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
- 10 – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Mannkind Corporation · Industry
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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 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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 10 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 th…
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