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

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

Outcome

Met primary endpoint

registry Glulisine Alone vs Glulisine + rHuPH20; p <0.0001; Geometric Least Squares Mean Ratio 2.08 (90% CI 1.70 to 2.55) NCT00979875 ↗

registry Lispro Alone vs Lispro + rHuPH20; p <0.0001; Geometric Least Squares Means Ratio 5.26 (90% CI 3.88 to 7.12) NCT00979875 ↗

registry Aspart Alone vs Aspart + rHuPH20; p <0.0001; Geometric Least Squares Means Ratio 4.14 (90% CI 3.05 to 5.60) NCT00979875 ↗

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.