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SGLT2 Inhibitor
Ertugliflozin for Sleep Apnea (ADIPOSA Trial)
Phase 4
Waitlist Available
Led By Ian J Neeland, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinically confirmed diagnosis of obstructive sleep apnea by one of the following methods: Polysomnography: AHI ≥15/hour sleep or Home sleep apnea testing: Respiratory event index (REI) ≥15/hour sleep
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months and 6 months
Awards & highlights
ADIPOSA Trial Summary
This trial tests if a drug can reduce sleep apnea severity in overweight/obese adults w/ moderate-severe OSA vs. a placebo. Participants will get routine care and undergo tests to check drug effectiveness.
Who is the study for?
The ADIPOSA study is for overweight or obese adults with moderate to severe obstructive sleep apnea (OSA). Participants must be able to consent, follow the study plan for 6 months, and have a confirmed OSA diagnosis. Excluded are those planning certain weight loss treatments, with hypersensitivity to the drug tested, pregnant women, users of sleep-inducing meds, and individuals with specific medical conditions or inability to undergo MRI.Check my eligibility
What is being tested?
This trial tests if Ertugliflozin can reduce the severity of sleep apnea in comparison to a placebo. It examines whether improvements in clinical measures of OSA result from changes in anatomic and physiologic traits. Participants will receive either the drug or placebo alongside routine care for six months while undergoing various clinical measurements.See study design
What are the potential side effects?
Potential side effects may include urinary tract infections, genital mycotic infections due to SGLT2 inhibitors like Ertugliflozin. The exact side effects will be monitored throughout the trial as participants' reactions can vary.
ADIPOSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with obstructive sleep apnea with an AHI or REI of 15 or more.
ADIPOSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Apnea hypopnea index (AHI) measured by full ambulatory polysomnography (aPSG)
Secondary outcome measures
Change in 24 hour ambulatory average diastolic blood pressure
Change in 24 hour ambulatory average systolic blood pressure
Change in 24 hour ambulatory blood pressure variability
+24 moreADIPOSA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BexagliflozinExperimental Treatment1 Intervention
Bexagliflozin once daily for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo once daily for 6 months
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,249 Total Patients Enrolled
2 Trials studying Sleep Apnea
117 Patients Enrolled for Sleep Apnea
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,923 Total Patients Enrolled
Ian J Neeland, M.D.Principal InvestigatorCase Western Reserve University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Type 1 diabetes.I am not pregnant, breastfeeding, or planning to become pregnant.I have severe liver disease.My kidney function is low, with an eGFR under 30.I have had diabetic ketoacidosis in the past.I understand and can communicate about my health condition.I have been diagnosed with obstructive sleep apnea with an AHI or REI of 15 or more.I am currently taking or plan to take an SGLT2 inhibitor.I am allergic to bexagliflozin or its ingredients.I have an ulcer on my lower limb due to diabetes or another cause.I am currently on or planning to start a weight loss program.I am not taking any drugs that speed up drug breakdown.I am currently taking or plan to take a GLP-1 receptor agonist.I have a sleep disorder not related to obstructive sleep apnea.I have severe leg artery disease with pain when walking or have had surgery to improve blood flow to my legs.I use medications to help me sleep.
Research Study Groups:
This trial has the following groups:- Group 1: Bexagliflozin
- Group 2: Placebo
Awards:
This trial has 2 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.
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.
Are there still openings for participants in this trial?
"Based on the information located at clinicaltrials.gov, this medical research is no longer recruiting patients as it was last updated November 3rd 2022. Nevertheless, there are presently 257 other trials actively looking for participants right now."
Answered by AI
Is Ertugliflozin a risk-free option for people?
"With Ertugliflozin being an approved treatment, it has been awarded a score of 3 for safety."
Answered by AI
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