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
Phase of Trial: Phase II
Latest Information Update: 11 Apr 2016
At a glance
- Drugs Insulin (Primary) ; Insulin neutral protamine lispro/insulin lispro
- Indications Type 2 diabetes mellitus
- Focus Therapeutic Use
- Sponsors Biodel
- 07 Jun 2017 Biomarkers information updated
- 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.