28431754DIA4003 (CANVAS-R)
Research type
Research Study
Full 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
IRAS ID
145868
Contact name
Melanie Davies
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2013-003050-25
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Canagliflozin (JNJ-28431754) is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2) that has been developed as an oral antihyperglycemic agent (AHA) for the treatment of patients with type 2 diabetes mellitus (T2DM). In March 2013, canagliflozin was approved for marketing by the United States (US) Food and Drug
Administration (FDA). An ongoing clinical program designed to continue research on the effects of the agent on renal and cardiovascular outcomes is underway.The purpose of this study is to look at the effects of taking canagliflozin (compared to placebo) on the amount of protein (albuminuria) put out in the urine and the rate at which the kidney filters blood in patients with Type 2 diabetes mellitus (T2DM) whose diabetes is not well treated with standard diabetes therapies. The study is also designed to look at whether canagliflozin is safe and well tolerated in patients with T2DM including effects on the heart and circulatory system.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0065
Date of REC Opinion
12 Mar 2014
REC opinion
Further Information Favourable Opinion