (up to approximately 66 months). During the pretreatment phase all participants will
also receive diet/exercise counseling for lipid and blood pressure management as well as
counseling on renal and cardiovascular (CV) risk factor medication. A post-treatment
follow-up contact or visit will take place approximately 30 days after the last dose of study
drug or the completion of the study. The total duration of the study is estimated to be about
5 to 5.5 years. Approximately 4,200 participants will be randomized in a 1:1 ratio to
canagliflozin or matching placebo. Participants randomized to canagliflozin will receive a
dose of 100 mg once daily. The overall safety and tolerability of canagliflozin will be
evaluated by collecting information on adverse events, laboratory tests, vital signs (pulse,
blood pressure), physical examination, and body weight.
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