NCT02485327

PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Technosphere Insulin SAR439065 Afrezza®	Pharmaceutical form: dry powder Route of administration: oral inhalation

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-06-30
• Last updated: 2017-03-15

Locations

1 site across 1 country: Germany