Print

Purpose

INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to <18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent/legally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.

Condition

Eligibility

Eligible Ages
Between 10 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 10 to <18 years of age - Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria - Able to start the Afrezza-BI regimen within 10 days following T1D diagnosis (day 1 is based on the first insulin injection) if not hospitalized with diabetic ketoacidosis (DKA) and within 10 days of hospital discharge if hospitalized with DKA - Forced Expiratory Volume in One Second (FEV1) >80.0% of predicted Global Lung Function Initiative (GLI) value - Investigator believes that participant can be expected to follow the study protocol - No medical, psychiatric, psychosocial conditions, or medications being taken that in the investigator's judgment would be a safety concern for participation in the study

Exclusion Criteria

  • Prior insulin treatment for stage 2 T1D - History of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any other clinically important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia) in the judgment of the investigator - Allergy or known hypersensitivity to human regular insulin - Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and/or positive cotinine test for smoking - Positive urine pregnancy test for female subjects of childbearing potential

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Afrezza (Technosphere Insulin) + Basal Insulin 		Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.
  • Drug: Technosphere Insulin
    2 unit
    Other names:
    • Afrezza
  • Drug: Technosphere Insulin
    4, 8, 12 units
    Other names:
    • Afrezza
  • Drug: Basal insulin
    subcutaneously-injected basal insulin

Recruiting Locations

Barbara Davis Center for Diabetes Young Adult Clinic
Aurora 5412347, Colorado 5417618 80045
Contact:
Cari Berget
303-724-8977
cari.berget@cuanschutz.edu

Joslin Diabetes Center
Boston 4930956, Massachusetts 6254926 02215
Contact:
Kerry Milaszewski
617-732-2603
Kerry.Milaszewski@joslin.harvard.edu

More Details

Status
Recruiting
Sponsor
Mannkind Corporation

Study Contact

Jennifer Pleitez
818-661-5032
jpleitez@mannkindcorp.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.