Type 1 Diabetes MellitusPhase 2INHALE-1stNCT07224321
INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
A Phase 2 study testing Technosphere Insulin and Basal insulin in people with Type 1 Diabetes Mellitus, run by Mannkind Corporation at 10 sites in United States.
Trial 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 6 to <18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Technosphere Insulin and Basal insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- 4 Feb 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 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 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
Who cannot join
- 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/or positive cotinine test for smoking
- Positive urine pregnancy test for female subjects of childbearing potential
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Barbara Davis Center for Diabetes Young Adult Clinic
Aurora, Colorado, 80045
Cari Berget, 303-724-8977, cari.berget@cuanschutz.edu
Gregory Forlenza, MD
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Kerry Milaszewski, 617-975-8209, Kerry.Milaszewski@joslin.harvard.edu
Lori Laffel, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Sara Prince, 434-320-5599, SP4SA@uvahealth.org
Melissa Schoelwer, MD
- Recruiting
University of Florida
Gainsville, Florida, 32610
Sarah Peeling, 352-273-5275, smpeeling@peds.ufl.edu
Brittany Bruggeman, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Anh Nguyen, 832-822-3870, anh.nguyen2@bcm.edu
Daniel DeSalvo, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Sana Kalaji, 317-274-0306, skalaji@iu.edu
Linda DiMeglio, MD
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Pamela Parcon, 323-203-8744, pparcon@chla.usc.edu
Roshi Monzavi, MD
- Recruiting
Yale University
New Haven, Connecticut, 06511
Amy Steffen, BSN, 203-737-8852, Amy.steffen@yale.edu
Jennifer Sherr, MD
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Deidre Graham, RN, 405-271-8001 ext. 34284, deidre-graham@ou.edu
David Sparling, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Avani Narayan, 415-530-8047, Avani.Narayan@ucsf.edu
Laya Ekhlaspour, MD
About this study
Official title: INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
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 <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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Technosphere Insulin, Basal insulin
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere InsulinDrug
Also called Afrezza
2 unit
Technosphere InsulinDrug
Also called Afrezza
4, 8, 12 units
Basal insulinDrug
subcutaneously-injected basal insulin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Technosphere Insulin; Drug: Basal insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 13 weeks
Secondary outcomes (20)
Mean Continuous Glucose Monitoring (CGM) glucose
Mean CGM glucose from baseline to 13 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 13 weeks
Continuous Glucose Monitoring (CGM) measured coefficient of variation
CGM-measured coefficient of variation from baseline to 13 weeks
Measured: 13 weeks
Change in glycated hemoglobin (HbA1c)
Change in HbA1c from baseline to 13 weeks
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 39 weeks
Change in percent predicted FEV1
Change in percent predicted FEV1 from baseline to Week 13
Measured: 13 weeks
Change in percent predicted FEV1
Change in percent predicted FEV1 from baseline to Week 39
Measured: 39 weeks
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence and severity of TEAEs and SAEs
Measured: 13 weeks
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence and severity of TEAEs and SAEs
Measured: 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start4 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224321
- Sponsor's protocol ID
- MKC-TI-196
- Acronym
- INHALE-1st
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07224321
- Acronym / sponsor ID
- INHALE-1st / MKC-TI-196
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Insulin, Inhaled, Afrezza, Technosphere, Pediatric, Inhaled Insulin, Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 <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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afrezza (Technosphere Insulin) + Basal Insulin | Experimental | Drug: Technosphere Insulin, Drug: Basal insulinIndividualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 6 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 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
Key exclusion criteria (5 listed)
- 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/or positive cotinine test for smoking
- Positive urine pregnancy test for female subjects of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technosphere InsulinAlso: Afrezza2 unit | Drug | Afrezza (Technosphere Insulin) + Basal Insulin |
| Technosphere InsulinAlso: Afrezza4, 8, 12 units | Drug | Afrezza (Technosphere Insulin) + Basal Insulin |
| Basal insulinsubcutaneously-injected basal insulin | Drug | Afrezza (Technosphere Insulin) + Basal Insulin |
Primary outcome
Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%
Time frame: 13 weeks
Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit
20 secondary outcomes
Mean Continuous Glucose Monitoring (CGM) glucose
Time frame: 13 weeks
Continuous Glucose Monitoring (CGM) measured time-in-tight-range 70-140 mg/dL
Time frame: 13 weeks
Continuous Glucose Monitoring (CGM) measured percent time with glucose greater than 180 mg/dL
Time frame: 13 weeks
Continuous Glucose Monitoring (CGM) measured time with glucose greater than 250 mg/dL
Time frame: 13 weeks
Continuous Glucose Monitoring (CGM) measured time with glucose less than 70 mg/dL
Time frame: 13 weeks
Continuous Glucose Monitoring (CGM) measured time with glucose less than 54 mg/dL
Time frame: 13 weeks
Continuous Glucose Monitoring (CGM) measured coefficient of variation
Time frame: 13 weeks
Change in glycated hemoglobin (HbA1c)
Time frame: 13 weeks
Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver
Time frame: 13 weeks
Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant
Time frame: 13 weeks
Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Caregiver
Time frame: 39 weeks
Patient Reported Outcome: Insulin Treatment Satisfaction Questionnaire (ITSQ), Participant
Time frame: 39 weeks
Percentage of participants using Afrezza and basal insulin (Afrezza-BI) regimen
Time frame: At 13 weeks
Percentage of participants that continue on the Afrezza and basal insulin (Afrezza-BI) regimen
Time frame: After 13 weeks
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: 13 weeks
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: 39 weeks
Change in percent predicted FEV1
Time frame: 13 weeks
Change in percent predicted FEV1
Time frame: 39 weeks
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 13 weeks
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 39 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Technosphere Insulin and Basal insulin in people with Type 1 Diabetes Mellitus, run by Mannkind Corporation at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Pleitez (818-661-5032, jpleitez@mannkindcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70% (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.