A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
Twelve Type 2 diabetic subjects will each receive 2 different insulin medicinal products prior to a meal test and then, following an interim safety visit, receive the same 2 doses of insulin in the same order during a glucose clamp procedure.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
- To assess endogenous glucose production (EGP) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Drug: Technosphere Insulin
This is a randomized, open label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit. Each treatment visit, meal challenge and glucose clamp, will have the subjects hospitalized in the clinical unit the night before initiation of treatment.