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AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PARALLEL-GROUP CLINICAL TRIAL COMPARING THE EFFICACY AND SAFETY OF MYLAN'S INSULIN GLARGINE WITH LANTUS IN TYPE 1 DIABETES MELLITUS PATIENTS

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AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PARALLEL-GROUP CLINICAL TRIAL COMPARING THE EFFICACY AND SAFETY OF MYLAN'S INSULIN GLARGINE WITH LANTUS IN TYPE 1 DIABETES MELLITUS PATIENTS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Insulin glargine (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms INSTRIDE 1
  • Sponsors Mylan

    • Most Recent Events

    • 11 Jun 2020 According to a Mylan media release, the approval for Semglee was based on a comprehensive analytical, preclinical and clinical program (including the INSTRIDE studies) which confirmed the PK/PD, efficacy, safety and immunogenicity of Semglee in comparison to Lantus in patients with type 1 and type 2 diabetes.
    • 11 Jun 2020 According to a Mylan media release, the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes.
    • 08 Dec 2017 Results from INSTRIDE 1 and INSTRIDE 2 studies assessing safety and efficacy of biosimilar MYL-1501D presented at the 2017 Congress of the International Diabetes Federation

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