Phase 2
Completed N=30
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
Source: ClinicalTrials.gov NCT02527265 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Apr 2021
Primary outcomePrimary: Insulin Maximum Observed Concentration (Cmax) — 28.5; 102; 101; 133 μU/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Maximum Observed Concentration (Cmax) |
28.5; 102; 101; 133; 201; 251 | — |
| SECONDARY Insulin Time to Reach Cmax (Tmax) |
12.5; 9.5; 13.5; 14.1; 15.3; 10.0 | — |
| SECONDARY Insulin Area Under Concentration Time Curve (AUC) |
1468; 2931; 4488; 4975; 6400; 5971 | — |
| SECONDARY Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2) |
103; 86.8; 123; 86.5; 109; 95.5 | — |
Eligibility Criteria
Inclusion criteria
- Written or oral assent from the pediatric subject and written informed consent from the parent(s) or legal guardian and a witness, as required by both state and federal laws and the local Institutional Review Board;
- Children aged ≥4 and ≤17 years (enrolled sequentially into 3 age cohorts: 13 to 17, 8 to 12, and 4 to 7 years);
- Clinical diagnosis of T1DM and using insulin for at least 1 year;
- Currently receiving a regimen of basal/bolus insulin administered by MDI for at least 6 weeks prior to enrollment;
- Subjects with pre-breakfast self monitored blood glucose values between 80 and 250 mg/dL for 5 of 7 documented daily readings obtained in the week prior to Visit 2 (readings to be taken using glucometer provided at Screening Visit 1) and reported via the e Diary;
- Subjects on a regimen of insulin via continuous SC insulin infusion may be enrolled if they satisfy all other enrollment criteria and are willing to convert to MDI for the duration of the study, beginning 6 weeks prior to enrollment. They must continue to meet all enrollment criteria after converting to the MDI regimen;
- Total daily insulin dose ≤1.5 units/kg/day with a minimum of 3 units of RAA at every meal.
- Hemoglobin A1c (HbA1c) ≥7.0% to 100 ng/mL);
- Positive urine drug screen;
- Positive urine pregnancy test for female subjects of childbearing potential;
- Inability to perform study procedures including pulmonary function testing;
- Exposure to any investigational product(s) in the past 3 months or 5 half-lives, whichever is more;
- 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 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.
Data sourced from ClinicalTrials.gov (NCT02527265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.