Conditions: Diabetes Mellitus: Type 1
Keywords: Diabetic adult male, diabetic adult female
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 29
Healthy volunteers: no

Brief 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).

Detailed description:
28 eligible subjects were planned to be enrolled to determine bioequivalence and safety parameters of two 15 U TI Inhalation Powder cartridges versus one 30 U TI Inhalation Powder cartridge, according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30 U TI Inhalation Powder cartridge to a single subcutaneous injection of 10 IU of RAA will be compared.

Arms:
arm 1: Technosphere® Insulin Inhalation Powder, two 15 U cartridges arm 2: Technosphere® Insulin Inhalation Powder, one 30 U cartridge arm 3: Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro

Interventions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Technosphere Insulin® Inhalation Powder intervention 3: RAA Population
Intervention descriptions: intervention 1: TI Inhalation Powder, two 15 U cartridges intervention 2: TI Inhalation Powder, one 30 U cartridge intervention 3: RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.

Protocol document: