drugset / Trial / NCT00883558
Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
RandomizedCrossoverOpen-label
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.
Timeline
- Start
- 2009-05
- Primary completion
- 2010-02
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Lispro | Protein / enzyme biologic | 100 unknown | Subcutaneous |
| Subject | Regular Human Insulin | Protein / enzyme biologic | 100 unknown | Subcutaneous |
| Background | Recombinant human hyaluronidase PH20 | Protein / enzyme biologic | 5 ug/ml | Subcutaneous |
| Background | insulin glargine | Protein / enzyme biologic | 100 unknown | Subcutaneous |