Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
Open-label, Single-arm, Multiple-dose Safety, Titration, and Pharmacokinetic Trial of Afrezza® in Pediatric Patients Ages 4 to 17 Years With Type 1 Diabetes Mellitus
2 other identifiers
interventional
30
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2017
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedStudy Start
First participant enrolled
September 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2020
CompletedResults Posted
Study results publicly available
April 6, 2021
CompletedApril 6, 2021
March 1, 2021
2.5 years
August 17, 2015
February 5, 2021
March 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Insulin Maximum Observed Concentration (Cmax)
Insulin Cmax after a dose of Afrezza
250 minutes post-dose
Secondary Outcomes (3)
Insulin Time to Reach Cmax (Tmax)
250 minutes post-dose
Insulin Area Under Concentration Time Curve (AUC)
250 minutes post-dose
Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2)
Using PK data collected over 250 minutes post-dose of Afrezza
Study Arms (1)
Afrezza (Technosphere Insulin)
EXPERIMENTALIndividualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days. During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day.
Interventions
Pharmaceutical form: powder Route of administration: inhalation
Eligibility Criteria
You may qualify if:
- 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 \<10.0% at the time of screening;
- Fasting serum C-peptide ≤0.3 ng/mL;
- Forced expiratory volume in 1 second (FEV1) ≥70% of 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 ≥70% of NHANES III predicted for children ≥8 years of age or Wang predicted for children \<8 years of age;
- Females of childbearing potential, must use "highly effective" methods of contraception throughout conduct of the trial
You may not qualify if:
- Body mass index below 25th or above 95th percentile for age and gender according to Centers for Disease Control and Prevention 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;
- 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 (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;
- 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; subject may return 4 weeks after resolution of the infection for rescreening;
- 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;
- Smoking of tobacco or other substances or positive urine cotinine testing (\>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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Yale University Hospital
New Haven, Connecticut, 06510, United States
University of Florida
Gainesville, Florida, 32610, United States
USF Diabetes Center
Tampa, Florida, 33612, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Van Meter Pediatric Endocrinology, P.C.
Atlanta, Georgia, 30318, United States
Emory University Children's Center
Atlanta, Georgia, 30322, United States
Indiana University, Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Barry J. Reiner, MD, LLC
Baltimore, Maryland, 21229, United States
Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS)
Las Vegas, Nevada, 89113, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105, United States
Related Publications (1)
Haller MJ, Jones MC, Bhavsar S, Kaiserman KB. Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes. Diabetes Ther. 2023 Mar;14(3):611-617. doi: 10.1007/s13300-023-01368-7. Epub 2023 Jan 18.
PMID: 36652106DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development
- Organization
- MannKind Corporation
Study Officials
- STUDY DIRECTOR
Clinical Operations
Mannkind Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2015
First Posted
August 18, 2015
Study Start
September 28, 2017
Primary Completion
March 17, 2020
Study Completion
June 25, 2020
Last Updated
April 6, 2021
Results First Posted
April 6, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share