NCT00883558

Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus

A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.

Detailed description

The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus insulin lispro alone.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Insulin Lispro
DRUG	regular human insulin
DRUG	recombinant human hyaluronidase PH20
DRUG	Insulin glargine

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-02-01
• Completion: 2010-04-01
• First posted: 2009-04-17
• Last updated: 2014-09-08
• Results posted: 2014-09-08

Locations

8 sites across 1 country: United States