What this study is
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.
What's being tested
- Technosphere Insulin
Intervention · DRUG
2 unit
- Technosphere Insulin
Intervention · DRUG
4, 8, 12 units
- Basal insulin
Intervention · DRUG
subcutaneously-injected basal insulin
Study details
- Official title
- INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
- Sponsor
- Mannkind Corporation
- Conditions
- Type 1 Diabetes Mellitus
- Enrolling
- 100 people
- Starts
- 2026-02-04
- Est. completion
- 2027-09
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
10 openChildren's Hospital Los Angeles
Los Angeles, California, United States
- Pamela Parcon · Contact323-203-8744pparcon@chla.usc.edu
- Roshi Monzavi, MD · Principal investigator
RecruitingUniversity of California San Francisco
San Francisco, California, United States
- Avani Narayan · Contact415-530-8047Avani.Narayan@ucsf.edu
- Laya Ekhlaspour, MD · Principal investigator
RecruitingBarbara Davis Center for Diabetes Young Adult Clinic
Aurora, Colorado, United States
- Cari Berget · Contact303-724-8977cari.berget@cuanschutz.edu
- Gregory Forlenza, MD · Principal investigator
RecruitingYale University
New Haven, Connecticut, United States
- Amy Steffen, BSN · Contact203-737-8852Amy.steffen@yale.edu
- Jennifer Sherr, MD · Principal investigator
RecruitingUniversity of Florida
Gainsville, Florida, United States
- Sarah Peeling · Contact352-273-5275smpeeling@peds.ufl.edu
- Brittany Bruggeman, MD · Principal investigator
RecruitingIndiana University
Indianapolis, Indiana, United States
- Sana Kalaji · Contact317-274-0306skalaji@iu.edu
- Linda DiMeglio, MD · Principal investigator
RecruitingJoslin Diabetes Center
Boston, Massachusetts, United States
- Kerry Milaszewski · Contact617-975-8209Kerry.Milaszewski@joslin.harvard.edu
- Lori Laffel, MD · Principal investigator
RecruitingUniversity of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
- Deidre Graham, RN · Contact405-271-8001 ext. 34284deidre-graham@ou.edu
- David Sparling, MD · Principal investigator
RecruitingBaylor College of Medicine
Houston, Texas, United States
- Anh Nguyen · Contact832-822-3870anh.nguyen2@bcm.edu
- Daniel DeSalvo, MD · Principal investigator
RecruitingUniversity of Virginia
Charlottesville, Virginia, United States
- Sara Prince · Contact434-320-5599SP4SA@uvahealth.org
- Melissa Schoelwer, MD · Principal investigator
Recruiting
Study team
Sponsor
Mannkind Corporation
Study ID MKC-TI-196
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.