Investigational Ultra-long-acting Insulin Degludec Reduces Rates of Nocturnal Hypoglycaemia in Type 2 Diabetes Patients Versus Insulin Glargine

Informations

• Publié par: novo-nordisk
• Nombre de lectures: 11
• Langue: English

Extrait

Investigational Ultra-long-acting Insulin

Degludec Reduces Rates of Nocturnal

Hypoglycaemia in Type 2 Diabetes Patients

Versus Insulin Glargine

PR Newswire

PHILADELPHIA, June 22, 2012

PHILADELPHIA

,

June 22, 2012

/PRNewswire/ --

Ultra-long-acting insulin degludec, an investigational insulin being developed by

Novo Nordisk, significantly reduced the rate of hypoglycaemia

[*]

at night in

adults with type 2 diabetes while obtaining equivalent improvement in glucose

control compared with insulin glargine over a 52-week period. This phase 3a

study was presented at the 72

nd

Scientific Sessions of the American Diabetes

Association (ADA).

[1]

The study also found that insulin degludec had significantly lower rates of

severe hypoglycaemia compared to insulin glargine.

[1]

"Nocturnal, or night-time, hypoglycaemia is a particular challenge for people

living with diabetes, as these episodes are often unpredictable and difficult to

detect", said Bernard Zinman, lead author and director of the diabetes centre

at Mount Sinai Hospital, and professor of medicine, University of Toronto.

This randomised, open-label, non-inferiority, treat-to-target trial compared

efficacy and safety of insulin degludec to insulin glargine. Both insulins were

given once-daily in 1,030 insulin-naïve type 2 diabetes adults inadequately

controlled with oral anti-diabetic medications.

Findings of the study include:

[

1]

Nocturnal hypoglycaemic rates were significantly lower by 36% with insulin degludec

than with insulin glargine (0.25 versus 0.39 episodes per patient per year;

p

=0.04).

Overall confirmed hypoglycaemic rates were 1.52 versus 1.85 episodes per patient per

year for insulin degludec and insulin glargine respectively (

p

=0.11).

Overall severe hypoglycaemia was infrequent in both treatment populations, but it was

significantly lower with insulin degludec than with insulin glargine (0.003 versus 0.023

episodes/patient-year;

p

=0.02).

At one year, this trial demonstrated comparable HbA

1c

reductions with insulin degludec

versus insulin glargine (-1.06% versus -1.19%).

Fasting plasma glucose (FPG) reductions were significantly greater with insulin

degludec than with insulin glargine (-67.7 versus -59.5 mg/dl, estimated treatment

difference (EDT) -7.7 mg/dl, p=0.005).

Overall adverse event rates were low and similar between groups.

[1]

[*]

Classified as low blood sugar occurring between 00:01 - 05:59 inclusive.

References

1. Zinman B,

et al.

The Effect of Insulin Degludec on Glycemic Control and

Nocturnal Hypoglycemia Compared with Insulin Glargine: A 1-year Randomized

Trial in Insulin-naive People with Type 2 Diabetes. Poster presented at the 72

nd

Scientific Sessions of the American Diabetes Association,

9 June 2012

. (NN1250-

3579)