This phase 3 clinical trial is examining the safety and effectiveness of efpeglenatide for people with type 2 diabetes (T2D) that is not controlled with diet and exercise. The main outcome to be measured is change in HbA1c (measures average blood glucose over the last 3 months).
The details
People with T2D can control their symptoms, at first, with lifestyle changes (such as a healthy diet and exercise). However, most people will eventually need some medication to maintain control. Efpeglenatide is a new once-weekly injectable glucagon-like peptide 1 receptor agonist (GLP1RA). Glucagon-like peptide 1 (GLP1) is made in the intestines and released after a meal. GLP-1 stimulates the release of insulin (the hormone that lowers blood glucose) and inhibits the release of glucagon (hormone that raises blood glucose). These hormonal changes control blood glucose levels. GLP1RAs are drugs that mimic the effects of GLP1.
This study will examine the effectiveness of efpeglenatide. The main outcome of the study will be measured as the change in HbA1c after 56 weeks of treatment.
Who are they looking for?
This study is looking to recruit 400 people with T2D, whose glucose levels have not been controlled by diet and exercise. Participants must 18 years or older. Their HbA1c levels must be between 7% and 10%.
Participants may not have had diseases of the stomach and intestines, such as reflux. They may not have had acute pancreatitis. They may not have had thyroid cancer, or have a family history of thyroid cancer. They may not gain more than 5 kg (11 lb) in the 3 months before the trial. They may not have abnormal blood tests for liver disease, anemia, white blood cells, platelets (blood cells involved in clotting), or enzymes from the pancreas. They may not have abused alcohol or drugs in the 6 months before starting the trial. Women in the study may not be pregnant or breast-feeding.
How will it work
The participants will randomly be divided into 4 groups. 3 groups will receive injections of efpeglenatide once a week. One group will receive a low dose, another will receive a middle dose, and the other will receive a high dose. The fourth group will receive an injection of a placebo (drug with no active effect), once a week. Participants will not know which drug they are receiving.
HbA1c level, fasting blood glucose (blood glucose level after a period without food or drink), and body weight will be measured at the start of the trial, and after 30 and 56 weeks of treatment. The participants will also measure their own blood glucose levels during this time. The number of participants who need to be treated for hypoglycemia during the study will be recorded.
