Healthy
Conditions
Keywords
Healthy Patients
Brief summary
A prospective, single center, open randomized, six way crossover study comparing the dose response effect of four different doses of Technosphere Insulin after pulmonary function delivery in comparison to s.c. injection of two different doses of regular human insulin.
Interventions
Sponsors
Mannkind Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be in good health, as judge by brief history and physical examination. * Sex: both, male and female. * Age: 18-40 years. * Body mass index: 18-27 kg/m2. * Capability to reach peak inspiratory flow of \>41/sec measured by a computer assisted spirometry. * FEV1 equal to or greater than 80% of predicted normal.
Exclusion criteria
* Diabetes Mellitus type 1 or type 2. * Human insulin antibodies. * Anamnestic history of hypersensitivity to the study medication or to drugs with similar chemical structures. * Having a history of severe or multiple allergies. * Treatment with any other investigational drug in the last three months before study entry. * Progressive fatal disease. * History of significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and /or hematological disease. * Having ongoing respiratory tract infection. * Smoker defined as subjects with evidence or history of tobacco or nicotine use in the last year prior to entry in the study. * Blood donation within the last 30 days. * A woman who is lactating. * Pregnant women or women intending to become pregnant during the study. * A sexually active woman of childbearing age not actively practicing birth control or using medically accepted device or therapy. * A lack of compliance or other reasons, which prevent to the opinion of the investigator the participation of the subject in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-corrected area-under-the serum insulin concentration vs. time curve for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment | crossover every 3-28 days for up to 20 weeks |
| Area under the glucose infusion rate for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment | crossover every 3-28 days for up to 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, vital signs, physical examinations, and diabetes-specific signs (ie, hypoglycemia) | crossover every 3-28 days for up to 20 weeks |
Outcome results
None listed