drugset / Trial / NCT00774800
Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |
| Subject | rHuPH20 | Protein / enzyme biologic | 24 iu | — |