NCT00979875

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

Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic, 6-Way Crossover Study of Subcutaneously Administered Insulin Analogs With Recombinant Human Hyaluronidase (rHuPH20) Compared to Insulin Analogs Alone in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Recombinant human hyaluronidase PH20 (rHuPH20)
DRUG	Insulin lispro
DRUG	Insulin glulisine
DRUG	Insulin aspart

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-02-01
• Completion: 2010-05-01
• First posted: 2009-09-18
• Last updated: 2014-07-14
• Results posted: 2014-07-14

Locations

1 site across 1 country: United States