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Afrezza + Insulin Degludec for Type 1 Diabetes
Study Summary
This trial will test a new insulin regimen (inhaled plus long-acting) to see if it helps people with Type 1 diabetes better control their blood sugar.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing to undergo pregnancy tests if I can have children.I only have diabetes or no other conditions affecting my blood sugar levels.I've had a severe low blood sugar or DKA episode in the last 3 months.I haven't had a blood transfusion in the last 3 months and don't have conditions affecting HbA1c tests.I have used asthma medication in the last year or have a significant lung or heart condition.I have not smoked or used any tobacco products in the last 3 months.I have been using insulin for at least 6 months.I have been diagnosed with Type 1 Diabetes.I am not pregnant, breastfeeding, planning to become pregnant, or if capable of bearing children, I am using effective birth control.I am currently taking Hydroxyurea.My kidneys work well and I am not on dialysis.I use a long-acting insulin and mealtime insulin injections as prescribed.I have or had lung cancer.I have been using a rapid-acting insulin for at least 4 weeks.My daily insulin dose is between 20 and 100 units.I have taken diabetes medication that is not insulin in the last 3 months.I am 18 years old or older.I've been using the same diabetes treatment method for the last 3 months.I am not using any oral, inhaled, or injectable steroids for the trial duration.I haven't used inhaled insulin in the last 3 months.My automated insulin delivery system has been active for over 85% of the time in the last month.
- Group 1: Afrezza (Technosphere Insulin) + insulin degludec
- Group 2: Usual Care: Insulin delivery with either MDI, a pump without automation, or an AID system and CGM
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Is this research project actively seeking participants?
"Unfortunately, the information posted on clinicaltrials.gov indicates that this study is not presently enrolling new patients. It was first opened for applications on June 1st 2023 and was last updated 27th of the same month; however, there are currently 1250 other trials recruiting participants at this moment in time."
Are there any Canadian locations where this experiment is being conducted?
"This trial is running at a total of 15 sites, including the Barbara Davis Center in Aurora, Atlanta Diabetes Associates in Atlanta and Northwestern University Division of Endocrinology, Metabolism and Molecular Medicine in Chicago."
What regulatory approval has Afrezza (Technosphere Insulin) + insulin degludec attained?
"Given the Phase 4 nature of this trial, our analysts at Power assign a score of 3 for Afrezza (Technosphere Insulin) + insulin degludec's safety. This treatment has earned approval from regulatory authorities."
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