New Drug Studied for Diabetes Heart Complication
By Arvind Sommi
Approximately 17% of people with diabetes have diabetic cardiomyopathy, a dangerous complication that can lead to heart failure. This clinical trial is focused on investigating a new medication for people with type 2 diabetes experiencing this condition.
Clinical Trials Identifier: NCT04083339
Trial Name: Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
Diabetes Type: Adults with type 2 diabetes
Trial Sponsor: Applied Therapeutics, Inc.
What is the purpose of this trial?
This study will enroll 675 participants with type 2 diabetes and diabetic cardiomyopathy to evaluate the safety and efficacy of a new drug, currently named AT-001. Participants will be randomly assigned to receive either a high dose of AT-001, a low dose of AT-001, or a placebo. AT-001 will be administered orally twice daily – before breakfast and before dinner.
The primary goal of the study is to see if AT-001 can improve or prevent the decline of functional capacity of the heart in people with diabetic cardiomyopathy (DCM). Fifteen months after the start of the trial, researchers will measure peak VO2, the maximum amount of oxygen the body can use during exercise.
Why is this trial important?
Cardiomyopathy is a condition that impacts heart muscles – making it more difficult for the heart to pump blood to the rest of the body – and usually presents as heart failure. It is apparent that hyperglycemia over many years can lead to the initial development of DCM. Among people with diabetes, nearly a quarter experience heart failure, and about 17% have DCM.
Currently, there are a few approved therapies for heart failure. Certain diabetes medications, such as SGLT-2 inhibitors like Jardiance (empagliflozin) or Farxiga (dapagliflozin), provide cardioprotective effects and are indicated for heart failure regardless of the cause. However, no therapies specifically target DCM.
This phase 3 clinical trial will assess whether or not AT-001 can directly prevent the progression of DCM by inhibiting a specific molecular mechanism.
Trial Length: 30 months
Trial Locations: This is a multicenter, worldwide study with 80 locations across the United States, United Kingdom, France, Canada, Australia, Czechia, Germany, Hong Kong, Spain, and Poland. Click here for a list of all participating locations.
Are you interested in participating?
You may be eligible to participate in this trial if:
You are 40 years and older with type 2 diabetes
You have been diagnosed with diabetic cardiomyopathy
You do NOT have an A1C greater than 8.5%
You do NOT have an ejection fraction of 40% or less on an echocardiogram
*Note: An echocardiogram is a heart exam that checks how your heart’s chambers and valves are pumping blood through the heart.
You do NOT have a prior diagnosis of Stage C or D heart failure
See a full list of inclusion/exclusion criteria here.
For more information, contact the Applied Therapeutics study team at [email protected] or call (+1) 212-220-9227.