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A Multi-centric, Prospective, Randomized, Double- blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 / 4 mg as Compared to Pioglitazone in Type 2 Diabetes Mellitus

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Trial Profile

A Multi-centric, Prospective, Randomized, Double- blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 / 4 mg as Compared to Pioglitazone in Type 2 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Mar 2020

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At a glance

  • Drugs Saroglitazar (Primary) ; Pioglitazone
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms PRESS XII
  • Sponsors Cadila Healthcare

    • Most Recent Events

    • 03 Feb 2020 According to a Zydus Cadila media release, the company has received the approval from the Drug Controller General of India for use of Saroglitazar Mg in the treatment of Type II Diabetes Mellitus as an add on therapy with Metformin.
    • 03 Feb 2020 Results presented in a Zydus Cadila media release.
    • 02 Aug 2019 Primary endpoint (Change from baseline in glycosylated hemoglobin (HbA1c) for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg) has been met, according to a Zydus Cadila media release.

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