new long acting insulin

April 28, 2012

sue-new-hyperglycemia-management-guidelines>

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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