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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2017

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

    • 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.
    • 13 Jun 2017 Results of a pooled analysis from FREEDOM-1 and FREEDOM-2 trials presented at the 77th Annual Scientific Sessions of the American Diabetes Association
    • 10 Jun 2017 Biomarkers information updated
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