drugset / Trial / NCT00747006
Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake
RandomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.
Timeline
- Start
- 2008-09
- Primary completion
- 2011-02
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |
| Subject | TI Inhalation Powder | Unknown | — | Inhaled |