Ertugliflozin for Sleep Apnea (ADIPOSA Trial)
Palo Alto (17 mi)Overseen byIan J Neeland, M.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Yale University
Prior Safety Data
Approved in 2 jurisdictions
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.
What safety data is available for Ertugliflozin?The safety data for Ertugliflozin primarily comes from studies related to its use in treating type 2 diabetes mellitus (T2DM). It has been evaluated in various clinical trials, including the VERTIS phase III program, which assessed its efficacy and safety as monotherapy and in combination with other antidiabetic drugs. The long-term safety was also evaluated in the 104-week VERTIS MET trial. However, there is no specific safety data available for its use in treating sleep apnea.12356
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are using sleep-inducing medications, SGLT2 inhibitors, GLP-1 receptor agonists, or if you are on certain diets or weight loss programs.
Is the drug Ertugliflozin (Steglatro) a promising treatment for sleep apnea?The research suggests that Ertugliflozin, a drug used for type 2 diabetes, may help reduce the occurrence of sleep apnea in patients with diabetes and heart disease.23578
What data supports the idea that the drug Ertugliflozin for Sleep Apnea is an effective treatment?The available research shows that Ertugliflozin is primarily studied and approved for treating type 2 diabetes, not sleep apnea. The studies focus on its ability to improve blood sugar control, reduce body weight, and lower blood pressure in diabetes patients. There is no data provided that supports its effectiveness for sleep apnea.12345
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.Treatment Details
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.
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
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Yale New Haven HealthNew Haven, CT
University Hospitals Cleveland Medical CenterCleveland, OH
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Who is running the clinical trial?
Yale UniversityLead Sponsor
Case Western Reserve UniversityCollaborator
References
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]To investigate the efficacy and safety of ertugliflozin, in a phase II dose-ranging study, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.
Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. [2020]Ertugliflozin is an oral sodium-glucose cotransporter 2 inhibitor that is being developed to treat type 2 diabetes mellitus (T2DM). This study assessed the efficacy and safety of co-initiation of ertugliflozin and sitagliptin compared with placebo in patients with T2DM inadequately controlled on diet and exercise.
Ertugliflozin: First Global Approval. [2019]Ertugliflozin (Steglatro™) is an orally active sodium glucose co-transporter type 2 inhibitor being developed by Merck and Pfizer as a treatment for type 2 diabetes mellitus (T2DM). Ertugliflozin as monotherapy and in combination with various other antidiabetic drugs was associated with improvements in glycaemic control and secondary outcome measures in the VERTIS phase III clinical trial program. Ertugliflozin and fixed-dose combinations of ertugliflozin and metformin (Segluromet™) and ertugliflozin and sitagliptin (Steglujan™) have recently been approved by the US FDA as an adjunct to diet and exercise to improve glycaemic control in adults with T2DM. These products have also received a positive opinion from the EU Committee for Medicinal Products for Human Use (CHMP). This article summarizes the milestones in the development of ertugliflozin leading to its first approval for T2DM.
Ertugliflozin as a monotherapy for the treatment of type 2 diabetes. [2019]Label="INTRODUCTION" NlmCategory="BACKGROUND">Sodium-dependent glucose transporter 2 (SGLT2) inhibitors are novel, potent oral anti-diabetic agents in a β-cell function-independent manner, inhibiting SGLT2-mediated renal glucose reabsorption and thus increasing urinary glucose excretion. Ertugliflozin (SteglatroTM) is a new oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes mellitus (T2DM) as a monotherapy or in combination with other anti-diabetic agents. Areas covered: This review summarizes the collected data concerning the pharmacokinetics, clinical efficacy, as well as safety and tolerability profiles of ertugliflozin given as a monotherapy for the management of T2DM. Expert opinion: Good glycemic control is crucial to the management of T2DM, and accordingly, anti-diabetic agents with various anti-hyperglycemic mechanisms are developed one after another. Based on the available clinical trials of ertugliflozin as a monotherapy for T2DM, it could be found that ertugliflozin effectively improves the glycemic control, body weight and blood pressure of patients with a low risk of hypoglycemia. It is also found that ertugliflozin moderately reduces their blood pressure, which is beneficial for decreasing the risk of cardiovascular disease. These attributes show the good potential of ertugliflozin as an adjunct treatment to diet and exercise for improving glycemic control in patients with T2DM.
Ertugliflozin (Steglatro): A New Option for SGLT2 Inhibition. [2020]Steglatro (ertugliflozin) for glycemic control in adults with type-2 diabetes mellitus.
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]To evaluate the long-term efficacy and safety of ertugliflozin in adults with type 2 diabetes mellitus inadequately controlled on metformin.
Ertugliflozin and incident obstructive sleep apnea: an analysis from the VERTIS CV trial. [2023]The sodium-glucose transporter 2 inhibitor (SGLT2i) empagliflozin may reduce the incidence of obstructive sleep apnea (OSA) in patients with type 2 diabetes (T2D) and cardiovascular (CV) disease. This analysis of VERTIS CV, the CV outcome trial for the SGLT2i ertugliflozin conducted in a similar group of patients, explored the effects of ertugliflozin on reported incident OSA.
Dapagliflozin initiation in chronic heart failure patients improves central sleep apnoea. [2023]Dapagliflozin decreases central sleep apnoea in central sleep apnoea patients, thereby sparing the initiation of ventilatory therapy https://bit.ly/41e2fm0.