A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy

Trial Profile

A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2017

At a glance

  • Drugs Empagliflozin/linagliptin (Primary) ; Empagliflozin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals; Unilfarma
  • Most Recent Events

    • 13 Jun 2017 Results of a pooled analysis from two Phase III trials presented at the 77th Annual Scientific Sessions of the American Diabetes Association
    • 10 Jun 2017 Biomarkers information updated
    • 22 Nov 2016 According to a Boehringer Ingelheim media release, the European Commission has granted marketing authorization to Glyxambi (empagliflozin/linagliptin) for use in adults with type 2 diabetes (T2D). The approval is based on results from this and other two phase III trials (see profile 700205423 and 700226645).
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