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Recruiting NCT07224321

INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes

Phase II Interventional Type 1 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Technosphere Insulin, Technosphere Insulin, Basal insulin.
Who it may be relevant to
Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes

Overview

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.

Interventions

  • Drug Technosphere Insulin
    2 unit
  • Drug Technosphere Insulin
    4, 8, 12 units
  • Drug Basal insulin
    subcutaneously-injected basal insulin

Primary outcome measures

  • Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70% [Time frame: 13 weeks]
Secondary outcome measures (12)
  • Mean Continuous Glucose Monitoring (CGM) glucose [Time frame: 13 weeks]
  • Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL [Time frame: 13 weeks]
  • Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL [Time frame: 13 weeks]
  • Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL [Time frame: 13 weeks]
  • Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL [Time frame: 13 weeks]
  • Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL [Time frame: 13 weeks]
  • Continuous Glucose Monitoring (CGM) measured coefficient of variation [Time frame: 13 weeks]
  • Change in glycated hemoglobin (HbA1c) [Time frame: 13 weeks]
  • Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver [Time frame: 13 weeks]
  • Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant [Time frame: 13 weeks]
  • Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver [Time frame: 39 weeks]
  • Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant [Time frame: 39 weeks]

Eligibility criteria

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 21 days following T1D diagnosis (day 1 is based on the first insulin dose)
  • 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
  • In the judgment of the investigator, 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)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Children's Hospital Los Angeles — Los Angeles
  • University of California San Francisco — San Francisco
  • Barbara Davis Center for Diabetes Young Adult Clinic — Aurora
  • Yale University — New Haven
  • University of Florida — Gainesville
  • Indiana University — Indianapolis
  • Joslin Diabetes Center — Boston
  • University of Oklahoma Health Sciences Center — Oklahoma City
  • … and 2 more centers

Identifiers

NCT: NCT07224321 · MKC-TI-196

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗