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Inhaled Insulin for Diabetes in Children (INHALE-1 Trial)
INHALE-1 Trial Summary
This trial is testing the efficacy and safety of Afrezza, a inhaled insulin, in children with type 1 or 2 diabetes. The trial has a screening and run-in period of up to 5 weeks, followed by a 26-week randomized treatment period, during which subjects will receive either Afrezza or a rapid-acting insulin injection. All subjects will then enter a 26-week treatment extension, during which they will receive Afrezza. The trial will conclude with a 4-week follow-up period.
INHALE-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowINHALE-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 30 Patients • NCT02527265INHALE-1 Trial Design
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- I have diabetes and have been using insulin for the required time.I have asthma or another serious lung or heart condition.You had a very low blood sugar event in the last 90 days.I was hospitalized for diabetic ketoacidosis within the last 3 months.I have had a blood transfusion, a blood disorder, or a condition that affects HbA1c tests in the last 3 months.You have smoked cigarettes, cigars, pipes, marijuana, or used vaping devices in the last 6 months, or your urine test shows evidence of smoking.I only have diabetes and no other conditions affecting my blood sugar, except for controlled use of specific diabetes medications.You have used continuous glucose monitoring for at least 70% of the time over a 14-day period before joining the study.I am taking medication that affects my adrenaline levels.I am using insulin glargine, degludec, or detemir for my diabetes.I have serious diabetes complications like vision problems or nerve damage.You currently have an eating disorder that is not under control.I am under 8 and cannot perform the FVC breathing test properly.Your lung function test results show that your breathing capacity is less than 80% of what is expected for someone of your age and size.Your HbA1c level is between 7.0% and 11%.I am unable or unwilling to follow the study's required procedures.I am between 4 and 17 years old.I have been on a basal-bolus insulin regimen with multiple daily injections for at least 2 weeks.I only use rapid-acting insulins like lispro, aspart, or glulisine.I take 2 or more units of insulin with each meal.I haven't had a respiratory infection in the last 14 days.All my illnesses except diabetes are under control with stable treatment.My lung function tests are below the required levels.I am not pregnant, breastfeeding, planning to become pregnant, or if capable of becoming pregnant, I am using effective birth control.
- Group 1: Afrezza (Technosphere Insulin) + Basal Insulin
- Group 2: RAA Injection + Basal Insulin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any other ongoing trials that are testing Afrezza's effects?
"According to our research, 114 clinical trials involving Afrezza are currently ongoing with 26 of them in Phase 3. Tustin, California appears to be a hub for this medication with 801 total locations running trials."
Are there any harmful side effects associated with Afrezza?
"Our team at Power estimates that Afrezza is safe to use, scoring it a 3 on our safety scale. This is because Afrezza is a Phase 3 trial drug, meaning that there is some data supporting its efficacy and multiple rounds of data supporting its safety."
Is this a fully enrolled clinical trial or are there still opportunities for people to participate?
"The trial is currently ongoing and searching for participants. The study was first posted on September 29th, 2021 with the most recent update occurring on November 4th, 2022."
Are there numerous sites within the US conducting this research?
"There are a total of 32 sites where this clinical trial is being offered, with locations such as Hassenfeld Children's Hospital at NYU Langone in New york, Cincinnati Children's Hospital in Cincinnati, and the University of Louisville Research Foundation/KCPCRU in Louisville."
Can people who are younger than 40 years old participate in this experiment?
"The age bracket that this clinical trial is recruiting people from is 4 years old up to 17 years old."
For what reasons is Afrezza most commonly recommended?
"Afrezza can be used as an effective treatment for communicable diseases, liraglutide, and exercise."
How many patients are being given this new medication to test its effects?
"In order to initiate this clinical trial, 264 willing and eligible patients are required. These participants can be sourced from various locations, such as the University of Louisville Research Foundation/KCPCRU in Louisville, Kentucky or Cincinnati Children's Hospital in Cincinnati, Ohio."
How can I sign up to help with this research?
"This trial is currently recruiting 264 participants aged 4-17 with type 2 diabetes mellitus. Key inclusion criteria are as follows: must have assent from the pediatric subject (if appropriate) and informed consent from parent or legal guardian, be diagnosed with T1DM or T2DM, have been using insulin for at least 6 months (T1DM) or 3 months (T2DM), be on basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks, use bolus insulins lispro/aspart/glulisine or biosimilar products and basal insulins glargine/deg"
Who else is applying?
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What portion of applicants met pre-screening criteria?
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