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Medical Areas: Endocrinology | Family Medicine
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NovoLog (insulin aspart)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Novo Nordisk
Approval Status: Approved June 2000
Treatment Area: Diabetes Mellitus
Traditional regular human insulin requires people to inject
their insulin dosage 30 minutes before eating. NovoLog has faster
absorption, faster onset of action and shorter duration of action
than regular human insulin. The quick onset of blood sugar lowering
after injection of NovoLog allows people with diabetes to inject
themselves immediately before eating, offering flexibility to
The six-month, open-label trial randomized 884 patients with
type I diabetes to receive either human insulin thirty minutes
before meals or NovoLog immediately before meals. Study results
were presented at the American Diabetes Association annual meeting
in San Diego on June 22.
Prior to randomization, all subjects received a four-week
treatment regimen consisting of human insulin before meals and NPH
insulin as basal insulin. HbA1c levels and eight-point daily blood
glucose profiles were assessed at six months to evaluate
At six months, HbA1c was significantly lower (p=0.005) in the
insulin aspart group (7.8% ± 0.1) than the human insulin group
(7.9% ± 0.2).
Blood glucose levels also showed superior reduction at six
months in the insulin aspart group after breakfast, lunch and
dinner, and before lunch (156 ± 3, 137 ± 3, 153 ± 3, and 126 ± 3
mg/dL, respectively) when compared to the human insulin group (185
± 5, 162 ± 4, 168 ± 4, and 138 ± 4 mg/dL). The p-value for all
comparisons was less than 0.016.
In addition, the prandial blood glucose increments -- defined as
the mean of the differences between the blood glucose value 90
minutes after the meal and the blood glucose value just before the
meal -- were significantly lower (p = 0.0001) in the NovoLog group
(2.2 ± 2.2 mg/dL) than the human insulin group (28.4 ± 2.9 mg/dL),
the investigators said.
The safety profiles for the two products were similar, with low
frequencies of hypoglycemic episodes reported for both treatments.
While the overall risk of hypoglycemia was similar, the authors
noted that a smaller percentage of episodes occurred between
midnight and 6 a.m. in the NovoLog group (16% of episodes vs. 34%).
Hypoglycemia and hypokalemia, as well as lipodystrophy and
hypersensitivity, are among the potential clinical adverse effects
associated with the use of all insulins.
Clinical trials comparing NovoLog with regular human insulin did
not demonstrate a difference in adverse reaction frequency.
In controlled clinical trials, small, but evident elevations in
alkaline phosphatase were observed in some patients that were
treated with NovoLog. The clinical significance of this finding is
unknown at this time.
Mechanism of Action
The main function of NovoLog is the regulation of glucose
metabolism. Insulins bind to insulin receptors on both muscle and
fat cells and then lower blood glucose by facilitating the cellular
uptake of glucose and simultaneously preventing or slowing the
output of glucose from the liver.
In standard mice and rabbit testing, one unit of NovoLog has the
same glucose-lowering effect as one unit of regular human insulin.
In humans, the effect is more rapid and shorter in duration than
regular human insulin, due to NovoLog's faster absorption rate
As will all insulin preparations, the time course of NovoLog
action may vary in different individuals or at different times in
the same individual and is dependent on blood supply, injection
site, temperature, and physical activity.
NovoLog is sold as NovoRapid outside the US. Novo Nordisk
received marketing approval for NovoRapid from the European Union
last year, and it is now available in several European countries,
such as the United Kingdom and Germany. Other diabetes products
currently in development include premixed and long-acting insulin