Afrezza for Youth With Newly-Diagnosed Type 1 Diabetes
INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
Recruiting
Phase 2
Interventional Study
Type 1 Diabetes Mellitus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Mannkind Corporation · Industry
Who this trial is looking for
This trial is looking for young people aged 6 to under 18 with newly diagnosed type 1 diabetes. Participants will take a medication called Afrezza along with another insulin for 13 weeks, with a possible option to continue for another 26 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 6 and 17 years old.
- I have been diagnosed with type 1 diabetes.
- I can start treatment with Afrezza and insulin soon after my diagnosis.
- My lung function is more than 80% of the expected value.
- My doctor thinks I can follow the study steps.
- I am not taking any medications that could cause safety issues.
You may not be able to join if
- I have received insulin treatment for type 2 diabetes.
- I have a history of serious lung diseases like asthma or lung cancer.
- I am allergic to human regular insulin.
- I have smoked in the last 3 months.
- I have a positive urine pregnancy test.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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.…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts