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Datum nieuwsfeit: 12-09-2005
Insulin Detemir kan gewichttoename minimaliseren bij type 2 diabetici door middel van insuline therapie, met name onder de te zware en obesitas patienten
( BW)(NOVO-NORDISK) Insulin Detemir Can Limit Weight Gain Associated
with Insulin Therapy in Type 2 Diabetes - Particularly among the
Overweight and Obese Patients
Business Editors/Health/Medical Writers/Healthcare Writers
ATHENS, Greece--(BUSINESS WIRE)--Sept. 12, 2005--New data
presented today at the EASD Annual Meeting by Professor Kjeld
Hermansen (Aarhus University Hospital, Denmark) suggest that the novel
long-acting insulin, insulin detemir (Novo Nordisk) can be used in
people with type 2 diabetes without causing weight gain of the degree
that typically accompanies this progression of therapy. Furthermore,
the more overweight a patient is before insulin therapy, the less
weight they will tend to gain if insulin detemir, rather than
conventional insulin, is chosen. This new finding is likely to be
welcomed by both healthcare providers and patients concerned about the
well-known side effect of weight gain with insulin therapy.
The clinical significance of increasing body weight
Professor Hermansen explained that while the initiation of insulin
therapy improves blood glucose control, patients who gain weight
considerably as a result of using insulin can undergo adverse changes
in their blood pressure and lipid profiles(1). In type 2 diabetes,
which is typically diagnosed from middle age onwards, insulin-induced
weight gain can be especially problematic because patients of this
type are often overweight already and further weight gain can be
substantial and occur rapidly.
In the pivotal, large-scale 'UKPDS' study(2) of type 2 diabetes,
people beginning insulin therapy averaged a weight gain of nearly 5kg
over the initial 3 years, and many gained considerably more than this.
"The prospect of gaining weight to this extent can often dissuade
people with type 2 diabetes from accepting the need for insulin, or
from adhering to their prescribed therapy," professor Hermansen says
while adding: "Quite apart from their cosmetic concerns, these people
risk incurring serious complications from their diabetes if they allow
blood glucose to remain inadequately controlled as a result of delayed
or insufficient insulin therapy."
More insulin detemir patients reached HbA1c < 7.0% without
hypoglycaemia
In the multinational, 24-week clinical trial, 475 patients with
type 2 diabetes poorly controlled by oral anti-diabetic drugs, such as
metformin and sulphonylureas were randomised into two groups to
receiving either insulin detemir or NPH insulin in addition to their
prior treatment. Insulin detemir is a bio-engineered molecule similar
to human insulin, but with slight modifications designed to give a
more prolonged and predictable blood glucose lowering action following
subcutaneous injection. The test insulins were given twice daily, and
doses were continuously adjusted to achieve the best levels of blood
glucose control possible. This was reflected in excellent improvements
in HbA1c values, which decreased from an average of approximately 8.6%
to less than 6.6% in both treatment groups over the study, with more
than 70% of patients achieving values of no more than 7.0%.
Although overall blood glucose control was similar in the two
groups, there were marked differences in tolerability. People treated
with insulin detemir benefited from a significantly lower incidence of
episodes of hypoglycaemia, with their overall and night-time risk
being half that seen with NPH insulin (relative risk reductions, 47%
and 55%, respectively, p <0.001, both endpoints). Furthermore,
significantly more recipients of insulin detemir achieved HbA1c levels
of no more than 7.0% without any hypoglycaemia (26% compared to 16%
with NPH insulin, p = 0.008).
Less weight gain among the overweight and obese patients
People treated with NPH insulin gained an average 2.8kg in weight
over 24 weeks, whereas those receiving insulin detemir gained just
1.2kg (p < 0.05). "When weight gain was assessed in terms of patients'
baseline body mass index (BMI), it became clear that overweight
recipients of insulin detemir were benefiting from relatively greater
reductions in weight gain" explained professor Hermansen. "In fact,
the more overweight a person was at baseline, the less weight they
would tend to gain, with clinically overweight and obese patients
gaining little more than 0.5 kg. In contrast, patients treated with
NPH insulin gained 2.5-3.0 kg regardless of their BMI." Professor
Hermansen noted that this observation was not explained by treatment
differences in dose, blood glucose control or risk of hypoglycaemia.
The BMI related weight benefit also seen for basal-bolus therapy
Interestingly, other results broadly consistent with Hermansen's
will also be presented at poster display by Dr Katarina Raslova
(Bratislava, Slovak Republic - poster number 842) on 14th September.
Raslova and colleagues also assessed weight gain by baseline BMI in an
analysis of data from 900 patients with type 2 diabetes. However,
these data were pooled from two previous studies comparing insulin
detemir with NPH insulin in basal-bolus therapy; a form of treatment
usually reserved for patients with more advanced type 2 diabetes. At
equivalent levels of blood glucose control, patients receiving insulin
detemir gained just 0.42kg over 22-24 weeks, whereas patients treated
with NPH insulin gained 1.24 kg (p = 0.0005). There was a tendency for
weight gain to increase with baseline BMI in NPH insulin-treated
patients, but this effect was not seen with insulin detemir. Among the
most obese patients (BMI more than 35kg/m2) a slight weight loss
(-0.45 kg) was associated with insulin detemir in contrast to an
average gain of 2.4kg with NPH insulin.
In summary, all these new data suggest that:
-- Insulin detemir has a weight-sparing effect compared to
conventional basal insulin when used either as the initial
insulin therapy for type 2 diabetes (added to oral
anti-diabetic drug therapy), or as the basal component of more
intensified insulin-only therapy.
-- This advantage is preserved even when the insulin dose is
upwardly adjusted to the point where most patients achieve
guideline target levels of blood glucose.
-- The advantage is especially pronounced in patients who are
already overweight or obese.
Insulin detemir is a long-acting insulin analogue used as basal
insulin, in combination with meal-related short- or rapid-acting
insulin.
Insulin detemir is indicated for treatment of diabetes mellitus
for adults and children 6 years or older.
Notes to editors:
Novo Nordisk is a healthcare company and a world leader in
diabetes care. The company has the broadest diabetes product portfolio
in the industry, including the most advanced products within the area
of insulin delivery systems.
In addition, Novo Nordisk has a leading position within areas such
as haemostasis management, growth hormone therapy and hormone
replacement therapy. Novo Nordisk manufactures and markets
pharmaceutical products and services that make a significant
difference to patients, the medical profession and society.
With headquarters in Denmark, Novo Nordisk employs approximately
21,200 full-time employees in 78 countries, and markets its products
in 179 countries. Novo Nordisk's B shares are listed on the stock
exchanges in Copenhagen and London. Its ADRs are listed on the New
York Stock Exchange under the symbol 'NVO'. For more information,
visit novonordisk.com.
References:
1 Purnell. JAMA 1998;280:140-6.
2 United Kingdom Prospective Diabetes Study group report 34.
Lancet 1998;352:854-65.
--30--SM/uk*
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