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A Randomized, Open-label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

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Trial Profile

A Randomized, Open-label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

Status: Suspended
Phase of Trial: Phase II

Latest Information Update: 11 Apr 2016

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At a glance

  • Drugs Insulin (Primary) ; Insulin neutral protamine lispro/insulin lispro
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Sponsors Biodel

Most Recent Events

  • 09 Apr 2016 Status changed from active, no longer recruiting to suspended, according to ClinicalTrials.gov record.
  • 12 Oct 2015 According to a media release, the U.S. FDA has removed the partial clinical hold for this trial. The correspondence from the FDA clears the use of Biodel's investigational U-400 syringes in the clinical trial.
  • 13 Aug 2015 This study is not currently recruiting new subjects due to a request from the FDA to provide additional data concerning the investigational U-400 syringe used to deliver BIOD-531, according to a Biodel media release.

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