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

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

Outcome

Met primary endpoint

registry Humalog + rHuPH20 vs Humalog Alone; p = 0.0011; Geometric Least Squares Means Ratio 1.54 NCT00774800 ↗

registry Humulin-R + rHuPH20 vs Humulin-R Alone; p <0.0001; Geometric Least Squares Means Ratio 3.06 NCT00774800 ↗

release “The study met the primary endpoint, showing that the Analog-PH20 formulations were non-inferior for A1C, compared to lispro alone (0.4% margin)” halozyme.com ↗

Publications

• Results Hompesch M, Muchmore DB, Morrow L, Vaughn DE. Accelerated insulin pharmacokinetics and improved postprandial glycemic control in patients with type 1 diabetes after coadministration of prandial insulins with hyaluronidase. Diabetes Care. 2011 Mar;34(3):666-8. doi: 10.2337/dc10-1892. Epub 2011 Jan 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin Lispro	Protein / enzyme biologic	—	Subcutaneous
Subject	Recombinant human hyaluronidase PH20	Protein / enzyme biologic	24 iu	—
Subject	regular insulin	Protein / enzyme biologic	—	Subcutaneous

Indications