drugset / Trial / NCT00747006

Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake

NCT00747006

Phase 2 Terminated 18 enrolled Mannkind Corporation
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

EvaluationDrugModalityDoseRoute
Subject Insulin Lispro Protein / enzyme biologic Subcutaneous
Subject TI Inhalation Powder Unknown Inhaled