For those who have diabetes, there might soon be a new option in town.
Clinical trials at the University of North Carolina (UNC) indicated injections of IDegLira were more effective than the current standard treatment of metformin and Lantus insulin.
Type 2 diabetes is a metabolic disease that occurs when insulin production drops, and the body's cells become less responsive to the effects of insulin. Insulin is the hormone that regulates blood sugar.
Most patients begin therapy with the oral medication metformin (brand name Glucophage). In many cases, injections of insulin are added. Even with this combined therapy, however, patients with type 2 diabetes often have trouble keeping their blood sugar under control.
“It’s quite remarkable that IDegLira can achieve such excellent control of diabetes in the toughest group of patients we treat," lead author John Buse, MD, PhD, said in a press release. "Without a doubt, if I were a diabetes patient, I’d consult with my doctor about using IDegLira instead of basal insulin.”
Dr. Buse is a professor of medicine at the UNC School of Medicine and director of the UNC Diabetes Care Center.
Dr. Buse and colleagues studied 557 patients who had type 2 diabetes. The patients were divided in two groups.
The first group was treated with glargine (brand name Lantus Insulin). The second group received IDegLira. Patients in both groups were also on metformin. The trial lasted 26 weeks.
The researchers measured patients' blood sugar levels with a lab test of glycated hemoglobin or HbA1c. This test shows the average blood sugar over a period of time and is a good indicator of whether the patient's blood sugar is under control.
Patients in the Lantus group had an average HbA1c of 8.2 percent at the beginning of the trial. Those in the IDegLira group had an average HbA1c of 8.4 percent.
In the Lantus group, the average HbA1c was 7.1 percent at the end of the trial. The average HbA1c in the IDegLira group was 6.6 percent at the end of the trial. A HbA1c below 7 percent is considered well-controlled.
People on IDegLira lost a little weight during the trial while those on Lantus gained a little weight.
Patients on IDegLira were more likely to report gastrointestinal side effects than those on Lantus. However, those on Lantus were more likely to have episodes of hypoglycemia (very low blood sugar).
IDegLira is under review by the US Food and Drug Administration are available only in Europe.
The study was published in the March issue of the Journal of the American Medical Association.
Study funding was provided by Novo Nordisk, which manufactures IDegLira.
Co-authors Lucine Lehmann, MD, and Mads Jeppe Tarp-Johansen work for Novo Nordisk.