This trial is examining the effect of different doses of efpeglenatide on reducing cardiovascular (CV) disease in patients with type 2 diabetes (T2D). The main outcome to be measured is the occurrence of heart attacks, strokes or death from either of these events.
The details
Patients with type 2 diabetes (T2D) have a high risk of CV disease (heart and blood vessel disease). Excess sugar in the blood gets deposited in the blood vessels and heart, causing damage to both these structures. This can cause CV events such as heart attacks and strokes, which may result in death. Efpeglenatide is a GLP-1 agonist used to treat T2D. Some GLP-1 agonists have shown to be effective in reducing heart disease in T2D. However, some have not. Therefore, it is important each drug is tested separately to establish its effects on CV health in T2D.
This study will investigate the effects of two different doses of efpeglenatide on the heart and blood vessels in patients with T2D. The main outcome to be measured will be the time to the first occurrence of either a heart attack, a stroke or death due to CV disease.
Who are they looking for?
This study is looking to recruit 4000 patients with T2D. Patients should be 18 years or older with diagnosed CV disease or older than 50 years (males)/older than 55 years (female). Participants should also have an estimated glomerular filtration rate or eGFR (a measurement of kidney function) of 25 mL/min or higher but less than 60 mL/min and at least one cardiovascular risk factor. Female patients must agree to follow contraceptive guidance and signed written informed consent must be given.
Patients should not have any diseases of the stomach and intestines associated with long-term nausea and vomiting. They should not have had any pancreatitis in 3 months prior to screening, no personal or family history of medullary thyroid cancer, no hospitalization due to high blood pressure in previous 3 months or have any planned heart surgery. Patients are not eligible if they have not had an eye examination in the past 6 months or if their anti-diabetic drug treatment has not been stable for the past 3 months.
How will it work
Patients will be divided into 3 groups. Group 1 will receive dose 1 of efpeglenatide weekly, group 2 will receive dose 2 of efpeglenatide once weekly and group 3 will receive a placebo once weekly. The drug will be administered by subcutaneous (under the skin) injection. The time to a CV event (heart attack or stroke) or death from a CV event will be measured. The time to a change in kidney function will also be recorded, along with any side effects. Patients will be followed for up to 3 years.
