A phase III, double-blind, insulin-combination therapy study of imeglimin (TIMES 3)

Trial Profile

A phase III, double-blind, insulin-combination therapy study of imeglimin (TIMES 3)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2018

At a glance

  • Drugs Imeglimin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms TIMES 3
  • Sponsors Poxel; Sumitomo Dainippon Pharma
  • Most Recent Events

    • 22 Mar 2018 According to Poxel media release, data readout is expected in 2019 and submission of Japanese new drug application in 2020.
    • 13 Mar 2018 Status changed from planning to recruiting, as reported in a Poxel media release.
    • 30 Oct 2017 According to a Sumitomo Dainippon Pharma media release, this trial is a part of the phase III program in Japan that includes 3 pivotal studies with approximately 1100 patients that will support regulatory submissions to the Pharmaceuticals and Medical Devices Agency (PMDA). This trial is expected to be initiated by the end of 2017.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top