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An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c

Trial Profile

An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2018

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At a glance

  • Drugs Exenatide (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms FREEDOM-1 HBL
  • Sponsors Intarcia Therapeutics

Most Recent Events

  • 04 Jan 2018 Results assessing efficacy and tolerability of a continuous delivery subcutaneous formulation of exenatide in patients with type 2 diabetes mellitus that is inadequately controlled with diet and exercise alone or in combination with oral antihyperglycaemics with high baseline HbA1c, were published in the Diabetes Care.
  • 19 Oct 2017 Planned primary completion date changed from 1 Aug 2017 to 1 Nov 2017.
  • 16 Sep 2016 Results of procedure experience from this and other three trials of FREEDOM Phase 3 program (n=5200) presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes.

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