This trial is examining the safety and effectiveness of efpeglenatide versus dulaglutide in patients with poorly controlled type 2 diabetes (T2D) who are on metformin. The main outcome to be measured will be a change in HbA1c (blood test measuring average blood glucose over the past 3 months). This trial is being conducted in the United States.
The details
There are many different treatment options for T2D. Metformin is usually the first drug used to try to control blood glucose. If blood glucose is still not adequately controlled with metformin, there are other drugs that can be added to the treatment regime. GLP-1 agonists are drugs that cause the body to release more insulin (the hormone that controls blood glucose). Dulaglutide is an effective GLP-1 agonist that is currently on the market. Efpeglenatide is a new GLP-1 that is being developed. Its safety and effectiveness in the treatment of T2D are unknown.
The aim of this study is to compare the safety and effectiveness of Efpeglenatide in comparison to dulaglutide in patients whose T2D is poorly controlled with metformin. The main outcome to be measured will be a change in HbA1c.
Who are they looking for?
This study is recruiting 900 patients. Patients must have been diagnosed with T2D at least 1-year before screening and be on a stable dose of metformin.
Patients must not have any bowel or stomach diseases associated with nausea and vomiting. Patients must not have a personal or family history of thyroid cancer or have a change in body weight of more than 5kg in the last 3 months. Patients must not have a blood pressure of greater than 180/100 mmHg. Female of childbearing age must be willing to take a pregnancy test before treatment and be willing to use birth control for the duration of the study. Patients should have adequate liver function tests.
How will it work
Patients will be randomized into two groups. One group will receive a weekly injection of Efpeglenatide. The other group will receive a weekly injection of dulaglutide. Patients will be treated for 56 weeks. Change in HbA1c levels will be measured. Other outcomes to be measured will be changes in body weight, the number of side effects experienced and of hypoglycaemic episodes (blood glucose going too low) experienced.
