drugset / Trial / NCT00774800

Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus

NCT00774800

Phase 2 Completed 22 enrolled Halozyme Therapeutics
CrossoverSingle-blindTreatment

Summary

Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA) approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and Humulin-R in order to determine if it improves the absorption of these insulins to more closely mimic the body's natural increase in insulin in response to a meal.

Timeline

Start
2008-10
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Subcutaneous
Subject Insulin Lispro Protein / enzyme biologic Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 24 iu