INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-17
SponsorMannkind Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Technosphere Insulin
- Technosphere Insulin
- Basal insulin
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Mannkind Corporation
Lead sponsor
Jaeb Center for Health Research
Collaborator
Source ClinicalTrials.gov