Phase I, 4-way crossover trial evaluating the pharmacokinetics, pharmacodynamics and tolerability of BIOD 531 versus Humulin R, U-500 and Humalog prandial/basal premixed insulin in volunteers

Trial Profile

Phase I, 4-way crossover trial evaluating the pharmacokinetics, pharmacodynamics and tolerability of BIOD 531 versus Humulin R, U-500 and Humalog prandial/basal premixed insulin in volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 19 Sep 2014

At a glance

  • Drugs Insulin (Primary) ; Insulin neutral protamine lispro/insulin lispro
  • Indications Insulin resistance; Type 2 diabetes mellitus
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Biodel
  • Most Recent Events

    • 19 Sep 2014 Results presented at the 50th Annual Meeting of the European Association for the Study of Diabetes.
    • 11 Aug 2014 Status changed from recruiting to completed, according to a Biodel media release.
    • 12 Feb 2014 Preliminary results published in Biodel media release.
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