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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top