Value through Innovation27 July 2016

Clinical Study Results

  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.19
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, parallel group, 52 week study to evaluate efficacy and safety of once daily empagliflozin and linagliptin fixed dose combination compared with linagliptin plus placebo in Japanese type 2 diabetes mellitus patients with insufficient glycaemic control after 16 weeks treatment with once daily linagliptin 5 mg.

    Study Document Lay summary 1275.19 english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.13
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, parallel group, 24-week study to evaluate efficacy and safety of once daily empagliflozin 10 mg and linagliptin 5 mg fixed dose combination compared with empagliflozin 10 mg plus placebo and a 52- week study to evaluate efficacy and safety of once daily empagliflozin 25 mg and linagliptin 5 mg fixed dose combination compared with empagliflozin 25 mg plus placebo (including a 28-week extension period to investigate the longterm safety) in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16-week treatment with empagliflozin (10 mg or 25 mg) alone once daily

    Study Document Lay summary 1275.13 english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.