This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.
Subjects with Type 1 diabetes will be randomized to either one dose of TI inhaled using the Gen2C device, or one dose of subcutaneously injected Rapid Acting Analog (RAA) and crossed over. Crossover Sequences: Sequence #1: Period 1 - one 20 U cartridge of TI; Period 2 - 8 U of RAA Sequence #2: Period 1 - 8 U RAA; Period 2 - one 20 U cartridge of TI An euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to characterize the pharmacokinetics (PK) of the one dose of TI Inhalation Powder using the Gen2C inhaler as compared to one dose of subcutaneous RAA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
17
Inhalation Powder using the Gen2C inhaler
Subcutaneous Injection
Profil Institute for Clinical Research
Chula Vista, California, United States
PK measures for TI Inhalation Powder (20U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing
Time frame: Crossover 1 time within 3 - 10 days
PK measures for RAA (8U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing
Time frame: Crossover 1 time within 3 - 10 days
Safety variables including adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Time frame: Crossover 1 time within 3 - 10 days
Area under serum glucose infusion rate (GIR AUC 0-360) for TI Inhalation Powder (20U) as measured by: GIR AUC 0-360 timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing
Time frame: Crossover 1 time within 3 - 10 days
Area under serum glucose infusion rate (GIR AUC 0-360) for RAA (8U) as measured by: GIR AUC 0-360 timepoints: 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing
Time frame: Crossover 1 time within 3 - 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.