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Insulin
Afrezza + Insulin Degludec for Type 1 Diabetes
Phase 4
Waitlist Available
Research Sponsored by Mannkind Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 weeks
Awards & highlights
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.
Who is the study for?
Adults over 18 with Type 1 Diabetes using multiple daily injections, an automated insulin delivery system, or a pump without automation and continuous glucose monitoring. They must be on a stable insulin regimen for at least 3 months, not have used inhaled insulin recently, and have no conditions that could affect safety or compliance.Check my eligibility
What is being tested?
The INHALE-3 trial is testing if combining Afrezza (inhaled insulin) with long-acting basal insulin degludec improves blood sugar control compared to usual care in adults with Type 1 Diabetes. Participants will either continue their current treatment or switch to the new combination for a total of 30 weeks.See study design
What are the potential side effects?
Potential side effects may include low blood sugar episodes (hypoglycemia), coughing, throat pain or irritation due to inhalation of Afrezza, and possible long-term effects on lung function. Insulin degludec can also cause hypoglycemia as well as reactions at the injection site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c
Secondary outcome measures
CGM-measured (24-hours) percent time in range with glucose 70-180 mg/dL
CGM-measured coefficient of variation
CGM-measured daytime (0600-midnight) percent time in range with glucose 70-180 mg/dL
+18 moreOther outcome measures
Area under the curve (AUC) for first meal challenge
Patient-reported outcome (PRO) questionnaires
Post prandial glucose for first meal challenge
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Afrezza (Technosphere Insulin) + insulin degludecExperimental Treatment2 Interventions
The Afrezza-Degludec group will inhale Afrezza at meals and corrections and will inject insulin degludec once a day for the 17 weeks of the RCT Phase. Dexcom CGM will be provided. The Afrezza-Degludec group will continue to use Afrezza and insulin degludec for an additional 13 weeks in the Extension Phase.
Group II: Usual Care: Insulin delivery with either MDI, a pump without automation, or an AID system and CGMActive Control2 Interventions
The Usual Care group will continue to receive insulin as they did before the study. This could be by injections or by using an insulin pump with or without automation for the 17 weeks of the RCT Phase. Participants will continue to use their personal CGM as they did before the study. The Usual Care group will then use Afrezza and insulin degludec for 13 weeks in the Extension Phase. Dexcom CGM will be provided during the Extension Phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afrezza
2017
Completed Phase 2
~30
insulin degludec
2015
Completed Phase 3
~4690
Find a Location
Who is running the clinical trial?
Mannkind CorporationLead Sponsor
56 Previous Clinical Trials
7,939 Total Patients Enrolled
Jaeb Center for Health ResearchOTHER
152 Previous Clinical Trials
34,528 Total Patients Enrolled
Irl B. Hirsch, MDStudy ChairUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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