(dailyRx News) Across the United States, people with type 2 Diabetes struggle to keep their blood sugar levels in check throughout the day. These patients soon may have a new drug option to help them out.
The drugmaker Sanofi has announced positive results from a study of its diabetes drug Lyxumia (lixisenatide). In combination with Lantus (insulin glargine), Lyxumia was shown to improve blood sugar levels and body weight in patients with type 2 diabetes.
Insulin is a hormone that the body needs in order to use glucose (sugar) as energy. In people with Type 2 Diabetes, the body either produces too little insulin or is resistant to insulin. Without insulin, glucose builds up in the blood instead of being used by cells, which can lead to a variety of diabetes-related complications.
Lyxumia is part of a class of drugs called GLP-1 agonists. These drugs work by triggering the release of insulin when blood sugar levels get too high.
In a study called the GetGoal Duo 1 study, researchers found that Lyxumia in combination with Lantus insulin treatment significantly reduced HbA1c levels (a measure of blood sugar over three months) in patients with type 2 diabetes. The combination treatment also improved post-prandial blood sugar levels, which could help patients avoid dangerous spikes in blood sugar after meals.
"This is another key milestone in the clinical development program for our new GLP-1 agonist," Pierre Chancel, Senior Vice-President of Sanofi Diabetes, said in a recent statement. "These positive results show that once-daily [Lyxumia] in combination with Lantus could be an innovative therapeutic option for the treatment of uncontrolled type 2 diabetes…."
For a randomized, double-blind, placebo-controlled study, researchers randomly assigned 446 type 2 diabetes patients to take either Lyxumia once a day or placebo for 24 weeks. All of the patients also received Lantus and Metformin, the first-line drug for diabetes treatment.
It is recommended that diabetes patients try to keep their HbA1c levels below seven percent. After being treated with Lyxumia, 56.3 percent of patients reached this target HbA1c level. In comparison, only 38.5 percent of those who took placebo reached the target.
Patients in the Lyxumia group also had improved body weight and two-hour post-prandial glucose levels (a measure of blood sugar two hours after a meal), compared to those in the placebo group.
The European Medicines Agency (EMA) has already accepted Sanofi's marketing authorization application. The company plans to submit for regulatory approval of Lyxumia sometime next year.
The full results of the GetGoal Duo 1 study are planned to be presented at a future medical meeting.