Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

Exclusion Criteria

• •1. Body mass index below 25th or above 95th percentile for age and gender according to Centers for Disease Control and Prevention growth charts;
• •2. History of physician diagnosis of asthma or any other clinically important pulmonary disease, or use of any medications to treat such conditions within the last year;
• •3. Allergy or known hypersensitivity for AFREZZA or to drugs with similar chemical structure;
• •4. Unstable diabetes control, defined as 2 or more episodes of severe hypoglycemia (i.e., an episode associated with a seizure, coma, or loss of consciousness) or any hospitalization or emergency room visit for poor diabetes control, ketoacidosis, hypoglycemia, or hyperglycemia within the preceding 3 months from screening;
• •5. Serum creatinine ≥ the upper limit of normal for age;
• •6. Respiratory tract infection within 30 days before screening or between screening and initiation of treatment period; subject may return 4 weeks after resolution of the infection for rescreening;
• •7. Evidence of any complication of diabetes (proliferative retinopathy, autonomic neuropathy, nephropathy, etc), or likelihood of requiring laser photocoagulation, vitrectomy, or other specific treatment for diabetic retinopathy in the coming year;
• •8. Smoking of tobacco or other substances or positive urine cotinine testing (\>100 ng/mL);
• •9. Positive urine drug screen;
• •10. Positive urine pregnancy test for female subjects of childbearing potential;
• •11. Inability to perform study procedures including pulmonary function testing;
• •12. Exposure to any investigational product(s) in the past 3 months or 5 half-lives, whichever is more;
• •13. History of eating disorder;
• •14. Any disease or exposure to any medication which, in the judgment of the principal Investigator, may impact glucose metabolism;
• •15. Any concurrent medical or major psychiatric condition that makes the subject unsuitable for the clinical study or impairs the subject's ability to participate in the study.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.