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SGLT2 Inhibitor
Ertugliflozin for Sleep Apnea (ADIPOSA Trial)
Phase 4
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months and 6 months
Awards & highlights
Drug Has Already Been Approved
Pivotal 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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Apnea hypopnea index (AHI) measured by full ambulatory polysomnography (aPSG)
Secondary study objectives
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 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
1,930 Previous Clinical Trials
3,033,294 Total Patients Enrolled
2 Trials studying Sleep Apnea
117 Patients Enrolled for Sleep Apnea
Case Western Reserve UniversityOTHER
309 Previous Clinical Trials
251,095 Total Patients Enrolled
Ian J Neeland, M.D.Principal InvestigatorCase Western Reserve University School of Medicine
Henry K Yaggi, M.D.Principal InvestigatorYale University
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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:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.