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A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combination Therapy in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

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Trial Profile

A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combination Therapy in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Canagliflozin (Primary) ; Canagliflozin/metformin (Primary) ; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 01 Dec 2016 Pooled analysis of 7 studies including this one and results of substudy of the CANVAS trial (n=432) were published in the Diabetes Therapy.
    • 20 Jul 2016 According to a Janssen media release, INVOKAMET has been approved in Canada for the treatment of adults with type 2 diabetes. Data from this trial supported the approval.
    • 24 May 2016 According to a Janssen media release, the US FDA has approved INVOKAMET, a fixed-dose combination therapy of INVOKANA (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes. With this new approval, INVOKAMET may now be prescribed in adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy. The results from this trial support the approval for the expanded indication.
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