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Type 1 Diabetes MellitusPhase 2NCT02527265

Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

A Phase 2 study testing Afrezza in people with Type 1 Diabetes Mellitus, run by Mannkind Corporation at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 17 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Afrezza
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
13 sitesUnited States
Study dates
28 Sep 2017to 25 Jun 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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;
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  • 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

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Van Meter Pediatric Endocrinology, P.C.

    Atlanta, Georgia, 30318

  • Emory University Children's Center

    Atlanta, Georgia, 30322

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • Barry J. Reiner, MD, LLC

    Baltimore, Maryland, 21229

  • University of Florida

    Gainesville, Florida, 32610

  • Indiana University, Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS)

    Las Vegas, Nevada, 89113

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38105

  • Yale University Hospital

    New Haven, Connecticut, 06510

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • USF Diabetes Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: 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

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.
Read the detailed description

The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.

Being tested
Afrezza
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfrezzaBiological

    Also called Technosphere Insulin

    Pharmaceutical form: powder

    Route of administration: inhalation

Study groups in NCT02527265
Study groupRoleWhat they receive
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.
Receives: Biological: Afrezza

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin Maximum Observed Concentration (Cmax)

    Insulin Cmax after a dose of Afrezza

    Measured: 250 minutes post-dose

Secondary outcomes (3)

  1. Insulin Time to Reach Cmax (Tmax)

    Insulin Tmax after a dose of Afrezza

    Measured: 250 minutes post-dose

  2. Insulin Area Under Concentration Time Curve (AUC)

    Insulin AUC after a dose of Afrezza

    Measured: 250 minutes post-dose

  3. Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2)

    FDKP (inert carrier excipient) calculated half life t1/2

    Measured: Using PK data collected over 250 minutes post-dose of Afrezza

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study start28 Sep 2017
  3. Primary completion17 Mar 2020
  4. Study completion25 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02527265
Sponsor's protocol ID
MKC-TI-155 Part 1
Other IDs
U1111-1166-5528
Status last verified
Mar 2021
First submitted
17 Aug 2015
Last updated
6 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36652106

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Afrezza in people with Type 1 Diabetes Mellitus, run by Mannkind Corporation at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin Maximum Observed Concentration (Cmax) (time frame: 250 minutes post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02527265, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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