June 27, 2011 (San Diego) -- The experimental, ultra-long-acting insulin degludec substantially reduces the risk of dangerously low blood sugar in people with diabetes, compared with the most widely prescribed long-acting insulin, Lantus, studies show.
Results from two year-long phase III trials pitting the two drugs against one another in people with type 1 and type 2 diabetes were presented here at the annual meeting of the American Diabetes Association.
Degludec is an ultra-long-acting insulin that remains active in the body much longer than insulin drugs already on the market. The trials were funded by its manufacturer, Novo Nordisk. Lantus (glargine) is manufactured by Sanofi-Aventis.
In the trials, daily injections of degludec were associated with similar blood sugar control to daily injections of Lantus, as measured by hemoglobin A1c (HbA1c) levels. Patients in both groups also took a mealtime insulin. Many also took oral metformin and/or Actos.
Treating Nighttime Hypoglycemia
The first trial included 992 patients with type 2 diabetes with high blood sugar (average HbA1c level of 8.3%), even though they were taking oral drugs to lower their blood sugar.
An HbA1c level of 7% or lower had been the traditional target for diabetes patients, but aggressive treatment to reduce levels to below 6% has been linked to an increased risk of death in people who also have risk factors for heart attack and stroke.
By one year later, about half of patients on both degludec and Lantus had reached target blood sugar levels, with A1c levels of less than 7%.
Rates of nighttime hypoglycemia, which occurs during sleeping hours, were 25% lower in those that took degludec compared with those on Lantus (1.4 vs 1.8 episodes per patient each year). People on degludec also had 18% fewer hypoglycemic episodes at any time of day (11.1 vs 13.6 episodes per patient per year for Lantus).
Also, patients on degludec tended to score higher on a standardized quality-of-life test measuring physical, social, and mental functioning.
"We were especially surprised that patients taking degludec reported significantly less body pain," researcher Alan J. Garber, MD, of Baylor College of Medicine in Houston, tells WebMD. He has served as a consultant for Novo Nordisk and received grants from Novo Nordisk and Sanofi-Aventis.
Treating Patients With Type1 Diabetes
By one year, about 40% of both groups reached the blood sugar target.
Rates of nighttime hypoglycemia were again 25% lower in the degludec group. Overall rates of low blood sugar were similar in the two groups.
Nocturnal hypoglycemia is "is a big issue for some patients and their families," says researcher Simon Heller, MD, of the University of Sheffield, England.
Degludec was generally well tolerated in both studies, with 4% of patients stopping its use due to side effects. Common side effects that affected more than 5% of patients included flu-like symptoms, respiratory tract infections, headaches, and diarrhea.
Asked to comment on the research for WebMD, session moderator Ira B. Hirsch, MD, of the University of Washington School of Medicine in Seattle, notes that "study after study at the meeting consistently show" that degludec is associated with fewer episodes of dangerously low blood sugar than current insulin drugs.
"Hypoglycemia is the limiting step with insulin therapy," he says.
Novo Nordisk plans to seek approval later this year to market the long-acting insulin in the U.S., according to a company spokesperson.
These findings were presented at a medical conference. They should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.