Type 1 Diabetes Mellitus Clinical Trial
Official title:
An Open-label, 2 Replicate Single Dose Euglycemic Glucose-Clamp Trial to Characterize PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)
Primary Objective:
To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to
insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM
patients in a euglycemic clamp setting.
To characterize the within-subject variability in the metabolic activity (pharmacodynamic
[PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic
clamp setting.
Secondary Objectives:
To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a
euglycemic clamp setting.
To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a
euglycemic clamp setting.
To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a
euglycemic clamp setting.
The maximum study duration per patient is approximately 9 weeks (screening of 3 to 28 Days, treatment period of 2 days [Periods 1 and 2], washout period of 5 to 19 days [between treatment period], and end-of-study visit of 7 to 14 days after study drug administration in Period 2). ;
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