Ertugliflozin for Sleep Apnea

(ADIPOSA Trial)

Recruiting at 1 trial location

Overseen By Henry K Yaggi, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Yale University

Must not be taking: Sleep-inducing, SGLT2i, GLP-1 agonists, UGT inducers

Disqualifiers: Type 1 diabetes, Severe liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

164 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug). The main question it aims to answer is: * If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants * If improvement in clinical measures are because of improvement in the anatomic and physiologic traits. Participants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take sleep-inducing medications, SGLT2 inhibitors, GLP-1 receptor agonists, or UGT inducers during the study.

Is Ertugliflozin safe for humans?

Ertugliflozin, also known as Steglatro, has been studied for safety in people with type 2 diabetes and is generally considered safe when used as directed. It has been tested in combination with other diabetes medications and has received approval from health authorities like the US FDA and the EU Committee for Medicinal Products for Human Use. ^{1 2 3 4 5}

How does the drug Ertugliflozin differ from other treatments for sleep apnea?

Ertugliflozin is unique because it is primarily a diabetes medication that works by blocking a protein in the kidneys to lower blood sugar, and it is being explored for its potential to reduce sleep apnea, unlike traditional treatments that focus on airway management. ^{1 4 5 6 7}

Research Team

Henry K Yaggi, M.D.

Principal Investigator

Yale University

Ian J Neeland, M.D.

Principal Investigator

Case Western Reserve University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

Overweight or obese (body mass index 25-40 kg/m2)

I have been diagnosed with obstructive sleep apnea with an AHI or REI of 15 or more.

Able to provide informed consent and stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Currently or planning to follow a ketogenic diet pattern ('keto diet') prior to or during enrollment in the study

I have Type 1 diabetes.

I am not pregnant, breastfeeding, or planning to become pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bexagliflozin or placebo once daily for 6 months, with routine clinical care

6 months

Baseline, 3 months, and 6 months visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ertugliflozin
• Placebo

Trial Overview 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.

Participant Groups

Group I: Bexagliflozin Experimental Treatment 1 Intervention

Bexagliflozin once daily for 6 months

Group II: Placebo Placebo Group 1 Intervention

Placebo once daily for 6 months

Ertugliflozin is already approved in United States, European Union for the following indications:

Approved in United States as Steglatro for:

• Type 2 diabetes mellitus

Approved in European Union as Steglatro for:

• Type 2 diabetes mellitus

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Findings from Research

Ertugliflozin, a sodium glucose co-transporter type 2 inhibitor, has shown significant improvements in glycaemic control in type 2 diabetes patients during the VERTIS phase III clinical trial program.

Ertugliflozin, both as a standalone treatment and in combination with other medications like metformin and sitagliptin, has been approved by the US FDA and received positive feedback from the EU for its effectiveness in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ertugliflozin: First Global Approval. Markham, A.[2019]

Ertugliflozin effectively reduced HbA1c levels and improved fasting plasma glucose, body weight, and systolic blood pressure in adults with type 2 diabetes over a 104-week study, demonstrating sustained efficacy.

While ertugliflozin was well tolerated, it was associated with a higher incidence of female genital mycotic infections, but it also resulted in fewer cases of symptomatic hypoglycemia compared to placebo or glimepiride.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: 104-week VERTIS MET trial. Gallo, S., Charbonnel, B., Goldman, A., et al.[2022]

In a phase II study involving 328 patients with type 2 diabetes, ertugliflozin significantly reduced HbA1c levels, fasting plasma glucose, and body weight compared to placebo, demonstrating its efficacy in improving glycemic control.

Ertugliflozin was well tolerated with a low incidence of adverse events, including only 1.5% experiencing hypoglycemia, and showed no dose-related increase in adverse events, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. Amin, NB., Wang, X., Jain, SM., et al.[2022]

Steglatro (ertugliflozin) has been shown to effectively improve glycemic control in adults with type-2 diabetes mellitus, making it a valuable option for managing this condition.

The efficacy of Steglatro was evaluated through clinical trials, demonstrating its ability to lower blood sugar levels in patients, which is crucial for preventing complications associated with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ertugliflozin (Steglatro): A New Option for SGLT2 Inhibition. Kovacich, N., Chavez, B.[2020]

In a 26-week phase III study involving 291 patients with type 2 diabetes, co-initiation of ertugliflozin and sitagliptin significantly reduced HbA1c levels compared to placebo, with reductions of -1.6% and -1.7% for the respective doses of ertugliflozin.

The combination treatment also led to significant improvements in fasting plasma glucose, body weight, and systolic blood pressure, while the safety profile was similar across all groups, with low incidences of specific adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. Miller, S., Krumins, T., Zhou, H., et al.[2020]

In a study involving 8246 patients with type 2 diabetes and cardiovascular disease, the SGLT2 inhibitor ertugliflozin significantly reduced the incidence of obstructive sleep apnea (OSA) by 48% compared to placebo, with an incidence rate of 1.44 vs. 2.61 per 1000 person-years.

This exploratory analysis suggests that SGLT2 inhibitors like ertugliflozin may provide additional benefits beyond glucose control, potentially improving sleep-related health in patients with diabetes and cardiovascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ertugliflozin and incident obstructive sleep apnea: an analysis from the VERTIS CV trial. Wojeck, BS., Inzucchi, SE., Neeland, IJ., et al.[2023]

Dapagliflozin has been found to reduce the occurrence of central sleep apnea in patients diagnosed with this condition, which is significant as it may help avoid the need for more invasive ventilatory therapies.

This finding suggests that dapagliflozin could be a beneficial treatment option for managing central sleep apnea, potentially improving patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin initiation in chronic heart failure patients improves central sleep apnoea. Jaffuel, D., Bouchaut, Y., Mallet, JP., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Ertugliflozin: First Global Approval. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: 104-week VERTIS MET trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ertugliflozin (Steglatro): A New Option for SGLT2 Inhibition. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Ertugliflozin and incident obstructive sleep apnea: an analysis from the VERTIS CV trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Dapagliflozin initiation in chronic heart failure patients improves central sleep apnoea. [2023]