A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone

Phase 1 Completed 14 enrolled Halozyme Therapeutics

RandomizedCrossoverDouble-blind

Summary

This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.

Timeline

Start: 2009-09
Primary completion: 2010-02
Completion: 2010-05

Publications

Morrow L, Muchmore DB, Hompesch M, Ludington EA, Vaughn DE. Comparative pharmacokinetics and insulin action for three rapid-acting insulin analogs injected subcutaneously with and without hyaluronidase. Diabetes Care. 2013 Feb;36(2):273-5. doi: 10.2337/dc12-0808. Epub 2012 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin Lispro	Protein / enzyme biologic	0.15 iu/kg	Subcutaneous
Subject	Insulin glulisine	Protein / enzyme biologic	0.15 iu/kg	Subcutaneous
Subject	insulin aspart	Protein / enzyme biologic	0.15 iu/kg	Subcutaneous
Subject	rHuPH20	Protein / enzyme biologic	5 ug/ml	Subcutaneous

Indications

No indication recorded.