Afrezza® INHALE-1 Study in Pediatrics

Inclusion Criteria:

• Assent from the pediatric subject, as appropriate, and fully informed consent fromthe parent(s) or legal guardian, as required by both state and federal laws and thelocal Institutional Review Board (IRB)

• Subjects ≥4 and <18 years of age

• Clinical diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) per the Investigator and have been using insulin for at least 6 months forT1DM, or at least 3 months for T2DM

• Treatment with basal-bolus insulin therapy delivered by multiple daily injectionsfor at least 2 weeks

• Bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulinglulisine, including biosimilar products

• Basal insulins are restricted to insulin glargine, insulin degludec or insulindetemir, including biosimilar products

• Access to stable WiFi connection

• HbA1c ≥7.0% and ≤11%

• Average prandial dose of insulin ≥2 units per meal

• Utilized CGM for ≥70% of the time over a consecutive 14-day period precedingrandomization

Exclusion Criteria:

• History of recent blood transfusions (within previous 3 months), hemoglobinopathies,or any other conditions that affect HbA1c measurements

• Recent history of asthma (defined as using any medications to treat within the lastyear), any other clinically important pulmonary disease (e.g., cystic fibrosis orbronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonarydisease

• History of serious complications of diabetes (e.g., active proliferative retinopathyor symptomatic autonomic neuropathy), or likely need for specific treatment fordiabetic retinopathy (laser photocoagulation, vitrectomy, other) in the next year

• FEV1 and FEV1/forced vital capacity (FVC) ≤80% of predicted Global Lung FunctionInitiative (GLI) value

• Inability to achieve an acceptable FEV1 and FVC reading for subjects ≥8 years of agewould make the subject ineligible

• For subjects <8 years of age who are unable to achieve an acceptable FVC reading,FEV1 only may be assessed; inability to achieve an acceptable FEV1 would make thesubject ineligible

• Respiratory tract infection within 14 days before screening (subject may return 14days after resolution of symptoms for rescreening)

• Inability or unwillingness to perform study procedures

• Exposure to any investigational product(s), including drugs or devices, in the past 30 days

• Any disease other than diabetes or exposure to any medication that, in the judgmentof the Investigator, may impact glucose metabolism and current or anticipated acuteuses of glucocorticoids or weight loss medications, with the exception of metforminand/or GLP-1 agonists (if GLP-1 agonists used for at least the 3 months prior toenrollment) in subjects with T2DM

• Use of antiadrenergic drugs (e.g., clonidine)

• Any concurrent illness (other than diabetes mellitus) not controlled by a stabletherapeutic regimen

• Current uncontrolled eating disorder (e.g., anorexia or bulimia nervosa)

• Current drug or alcohol abuse or a history of drug or alcohol abuse that, in theopinion of the Investigator or the Sponsor, would make the subject an unsuitablecandidate for participation in the study

• Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for thepreceding 6 months and/or positive urine cotinine test

• Female subject who is pregnant, breast-feeding, intends to become pregnant, or is ofchild-bearing potential, sexually active and not using adequate contraceptivemethods as required by local regulation or practice

• An event of severe hypoglycemia, as judged by the Investigator, within the last 90days prior to screening

• An episode of DKA requiring hospitalization within the last 90 days prior toscreening