Actively Recruiting
INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
Led by Mannkind Corporation · Updated on 2026-05-05
100
Participants Needed
10
Research Sites
82 weeks
Total Duration
On this page
Sponsors
M
Mannkind Corporation
Lead Sponsor
J
Jaeb Center for Health Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 10 to less than 18 years
- Clinical diagnosis of stage 3 type 1 diabetes
- Able to start Afrezza plus basal insulin regimen within 21 days after diagnosis
- Forced Expiratory Volume in One Second (FEV1) greater than 80% of predicted value
- Investigator believes participant can follow study protocol
- No medical, psychiatric, psychosocial conditions, or medications that pose safety concerns as judged by investigator
You will not qualify if you...
- Prior insulin treatment for stage 2 type 1 diabetes
- History of chronic lung diseases such as asthma, chronic obstructive pulmonary disease, lung cancer, cystic fibrosis, or bronchopulmonary dysplasia
- Allergy or known hypersensitivity to human regular insulin
- Smoking within 3 months prior to screening or positive cotinine test
- Positive urine pregnancy test for females of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Not Yet Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94158
Not Yet Recruiting
3
Barbara Davis Center for Diabetes Young Adult Clinic
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06511
Not Yet Recruiting
5
University of Florida
Gainesville, Florida, United States, 32610
Not Yet Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
7
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
9
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
10
University of Virginia
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
Research Team
J
Jennifer Pleitez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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