drugset / Trial / NCT01201278
PK/PD Study of Intranasal Insulin in Type I Diabetes
Phase 1
Unknown
20 enrolled
Hompesch, Marcus, M.D.
Profil Institute for Clinical Research, Inc. · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This study is designed to compare the safety and tolerability of two different doses of intranasally administered regular human insulin with those of a single dose of the rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated by means of the euglycemic glucose clamp technique.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | 8 iu | Intranasal |
| Subject | Insulin | Protein / enzyme biologic | 16 iu | Intranasal |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 8 iu | Subcutaneous |