[acb-diabetics] new long acting insulin

Sat Apr 28 14:24:35 EDT 2012

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This article originally posted 26 April, 2012 and appeared in
<http://www.diabetesincontrol.com/topics/medication> Medication,
<http://www.diabetesincontrol.com/topics/type-2-diabetes> Type 2 Diabetes,
<http://www.diabetesincontrol.com/topics/type-1-diabetes> Type 1 Diabetes,
<http://www.diabetesincontrol.com/diabetes-in-control-newsletters/623> Issue
623 

Ultra-Long-Acting Insulin Degludec, Two New Studies

Two published Phase III studies reveal that ultra-long-acting insulin
degludec considerably reduced rates of....

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Two published Phase III studies reveal that ultra-long-acting insulin
degludec considerably reduced rates of nocturnal hypoglycemia in patients
with type 1 and type 2 diabetes by 25%, compared to insulin glargine.

"Hypoglycemia is a major concern for both people with diabetes and their
physicians and can often lead to under- and sub-optimal treatment," said
Alan Garber, MD, Professor, Departments of Medicine, Baylor College of
Medicine, Houston, Texas and lead author of one of the published papers in
The Lancet. "Of particular concern are hypoglycemic events that occur in the
overnight hours during sleep when patients are unaware and therefore unable
to take measures to reverse it. Newer insulins such as insulin degludec may
be able to mitigate this concern."

1,635 individuals with diabetes were enrolled to participate in the trials
in order to examine insulin degludec, compared to insulin glargine, in a
basal-bolus regimen. 

In both studies, researchers adjusted patient insulin doses systematically
in order to allow them to achieve a targeted fasting glucose level. Due to
this, participants in both studies successfully achieved similar
improvements in sugar control. This allowed the researchers to closely
determine disparity in hypoglycemia rates. 

Dr. Garber, stated that, the studies found that participants with type 2
diabetes who took insulin degludec had a considerably lower rate of overall
hypoglycemic events (11.1 episodes/patient-year), compared to individuals
assigned to insulin glargine (13.6). This figure was similar between both
groups in individuals with type 1 diabetes. 

Furthermore, results showed that insulin degludec reduced nocturnal
hypoglycemia by 25% in both type 1 and type 2 diabetes (4.4 vs. 5.9
episodes/patient-year), compared to participants taking insulin glargine
(1.4 vs. 1.8).

Insulin degludec is an ultra-long-acting basal insulin analogue discovered
and developed by Novo Nordisk. Insulin degludec has a distinct slow
absorption which provides a flat and stable action profile. Insulin degludec
has been studied in a large-scale clinical trial program, BEGINT, examining
its impact on glucose control, hypoglycemia and the possibility to flexibly
adjust insulin degludec dosing time to suit patient needs. Insulin degludec
has been submitted for once-daily use to the European Medicines Agency (EMA)
and the US Food and Drug Administration (FDA) in September 2011 for
regulatory review. In addition, insulin degludec has been submitted for
regulatory approval in Japan, Canada and Switzerland.

The Lancet. 2012; 379, pp 1489-97: "Insulin degludec, an ultra-long acting
basal insulin, versus insulin glargine in basal-bolus treatment with
mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a
phase 3, randomized, open-label, treat-to-target non-inferiority trial" 

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