Study Shows the Drug Degludec Helps Diabetes Patients When Injected 3 Times a Week
By Salynn Boyles
WebMD Health News
Reviewed By Laura J. Martin, MD
March 9, 2011 -- An experimental, ultra-long-acting insulin given just three times a week proved as effective as daily insulin for controlling blood sugar in people with type 2 diabetes, researchers say.
Results from phase II trials of the drug degludec, funded by its manufacturer Novo Nordisk, are published in The Lancet.
Type 2 diabetes patients in the study who took degludec by injection three times a week had similar reductions in hemoglobin A1c (HbA1c) as patients who got daily injections of the most widely prescribed long-acting insulin, Lantus (glargine), manufactured by Sanofi-Aventis.
But patients who took daily injections of the experimental insulin experienced the fewest episodes of potentially dangerous low blood sugar, known medically as hypoglycemia.
Study researcher Bernard Zinman, MDCM, of the University of Toronto, says the significant reduction in hypoglycemia seen among patients who took daily degludec injections suggests a clear advantage for the drug and dosing schedule.
“This ‘proof of concept' phase II study showed that patients achieve good [blood sugar] control when degludec is given just three times a week,” he tells WebMD. “But if you ask if I would recommend that it be used this way, my answer would be no. I think it should be used daily to reduce the risk of hypoglycemia.”
Measuring Blood Sugar Levels
The phase II study included 245 type 2 diabetes patients with high blood sugar (HbA1c levels of between 7% and 11%), even though they were taking oral drugs to lower their blood sugar.
An HbA1c level of 7% or lower has 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.
The patients were randomly assigned to receive the oral drug metformin and one of three treatment regimens: degludec insulin once a day, degludec three times a week, or Lantus once a day. The study lasted 16 weeks.
At the end of treatment, blood sugar levels were similar for all treatment groups, with HbA1c ranging from 7.2% to 7.5%.
Rates of hypoglycemia were low in all treatment groups, but they were lowest in the patients who took degludec once a day.
Just 5% of these patients experienced symptomatic episodes of low blood sugar, compared to 13% of patients who took degludec three times a week or glargine once a day.
Dugludec vs. Lantus for Blood Sugar Control
Late last year, Novo Nordisk announced early results from two year-long trials comparing degludec and Lantus in patients with type 1 and type 2 diabetes.
Neither phase III trial included a three-day-a-week treatment arm.
As in the phase II studies, patients who took daily injections of the experimental insulin had similar reductions in blood sugar with fewer episodes of low blood sugar as patients who took Lantus.
Novo Nordisk spokeswoman Ambre Morley tells WebMD that the company plans to seek approval later this year to market the long-acting insulin in both the U.S. and Europe.
Diabetes researcher Yogish C. Kudva, MD, of the Mayo Clinic College of Medicine, says the new generation of long-acting insulins hold the promise of improving diabetes disease control and patient outcomes.
But he adds that patients and doctors should not lose sight of the fact that the same thing can be said for making positive changes in lifestyle.
“As treatments get more and more complicated, this simple message is getting lost,” he says. “But lifestyle changes like losing weight, eating well, and exercising can make a huge difference in diabetes control.”
Zinman, B. The Lancet, March 10, 2011.
Bernard Zinman, MDCM, FRCPS, professor of medicine, Samuel Lunefeld Research Institute, Mount Sinai Hospital, University of Toronto.
Yogish C. Kudva, MD, assistant professor of medicine, Mayo Clinic College of Medicine, Rochester, Minn.
Ambre Morley, associate director of product communications, Novo Nordisk Inc.
News release, The Lancet.
Novo Nordisk: ‘Degludec Significantly Reduces the Risk of Hypoglycemia During the Night Compared to Insulin Glargine in Two Long-Term Studies,' Dec. 22, 2010.
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