RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 13 weeks, 26 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe Afrezza is and how well it works with basal insulin shots in children ages 6 to 17 with newly diagnosed type 1 diabetes. Basal insulin is background insulin. The study also asks children and their parents or legal representatives how satisfied they are with the treatment.

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 6 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 6 to 17 years old.
  • Have newly diagnosed stage 3 type 1 diabetes, with high blood sugar that meets diabetes diagnosis rules.
  • Be able to start Afrezza with basal insulin within 21 days of diagnosis, counting the first insulin dose as day 1.
  • Have a breathing test result above 80% of the expected value. This test measures how much air you can blow out in one second.
  • The study doctor believes you can follow the study rules.
  • Have no health, mental health, or social concerns, or medicines, that the study doctor thinks would make joining unsafe.

Who can't join

  • Had insulin treatment for stage 2 type 1 diabetes, an earlier stage of the disease.
  • Have a history of long-term or serious lung disease, such as asthma, lung cancer, or cystic fibrosis, as judged by the study doctor.
  • Have an allergy or known sensitivity to regular human insulin.
  • Smoked cigarettes, cigars, pipes, or marijuana, or used vaping devices, within 3 months before screening, or have a positive cotinine test for smoking.
  • Have a positive urine pregnancy test if you can become pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 6 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

Study sites (10)

CA

CO

CT

FL

IN

MA

OK

TX

VA