drugset / Trial / NCT00662857
A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro
RandomizedCrossoverOpen-labelTreatment
Summary
28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).
Timeline
- Start
- 2008-04
- Primary completion
- 2008-11
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | 30 iu | Inhaled |
| Subject | Insulin Lispro | Protein / enzyme biologic | 10 iu | Subcutaneous |