Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

• Status: Suspended
• Trial end date: 0000-00-00
• Target enrollment: 2
• Participant gender: Both

Summary

Primary Objective:

-To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM).

Secondary Objectives:

• To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal.

• To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin, Globin Zinc
• Last Updated: 2016-03-14

Criteria

Inclusion criteria :

• Children and adolescents ≥4 and ≤17 years.

• Clinical diagnosis of T1DM and using insulin for at least 1 year.

• On a regimen of stable total daily dose (±10%) of basal insulin administered once daily in the evening.

• Currently receiving a stable regimen of basal/bolus insulin administered by multiple daily injections (MDI) for at least 6 weeks prior to inclusion.

• Patient on a stable regimen of insulin via continuous subcutaneous insulin infusion (CSII) may be enrolled if they satisfy all other enrollment criteria and are willing to convert to MDI for the duration of the trial; they must have maintained a stable MDI dose for 6 weeks prior to inclusion with prebreakfast self-monitored plasma glucose (SMPG) values 80 to 250 mg/dL (4.4 to 13.9 mmol/L) for 5 of 7 readings in the previous week before inclusion.

• Total daily insulin dose ≤1.5 IU/kg/day with minimum of 3 IU of rapid-acting insulin analog (RAA) at every meal and maximum of 12 IU of RAA at breakfast.

• Glycated hemoglobin (HbA1c) 7.0% to 10.0% at the time of screening.

• Prebreakfast SMPG values 80 to 250 mg/dL (4.4 to 13.9 mmol/L) for 5 of 7 readings in the previous week.

• Fasting serum C-peptide ≤0.3 ng/mL.

Exclusion criteria:

• Body mass index (BMI) below 25th or above 95th percentile for age and gender according to the Centers for Disease Control and Prevention (CDC) growth charts.

• 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.

• Forced expiratory volume in 1 second (FEV1) <70% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted for children ≥8 years of age or Wang predicted for children <8 years of age.

• Forced vital capacity (FVC) <70% of NHANES III predicted for children ≥8 years of age or Wang predicted for children <8 years of age.

• Allergy or known hypersensitivity for Afrezza or to drugs with similar chemical structure.

• Unstable diabetes control, defined as 2 or more episodes of severe hypoglycemia (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.

• Serum creatinine ≥ the upper limit of normal for age.

• Respiratory tract infection within 30 days before screening or between screening and initiation of treatment period. (Patient may return 4 weeks after resolution of the infection for rescreening.)

• Evidence of any complication of diabetes (proliferative retinopathy, autonomic neuropathy, nephropathy, etc), or the probable need for laser photocoagulation, vitrectomy, or other specific treatment for diabetic retinopathy in the coming year.

• Smoking of tobacco or other substances or positive urine cotinine testing (>100 ng/mL).

• Positive urine drug screen.

• Positive urine pregnancy test for female patients of childbearing potential.

• Inability to perform study procedures including pulmonary function testing.

• Exposure to any investigational product(s) in the past 3 months.

• History of eating disorder.

• Any disease or exposure to any medication, which, in the judgment of the principal Investigator, may impact glucose metabolism.

• Any concurrent medical or major psychiatric condition that makes the patient unsuitable for the clinical study or impairs the patient's ability to participate in the study.

• Patients who refuse to follow the continuous glucose monitoring (CGM) guidelines.

• Patients who take acetaminophen containing medications on a regular basis or anticipated to take during the study period and are unable and/or unwilling to substitute with a non-acetaminophen containing medication.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.