[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07224321":3,"trial-entities:NCT07224321":296,"trial-summary:NCT07224321":299},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":54,"secondary_outcomes":59,"sex":116,"minimum_age":117,"maximum_age":118,"healthy_volunteers":119,"eligibility_criteria":120,"std_ages":135,"locations":137,"central_contacts":288,"overall_officials":293,"references":294,"see_also_links":295},"NCT07224321","MKC-TI-196","INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes","INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes","RECRUITING","2027-09","2026-08","2026-08-13","2026-02-04","Mannkind Corporation","INDUSTRY",null,"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 6 to \\\u003C18 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\u002Flegally 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.",[18],"Type 1 Diabetes Mellitus",[20,21,22,23,24,25,26,27,28,29,30,31],"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","INTERVENTIONAL","TREATMENT",[35],"PHASE2",{"count":37,"type":38},100,"ESTIMATED",[40,46,50],{"type":41,"name":29,"description":42,"armGroupLabels":43,"otherNames":45},"DRUG","2 unit",[44],"Afrezza (Technosphere Insulin) + Basal Insulin",[23],{"type":41,"name":29,"description":47,"armGroupLabels":48,"otherNames":49},"4, 8, 12 units",[44],[23],{"type":41,"name":51,"description":52,"armGroupLabels":53},"Basal insulin","subcutaneously-injected basal insulin",[44],[55],{"measure":56,"description":57,"timeFrame":58},"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\u002FdL ≥70% during 14 days prior to 13-week visit","13 weeks",[60,63,66,69,72,75,78,81,84,87,90,93,95,99,103,106,107,110,112,115],{"measure":61,"description":62,"timeFrame":58},"Mean Continuous Glucose Monitoring (CGM) glucose","Mean CGM glucose from baseline to 13 weeks",{"measure":64,"description":65,"timeFrame":58},"Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg\u002FdL","Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg\u002FdL from baseline to 13 weeks",{"measure":67,"description":68,"timeFrame":58},"Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg\u002FdL","CGM-measured percent time with glucose \\> 180 mg\u002FdL from baseline to 13 weeks",{"measure":70,"description":71,"timeFrame":58},"Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg\u002FdL","Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg\u002FdL from baseline to 13 weeks",{"measure":73,"description":74,"timeFrame":58},"Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg\u002FdL","Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg\u002FdL from baseline to 13 weeks",{"measure":76,"description":77,"timeFrame":58},"Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg\u002FdL","Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg\u002FdL from baseline to 13 weeks",{"measure":79,"description":80,"timeFrame":58},"Continuous Glucose Monitoring (CGM) measured coefficient of variation","CGM-measured coefficient of variation from baseline to 13 weeks",{"measure":82,"description":83,"timeFrame":58},"Change in glycated hemoglobin (HbA1c)","Change in HbA1c from baseline to 13 weeks",{"measure":85,"description":86,"timeFrame":58},"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.",{"measure":88,"description":89,"timeFrame":58},"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.",{"measure":85,"description":91,"timeFrame":92},"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",{"measure":88,"description":94,"timeFrame":92},"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.",{"measure":96,"description":97,"timeFrame":98},"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",{"measure":100,"description":101,"timeFrame":102},"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",{"measure":104,"description":105,"timeFrame":58},"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",{"measure":104,"description":105,"timeFrame":92},{"measure":108,"description":109,"timeFrame":58},"Change in percent predicted FEV1","Change in percent predicted FEV1 from baseline to Week 13",{"measure":108,"description":111,"timeFrame":92},"Change in percent predicted FEV1 from baseline to Week 39",{"measure":113,"description":114,"timeFrame":58},"Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","Incidence and severity of TEAEs and SAEs",{"measure":113,"description":114,"timeFrame":92},"ALL","6 Years","17 Years",false,{"inclusion":121,"exclusion":128,"raw_text":134},[122,123,124,125,126,127],"Age 6 to \\\u003C18 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","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",[129,130,131,132,133],"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\u002For positive cotinine test for smoking","Positive urine pregnancy test for female subjects of childbearing potential","Inclusion Criteria:\n\n* Age 6 to \\\u003C18 years of age\n* Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria\n* Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose)\n* Forced Expiratory Volume in One Second (FEV1) \\>80.0% of predicted Global Lung Function Initiative (GLI) value\n* Investigator believes that participant can be expected to follow the study protocol\n* 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\n\nExclusion Criteria:\n\n* Prior insulin treatment for stage 2 T1D\n* 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)\n* Allergy or known hypersensitivity to human regular insulin\n* Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and\u002For positive cotinine test for smoking\n* Positive urine pregnancy test for female subjects of childbearing potential",[136],"CHILD",[138,156,170,185,200,212,227,242,258,273],{"facility":139,"status":8,"city":140,"state":141,"zip":142,"country":143,"contacts":144,"geoPoint":153},"Children's Hospital Los Angeles","Los Angeles","California","90027","United States",[145,150],{"name":146,"role":147,"phone":148,"email":149},"Pamela Parcon","CONTACT","323-203-8744","pparcon@chla.usc.edu",{"name":151,"role":152},"Roshi Monzavi, MD","PRINCIPAL_INVESTIGATOR",{"lat":154,"lon":155},34.05223,-118.24368,{"facility":157,"status":8,"city":158,"state":141,"zip":159,"country":143,"contacts":160,"geoPoint":167},"University of California San Francisco","San Francisco","94158",[161,165],{"name":162,"role":147,"phone":163,"email":164},"Avani Narayan","415-530-8047","Avani.Narayan@ucsf.edu",{"name":166,"role":152},"Laya Ekhlaspour, MD",{"lat":168,"lon":169},37.77493,-122.41942,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":143,"contacts":175,"geoPoint":182},"Barbara Davis Center for Diabetes Young Adult Clinic","Aurora","Colorado","80045",[176,180],{"name":177,"role":147,"phone":178,"email":179},"Cari Berget","303-724-8977","cari.berget@cuanschutz.edu",{"name":181,"role":152},"Gregory Forlenza, MD",{"lat":183,"lon":184},39.72943,-104.83192,{"facility":186,"status":8,"city":187,"state":188,"zip":189,"country":143,"contacts":190,"geoPoint":197},"Yale University","New Haven","Connecticut","06511",[191,195],{"name":192,"role":147,"phone":193,"email":194},"Amy Steffen, BSN","203-737-8852","Amy.steffen@yale.edu",{"name":196,"role":152},"Jennifer Sherr, MD",{"lat":198,"lon":199},41.30815,-72.92816,{"facility":201,"status":8,"city":202,"state":203,"zip":204,"country":143,"contacts":205},"University of Florida","Gainsville","Florida","32610",[206,210],{"name":207,"role":147,"phone":208,"email":209},"Sarah Peeling","352-273-5275","smpeeling@peds.ufl.edu",{"name":211,"role":152},"Brittany Bruggeman, MD",{"facility":213,"status":8,"city":214,"state":215,"zip":216,"country":143,"contacts":217,"geoPoint":224},"Indiana University","Indianapolis","Indiana","46202",[218,222],{"name":219,"role":147,"phone":220,"email":221},"Sana Kalaji","317-274-0306","skalaji@iu.edu",{"name":223,"role":152},"Linda DiMeglio, MD",{"lat":225,"lon":226},39.76838,-86.15804,{"facility":228,"status":8,"city":229,"state":230,"zip":231,"country":143,"contacts":232,"geoPoint":239},"Joslin Diabetes Center","Boston","Massachusetts","02215",[233,237],{"name":234,"role":147,"phone":235,"email":236},"Kerry Milaszewski","617-975-8209","Kerry.Milaszewski@joslin.harvard.edu",{"name":238,"role":152},"Lori Laffel, MD",{"lat":240,"lon":241},42.35843,-71.05977,{"facility":243,"status":8,"city":244,"state":245,"zip":246,"country":143,"contacts":247,"geoPoint":255},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",[248,253],{"name":249,"role":147,"phone":250,"phoneExt":251,"email":252},"Deidre Graham, RN","405-271-8001","34284","deidre-graham@ou.edu",{"name":254,"role":152},"David Sparling, MD",{"lat":256,"lon":257},35.46756,-97.51643,{"facility":259,"status":8,"city":260,"state":261,"zip":262,"country":143,"contacts":263,"geoPoint":270},"Baylor College of Medicine","Houston","Texas","77030",[264,268],{"name":265,"role":147,"phone":266,"email":267},"Anh Nguyen","832-822-3870","anh.nguyen2@bcm.edu",{"name":269,"role":152},"Daniel DeSalvo, MD",{"lat":271,"lon":272},29.76328,-95.36327,{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":143,"contacts":278,"geoPoint":285},"University of Virginia","Charlottesville","Virginia","22903",[279,283],{"name":280,"role":147,"phone":281,"email":282},"Sara Prince","434-320-5599","SP4SA@uvahealth.org",{"name":284,"role":152},"Melissa Schoelwer, MD",{"lat":286,"lon":287},38.02931,-78.47668,[289],{"name":290,"role":147,"phone":291,"email":292},"Jennifer Pleitez","818-661-5032","jpleitez@mannkindcorp.com",[],[],[],{"nct_id":4,"conditions":297,"biomarkers":298},[18],[],{"nct_id":4,"found":300,"summary":301,"prompt_version":311},true,{"design":302,"status":303,"heading":304,"summary":305,"follow_up":306,"word_count":307,"commitments":308,"compensation":309,"drugs_mentioned":310},"This is a Phase 2 study with 100 planned participants. It is a single-arm study, meaning all participants will receive the same treatment combination.","completed","INHALE-1st: Afrezza® for Youth with Newly-Diagnosed Type 1 Diabetes","This study, called INHALE-1st, is looking at how well Afrezza (an inhaled insulin) works when combined with basal insulin (insulin injected under the skin) for young people aged 10 to 17 who have been recently diagnosed with Type 1 Diabetes. The study wants to see if this combination helps keep blood sugar levels in a healthy range (Time in Range, or TIR). You could join if you are 10 to 17 years old, have newly diagnosed Type 1 Diabetes, and meet certain lung function requirements. The study also wants to understand how satisfied participants and their parents are with this treatment. The study is currently unclear on its recruitment status.","Participants will be followed for 13 weeks during the main phase, with an optional extension phase for up to 26 weeks.",110,"Participants will be followed for 13 weeks in the main part of the study, with an option to continue for up to 26 weeks.","Not stated in the trial record.",[51],"v2"]