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A phase III, open-label, monotherapy and combination therapy long-term study of imeglimin (TIMES 2)

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A phase III, open-label, monotherapy and combination therapy long-term study of imeglimin (TIMES 2)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2022

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At a glance

  • Drugs Imeglimin (Primary) ; Alpha-glucosidase inhibitors; Antihyperglycaemics; Biguanides; Dipeptidyl peptidase 4 inhibitors; Glucagon-like peptide 1 agonist; Sodium-glucose transporter 2 inhibitors; Sulfonylureas; Thiazolidinediones
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational
  • Acronyms TIMES 2
  • Sponsors Cmic; Poxel; Sumitomo Dainippon Pharma

    • Most Recent Events

    • 01 Apr 2022 Results assessing the safety and efficacy of imeglimin for 52 weeks as monotherapy or combination therapy with existing antidiabetic agents in Japanese patients with type 2 diabetes published in the Diabetes, Obesity and Metabolism
    • 22 Mar 2022 According to Poxel media release, data from this study were published at Diabetes Obesity and Metabolism in December 2021.
    • 20 May 2021 According to Poxel media release, a new drug application for TWYMEEG Tablets 500mg3 for the treatment of type 2 diabetes, was approved in Japan supported by positive results from the Phase 3 TIMES program

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