written by Michael O’Leary
Daily injections of liraglutide (Victoza) nosed out once-a-week injections of exenatide (Bydureon) in a head-to-head comparison in terms of reducing HbA1c, but type 2 diabetes patients using exenatide experienced fewer, milder side effects.
The results of the clinical trial were presented last week at the 47th Annual meeting of the European Association for the Study of Diabetes last week in Lisbon, Portugal and was reported on by MedPage Today.
The DURATION-6 clinical trial involved 911 people with type 2 diabetes and was designed as what researchers call a noninferiority trail, in which the objective is to determine if a new drug is at least as effective as an already approved drug. In this case exenatide developers Eli Lilly, Alkermes, and Amylin Pharmaceuticals hoped to show that their once-a-week drug BYDUREON would be equal to Victoza in patients with type 2 diabetes who have not been able to achieve adequate control of their blood glucose with oral medications.
Patients taking BYDUREON reduced their HbA1c by an average of 1.26 percent compared to an average reduction of 1.48 percent for those taking Victoza. Earlier trials of BYDUREON had shown HbA1c reductions in the range of 1.5 percent to 1.9 percent.
Dr. John Buse, chief of the division of endocrinology and metabolism at the University of North Carolina in Chapel Hill, presented the results at the meeting. He noted that more patients taking Victoza experienced intestinal side effects compared to those taking BYDUREON.
Of the 450 patients taking Victoza, 20 percent complained of nausea compared to 9 percent of the 461 patients taking BYDUREON. Similarly 13 percent of those taking Victoza experienced diarrhea compared to 6 percent of those taking BYDUREON and about 11 percent of the Victoza group had vomiting compared to about 4 percent of those taking BYDUREON.
The results were disappointing to the drug companies seeking FDA approval of the more convenient once-weekly BYDUREON (by-DUR-ee-on), not that this trial alone will bar its approval.
Exenatide, the active ingredient in BYETTA, was a first-in-class GLP-1 receptor agonist. GLP-1 stimulates the release of insulin when glucose levels become too high. BYDUREON combines exenatide, with a technology developed by Alkermes, Inc to provide a sustained release delivery of the drug, which allows once-a-week injections. The drug can be taken alone or with other diabetes medications.