Inhale-1st: Technosphere Insulin (Afrezza) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
Study on Investigational Insulin Treatment for Youth with Type 1 Diabetes
Linda DiMeglio, MD
Primary Investigator
Brief description of study
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.
Detailed description of study
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.
- Drug: Technosphere Insulin
- Drug: Basal insulin
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 1 Diabetes Mellitus, T1D, Riley
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Age: 10 years - 17 years
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Gender: All
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
This study investigates a treatment for youth aged 10 to under 18 who have recently been diagnosed with Type 1 diabetes. Type 1 diabetes is a chronic disease where the body's defense system mistakenly attacks specific cells within the pancreas, which make insulin. Insulin helps control sugar in the blood. When these cells are damaged, they cannot make enough insulin. This means people with Type 1 diabetes need to take insulin every day to keep their blood sugar at safe levels. The purpose of this study is to evaluate the safety and effectiveness of an investigational inhaled insulin in combination with a basal insulin, which is a long-acting insulin injected under the skin.
Participants will receive the investigational inhaled insulin along with the basal insulin. They will be monitored to ensure the treatment is safe and to see how well it works. The study will also gather feedback from participants and their parents or guardians about their satisfaction with the treatment. Participants will be followed for 13 weeks in the main phase, with an option to continue for an additional 26 weeks.
- Who can participate: Children and teenagers aged 10 to under 18 with a recent diagnosis of stage 3 Type 1 diabetes can participate. Participants must not have prior insulin treatment for stage 2 Type 1 diabetes and should not have any chronic lung diseases. They must also be non-smokers and not pregnant.
- Study details: Participants will take an investigational inhaled insulin along with a basal insulin injection. They will provide feedback on their experience with the treatment. An inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine is called a placebo, but it is not used in this study.
- Study timelines: The study will last 13 weeks.
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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