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A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes.

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Trial Profile

A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Exenatide (Primary) ; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms FREEDOM-2
  • Sponsors Intarcia Therapeutics

    • Most Recent Events

    • 15 Sep 2017 Results of an exploratory analysis assessing the need for further diabetes therapy in addition to ITCA 650 exenatide or sitagliptin, presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes
    • 15 Sep 2017 Results of pooled analysis from FREEDOM-1 and FREEDOM-2 trials were presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes
    • 13 Jun 2017 Results (n=530) of an exploratory analysis of this trial assessing the need for further therapy in addition to ITCA 650 or sitagliptin added to metformin in uncontrolled type 2 diabetes mellitus patients, presented at the 77th Annual Scientific Sessions of the American Diabetes Association.
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