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A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy

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Trial Profile

A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2022

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At a glance

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

    • 13 Jun 2017 Results assessing HbA1c in the 16-week Open-label Linagliptin period (n=564), presented at the 77th Annual Scientific Sessions of the American Diabetes Association
    • 13 Jun 2017 Results presented at the 77th Annual Scientific Sessions of the American Diabetes Association
    • 02 Dec 2016 Primary endpoint (HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment) has been met, according to results published in the Diabetes Care journal.
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