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| Name | Class |
|---|---|
| Jaeb Center for Health Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afrezza (Technosphere Insulin) + Basal Insulin | Experimental | Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technosphere Insulin | Drug | 2 unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70% | Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Continuous Glucose Monitoring (CGM) glucose | Mean CGM glucose from baseline to 13 weeks | 13 weeks |
| Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL | Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL from baseline to 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Pleitez | Contact | 818-661-5032 | jpleitez@mannkindcorp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| Technosphere Insulin | Drug | 4, 8, 12 units |
|
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| Basal insulin | Drug | subcutaneously-injected basal insulin |
|
| 13 weeks |
| Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL | CGM-measured percent time with glucose > 180 mg/dL from baseline to 13 weeks | 13 weeks |
| Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL | Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL from baseline to 13 weeks | 13 weeks |
| Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL | Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL from baseline to 13 weeks | 13 weeks |
| Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL | Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL from baseline to 13 weeks | 13 weeks |
| Continuous Glucose Monitoring (CGM) measured coefficient of variation | CGM-measured coefficient of variation from baseline to 13 weeks | 13 weeks |
| Change in glycated hemoglobin (HbA1c) | Change in HbA1c from baseline to 13 weeks | 13 weeks |
| Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver | 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. | 13 weeks |
| Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant | 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. | 13 weeks |
| Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver | 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. | 39 weeks |
| Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant | 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. | 39 weeks |
| Percentage of participants using Afrezza and basal insulin (Afrezza-BI) regimen | Percentage of participants using Afrezza-BI regimen at time of 13-week visit | At 13 weeks |
| Percentage of participants that continue on the Afrezza and basal insulin (Afrezza-BI) regimen | Percentage of participants that continue on Afrezza-BI after 13-week visit | After 13 weeks |
| Incidence of Adverse Events of Special Interest (AESIs) | 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 | 13 weeks |
| Incidence of Adverse Events of Special Interest (AESIs) | 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 | 39 weeks |
| Change in percent predicted FEV1 | Change in percent predicted FEV1 from baseline to Week 13 | 13 weeks |
| Change in percent predicted FEV1 | Change in percent predicted FEV1 from baseline to Week 39 | 39 weeks |
| Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Incidence and severity of TEAEs and SAEs | 13 weeks |
| Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Incidence and severity of TEAEs and SAEs | 39 weeks |
| University of California San Francisco | Recruiting | San Francisco | California | 94158 | United States |
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| Barbara Davis Center for Diabetes Young Adult Clinic | Recruiting | Aurora | Colorado | 80045 | United States |
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| Yale University | Recruiting | New Haven | Connecticut | 06511 | United States |
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| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Joslin Diabetes Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Oklahoma Health Sciences Center | Not yet recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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