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.
But patients with type 1 and type 2 diabetes who took the experimental insulin experienced fewer episodes of nighttime low blood sugar. Low blood sugar is known medically as hypoglycemia.
Previous phase II research has shown that degludec given just three times a week is as effective as daily insulin for controlling blood sugar in people with type 2 diabetes.
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
The other study involved 629 people with type 1 diabetes and an average HbA1c level of 7.7% while on oral drugs to lower their blood sugar.
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