A Phase 2, Open-Label, Randomized, 2-Way Crossover, Clinical Trial to Compare the Pharmacokinetics of 2 Formulations of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder and to Determine the Bioavailability of a 30 Unit Cartridge of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder Versus a 10 Unit Subcutaneous Injection of Insulin Lispro in Subjects With Type 1 Diabetes Mellitus

NCT00662857 Phase 2 COMPLETED Results posted

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).

Details

Lead sponsor	Mannkind Corporation
Phase	Phase 2
Status	COMPLETED
Enrolment	29
Start date	2008-04
Completion	2008-12

Conditions

• Diabetes Mellitus: Type 1

Interventions

• Technosphere® Insulin Inhalation Powder
• Technosphere Insulin® Inhalation Powder
• RAA Population

Primary outcomes

• Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360 — 0 to 360 minutes post-dose
  Dose-normalized baseline-corrected area under the serum insulin vs. time curve
• Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax. — 0 to 360 minutes post-dose
  Maximum observed baseline-corrected serum insulin concentration
• Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax — 0 to 360 minutes post-dose
• Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro — 0 to 360 minutes post-dose
  Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)

Countries

United States