A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

Trial Profile

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2018

At a glance

  • Drugs Canagliflozin (Primary)
  • Indications Cardiovascular disorders; Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms CANVAS
  • 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.
    • 18 Jul 2018 Brazil, Philippines, Scotland were the planned locations.
    • 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.
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