Liraglutide – Next-Generation Antidiabetic Medication{Liraglutide
دواء مضاد لمرض السكر من الجيل التالي}
Under development by Novo
Nordisk, liraglutide is a member of a new class of antidiabetic medications
called GLP-1 analo
Drug (Brand/Generic)
Liraglutide
Company/Licensee
Novo Nordisk
Therapy Class
GLP-1 analogue
Product Description
Long-acting human analogue of naturally occurring hormone, GLP-1
Current Indication
Type 2 diabetic patients poorly controlled with diet plus metformin and/or
sulfonylureas
Expand
Novo Nordisk’s repaglinide (NovoNorm) is an oral antidiabetic agent for the
treatment of type 2 diabetes in patients who uncontrolled by diet and exercise.
Raised blood pressure and obesity are features
{تحت التطوير من قبل شركة Novo Nordisk ، فإن liraglutide هو عضو في فئة جديدة من الأدوية المضادة لمرض السكر تسمى GLP-1 analo
عقار (ماركة / عامة)
ليراجلوتايد
الشركة / المرخص له
نوفو نورديسك
فئة العلاج
نظير GLP-1
وصف المنتج
التناظرية البشرية طويلة المفعول للهرمون الطبيعي GLP-1
الإشارة الحالية
مرضى السكري من النوع 2 سيطرت عليهم الحمية الغذائية بالإضافة إلى الميتفورمين و / أو السلفونيل يوريا
يوسع
ريباجلينيد نوفو نورديسك (نوفونورم) هو عامل مضاد لمرض السكر عن طريق الفم لعلاج مرض السكري من النوع 2 في المرضى الذين لا يخضعون للسيطرة عن طريق النظام الغذائي والتمارين الرياضية.
ارتفاع ضغط الدم والسمنة من السمات}
common to people who develop
type 2 diabetes.
Novo Nordisk’s NovoMix 30 is a unique insulin analogue that combines rapid
and intermediate acting insulin aspart, providing the insulin requirement in a
single injection.
Novo Nordisk’s repaglinide (NovoNorm) is an oral antidiabetic agent for the
treatment of type 2 diabetes in patients who uncontrolled by diet and exercise.
Raised blood pressure and obesity are features common to people who develop
type 2 diabetes.
Liraglutide is an antidiabetic drug manufactured by Novo Nordisk. It is a
member of a new class of antidiabetic medications called GLP-1 analogues. These
mirror the effects of naturally produced glucagon-like peptide-1 (GLP-1), which
includes glucose-dependent stimulation of insulin secretion, suppression of
glucagon secretion, reduction of appetite and delay of food absorption
{شائع للأشخاص الذين يصابون بداء السكري من النوع 2.
NovoMix 30 من Novo Nordisk هو نظير فريد للأنسولين يجمع بين الأنسولين السريع والمتوسط المفعول الأسبارت ، مما يوفر متطلبات الأنسولين في حقنة واحدة.
ريباجلينيد نوفو نورديسك (نوفونورم) هو عامل مضاد لمرض السكر عن طريق الفم لعلاج مرض السكري من النوع 2 في المرضى الذين لا يخضعون للسيطرة عن طريق النظام الغذائي والتمارين الرياضية.
يُعد ارتفاع ضغط الدم والسمنة من السمات الشائعة للأشخاص المصابين بداء السكري من النوع 2.
Liraglutide هو دواء مضاد لمرض السكر تصنعه شركة Novo Nordisk. إنه عضو في فئة جديدة من الأدوية المضادة لمرض السكر تسمى نظائر GLP-1. تعكس هذه تأثيرات الببتيد 1 الذي يشبه الجلوكاجون الطبيعي (GLP-1) ، والذي يتضمن التحفيز المعتمد على الجلوكوز لإفراز الأنسولين ، وقمع إفراز الجلوكاجون ، وتقليل الشهية وتأخير امتصاص الطعام}
Based primarily on data from the LEAD Phase III trials, in May 2008 the company
submitted a New Drug Application (NDA) to regulatory authorities in the US and
Europe. Somewhat earlier than expected, filling subsequently followed in Japan
in July 2008.
In April 2009, a US Food and Drug Administration (FDA) advisory committee
reviewed data from animal studies and expressed concerns that the drug may
cause thyroid tumours in mice and rats.
Although there was no evidence that liraglutide caused cancer in humans, the committee
was of the opinion that Novo Nordisk had not ruled out the possibility. The
timing of liraglutide’s launch in the US depended on the completion of the
FDA’s review of Novo Nordisk’s NDA.
"In January 2010, the FDA approved Victoza for the treatment of type 2
diabetes in adults."
However, in July 2009, the European Commission awarded marketing authorisation
for Victoza (liraglutide) in 27 member countries of the EU. Victoza is the
approved brand name for liraglutide in Europe. The authorisation governed
treatment in combination with metformin or a sulphonylurea in patients with
inadequate glycaemic control in spite of maximal tolerated dose of monotherapy
with these agents. The authorisation also covered combination treatment with
metformin and a sulphonylurea or metformin and a thiazolidinedione in patients
with inadequate glycaemic control in spite of the therapies.
Following the authorisation Novo Nordisk launched Victoza onto the UK, Germany
and Denmark markets. The company launched Victoza in other European markets
throughout 2009 and 2010.
In January 2010, the FDA approved Victoza for the treatment of type 2 diabetes
in adults. The drug has been approved as an auxiliary treatment to diet and
exercise to enhance glycaemic control in adults suffering from type 2 diabetes.
The approval enables the drug to be used as a monotherapy, as a second-line
treatment and also in combination with other oral medications prescribed for
diabetes. Victoza became commercially available in the US market within three weeks
of approval in February 2010.
Victoza was also approved in Japan by the Japanese Ministry of Health, Labour
and Welfare in January 2010. Following the approval, Victoza became the first
GLP-1 to be approved in Japan. The approval granted the use of Victoza as a
monotherapy or in combination with sulphonylurea in adults suffering with type
2 diabetes. Novo Nordisk launched the drug in Japan in June 2010 after
completion of price negotiations and listing on Japan’s National Health
Insurance price list.
The growing burden of type 2 diabetes
Estimates from the World Health Organization indicate that worldwide more than
170 million people have diabetes, of which type 2 diabetes accounts for about
90% of all cases. Prevalence is predicted to continue growing, fuelled in
particular by rising rates of obesity, which is a major risk factor for
impaired glucose tolerance leading to type 2 diabetes.
"GLP-1 analogues should carry a much lower risk of hypoglycaemia than many
established antidiabetic medications."
Although there have been important advances in the development of new therapies
for type 2 diabetes, there remains a need for safe and effective antidiabetic
medications. Currently available antidiabetic agents that boost insulin
secretion or heighten insulin sensitivity can lead to patients developing
extremely low blood glucose levels, or hypoglycaemia.
Because GLP-1 analogues act to lower blood glucose only when levels are raised
and not during periods of normal or low blood-glucose concentrations, they should
carry a much lower risk of hypoglycaemia than many established antidiabetic
medications.
"LEAD" clinical trials demonstrate efficacy
The clinical effectiveness of Novo Nordisk’s liraglutide was evaluated in a
series of clinical trials as part of the Liraglutide Effect and Action in
Diabetes, or LEAD programme, which consisted of a series of randomised,
double-blind controlled studies. These trials assessed the clinical
effectiveness of liraglutide in some 3,800 patients with type 2 diabetes whose
blood glucose is inadequately controlled with standard oral therapies.
The release of data from three of these major phase III studies suggested that
the addition of liraglutide to ongoing oral antidiabetic drugs can
significantly improve glycaemic control in previously uncontrolled type 2
diabetics.
In LEAD 1, a trial in which 1026 patients receiving maximal dose glimepiride
were subsequently randomised to treatment with liraglutide, rosiglitazone or
placebo, liraglutide achieved statistically significantly better glucose
control (HbA1c <7%) than rosiglitazone.
In LEAD 2, in which 1026 patients receiving maximal dose metformin were
subsequently randomised to treatment with liraglutide, glimepiride or placebo,
the improvement in HbA1c was similar in the liraglutide and glimepiride
treatment arms.
In LEAD 5, a 581-patient study, the addition of liraglutide to metformin and
glimepiride saw over 50% of patients achieving good glycaemic control (HbA1c
<7%) with over 35% an HbA1c of <6.5%. The reduction in HbA1c achieved
with liraglutide was >0.2% better than that achieved in the active
comparator arm (insulin glargine), a statistically significant difference.
Data from the LEAD 6 trial showed that liraglutide was significantly more
effective at improving glycaemic control in patients with type 2 diabetes than
exenatide, a GLP-1 mimetic administered twice daily. In this 376-patient study,
patients were assigned 26-weeks’ treatment with either exenatide or
liraglutide. At the end of this period, patients on exenatide were switched to
liraglutide. Statistically significant improvements were seen with respect to
reductions in HbA1c, fasting plasma glucose and blood pressure.
These findings suggest that treatment with liraglutide is at least as good if
not better than standard antidiabetic therapies. Liraglutide was a well
tolerated agent, with nausea the most common treatment-emergent adverse event
to occur in the trials conducted to date.
GLP-1 analogues may aid weight loss in obese patients
Data from the LEAD clinical trials programme showed that in type 2 diabetic
patients, treatment with liraglutide leads to significant weight loss.
"Liraglutide was a well-tolerated agent, with nausea the most common
treatment-emergent adverse event to occur in the trials conducted to date."
At the end of the LEAD studies, the difference in body weight between
liraglutide and insulin glargine was on average 3.5kg, and 2kg and 4kg in
comparison with rosiglitazone and glimepiride respectively. These findings are
encouraging given that weight gain is a well recognised drawback of many
established antidiabetic medications.
The potential to extend the use of liraglutide beyond diabetes to the treatment
of obesity is clearly of interest, and supported by preclinical findings. In
animal studies, administration of liraglutide was found to have a profound and
persistent anorectic effect that resulted in weight loss.
If these findings are subsequently borne out in clinical trials in obesity then
the anorectic actions of liraglutide may prove important in aiding weight loss
not only in obese patients with type 2 diabetes but also in obese non-diabetic
patients.
Marketing commentary
At present type 2 diabetic patients poorly controlled with diet plus metformin
and/or sulfonylureas usually receive additional oral medications, to which
insulin is sometimes added, or insulin therapy alone. GLP-1 analogues offer an
alternative approach for this patient population.
Analysts believe that Novo Nordisk’s liraglutide will help expand the market
for GLP-1 analogues and increase treatment choice for type 2 diabetic patients.
Byetta (exenatide), a drug with a similar mode of action to liraglutide, is
already on the market as a treatment for type 2 diabetics inadequately
controlled with standard therapies.
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