drugset / Trial / NCT02403648

Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

NCT02403648

Phase 1 Completed 15 enrolled Biodel
RandomizedCrossoverQuadruple-blindTreatment

Summary

BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.

Timeline

Start
2014-11
Primary completion
2015-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Glucagon Peptide 1 mg Intramuscular
Comparator Lilly Glucagon Unknown 1 mg Intramuscular
Comparator Novo Glucagon Unknown 1 mg Intramuscular

Indications