Type 1 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Insulin, Inhaled, Afrezza, Technosphere, Pediatric, Inhaled Insulin, Type 1 Diabetes, Newly diagnosed type 1 diabetes, Technosphere Insulin, rapid-acting inhaled insulin, Meal-time inhaled insulin
Brief summary
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
2 unit
DRUGBasal insulin
subcutaneously-injected basal insulin
Sponsors
Mannkind Corporation
Jaeb Center for Health Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70% | 13 weeks | Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Continuous Glucose Monitoring (CGM) glucose | 13 weeks | Mean CGM glucose from baseline to 13 weeks |
| Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL | 13 weeks | Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL from baseline to 13 weeks |
| Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL | 13 weeks | CGM-measured percent time with glucose \> 180 mg/dL from baseline to 13 weeks |
| Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL | 13 weeks | Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL from baseline to 13 weeks |
| Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL | 13 weeks | Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL from baseline to 13 weeks |
| Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL | 13 weeks | Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL from baseline to 13 weeks |
| Continuous Glucose Monitoring (CGM) measured coefficient of variation | 13 weeks | CGM-measured coefficient of variation from baseline to 13 weeks |
| Change in glycated hemoglobin (HbA1c) | 13 weeks | Change in HbA1c from baseline to 13 weeks |
| Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver | 13 weeks | Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16; now listed as 1-5) and Delivery System subscale (items 17-22; now listed as 6-11) and one additional item added by study team (#12). Higher scores indicate less treatment satisfaction. |
| Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant | 13 weeks | Patient-reported outcome (PRO) survey for Insulin Treatment Satisfaction Questionnaire (ITSQ), customized for the study. Inconvenience subscale (items 1-3,15,16) and Delivery System subscale (items 17-22). Higher scores indicate less treatment satisfaction. |
| Percentage of participants using Afrezza and basal insulin (Afrezza-BI) regimen | At 13 weeks | Percentage of participants using Afrezza-BI regimen at time of 13-week visit |
| Percentage of participants that continue on the Afrezza and basal insulin (Afrezza-BI) regimen | After 13 weeks | Percentage of participants that continue on Afrezza-BI after 13-week visit |
| Incidence of Adverse Events of Special Interest (AESIs) | 13 weeks | Incidence and severity of AESIs which include the following events: acute bronchospasm, clinically relevant decline in pulmonary function (\>15% decline from baseline percent predicted FEV1 accompanied by respiratory symptoms), hypersensitivity reactions, including anaphylaxis, hospitalization for asthma, use of corticosteroid bursts for diagnosis of asthma, diagnosis of asthma, diabetic ketoacidosis, severe hypoglycemia |
| Change in percent predicted FEV1 | 13 weeks | Change in percent predicted FEV1 from baseline to Week 13 |
| Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 13 weeks | Incidence and severity of TEAEs and SAEs |
Countries
United States
Contacts
CONTACTJennifer Pleitez
Outcome results
None listed