Phase 1Completed
A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1b, Single-Dose, Open-Label, Parallel, Controlled Pharmacology Trial of Inhaled Technosphere®/Insulin in Non-Diabetic Subjects With COPD Versus Matched Non-Diabetic Subjects Without COPD.
- Sponsor
- Mannkind Corporation (Industry)
- Enrolment
- 39 enrolled
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Technosphere®/Insulin
- Ages
- adults, older adults
- Registry
- NCT01021891, EUCTR2007-002818-19
Full record on ClinicalTrials.gov
From the registry
Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up. A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at Visit 2 for both COPD and non COPD subjects.
Primary outcomes
- To evaluate the pharmacokinetic disposition of serum insulin and serum fumaryl diketopiperazine following dosing with 30 U T/I, as measured via Area Under the Curve serum insulin and AUC 0-480 min serum FDKP
History
Last registry update
Registered
Study completion
Primary completion
Started