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
Phase of Trial: Phase IV
Latest Information Update: 02 Aug 2018
At a glance
- Drugs Canagliflozin (Primary)
- Indications Cardiovascular disorders; Type 2 diabetes mellitus
- Focus Pharmacodynamics
- Acronyms CANVAS-R
- Sponsors Janssen Research & Development
- 02 Aug 2018 Based on the results of CANVAS Program, the CHMP, adopted a positive opinion to update the INVOKANA (canagliflozin) and VOKANAMET (canagliflozin and metformin) labelling including changes to the indication statement for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. The new recommended product information will include data on the reduction in major adverse cardiovascular events in patients with type 2 diabetes mellitus.
- 13 Jul 2018 According to the Janssen media release, the company announce that the US FDA has extended the review timeline for a sNDA for INVOKANA. After extension, the action date is now in October 2018.
- 26 Jun 2018 Results assessing the effect of canagliflozin on CV, mortality and renal outcomes by baseline HbA1c, presented at the 78th Annual Scientific Sessions of the American Diabetes Association.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History