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A phase 4, monocenter, randomized, double-blind, comparator-controlled, 3-armed parallel mechanistic intervention trial to assess the effect of 8-week empagliflozin (SGLT-2 inhibitor) monotherapy, followed by 8-week empagliflozin and linagliptin (DPP-4 inhibitor) combination therapy versus 8-week linagliptin monotherapy, followed by 8-week linagliptin and empagliflozin combination therapy versus 8-week gliclazide (Sulfonylurea derivate), followed by 8-week gliclazide intensification therapy on renal physiology and biomarkers in metformin-treated patients with type 2 diabetes mellitus

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Trial Profile

A phase 4, monocenter, randomized, double-blind, comparator-controlled, 3-armed parallel mechanistic intervention trial to assess the effect of 8-week empagliflozin (SGLT-2 inhibitor) monotherapy, followed by 8-week empagliflozin and linagliptin (DPP-4 inhibitor) combination therapy versus 8-week linagliptin monotherapy, followed by 8-week linagliptin and empagliflozin combination therapy versus 8-week gliclazide (Sulfonylurea derivate), followed by 8-week gliclazide intensification therapy on renal physiology and biomarkers in metformin-treated patients with type 2 diabetes mellitus

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 04 Jan 2024

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At a glance

  • Drugs Empagliflozin (Primary) ; Linagliptin (Primary) ; Gliclazide
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacodynamics
  • Acronyms RACELINES

    • Most Recent Events

    • 13 Feb 2022 Status changed from active, no longer recruiting to completed.
    • 13 Jan 2022 Planned End Date changed from 1 Dec 2021 to 1 Sep 2022.
    • 13 Jan 2022 Status changed from recruiting to active, no longer recruiting.

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