| Victoza (Liraglutide) Side Effects (NN2211) approved by EU |
In November 2005, Denmark's Novo Nordisk, the world's biggest
maker of insulin, said that a phase II study showed promising safety
and efficacy results for their diabetes drug liraglutide. The study,
which was a double-blind, placebo-controlled, randomised,
monotherapy study over 14 weeks, included 165 patients with type 2
diabetes that were previously treated with diet or oral antidiabetic
agents.
In July, 2009, The European Commission has given market
authorization for the company's Victoza in the 27 European Union
member states. Victoza (generic name- Liraglutide) belongs to a
relatively new kind of diabetes drug class known as GLP-1
analogues. In contrast to conventional treatment with insulin, the
drug doesn't risk pushing blood glucose dangerously low and it also
helps patients to lose weight. [3]
WHAT IS VICTOZA (LIRAGLUTIDE)? Victoza is a once-daily, fully-
human GLP-1 analogue. The compound decreases the level of the
anti-insulin hormone glucagon. Furthermore, the potential effect of
GLP-1 on appetite regulation is being studied. During preclinical
testing, Liraglutide (NN2211) increased the ß-cell mass in animal
models of type 2 diabetes leading to speculations about its potential
ß-cell regeneration capacity.
ABOUT GLP-1 GLP-1 lowers blood glucose in type 2 diabetes patients
with the unique advantage that glucose-lowering ceases when blood
glucose gets into the normal range, as both effects on insulin and
glucagon release are glucose-dependent. Thus, it is possible to treat
effectively without simultaneously running a risk of inducing
hypoglycaemia, and at the same time improve the patient's ability to
manage weight, a very important problem during current treatment
of type 2 diabetes.
The development compound, Liraglutide (NN2211) is a derivative of
GLP-1 designed to be protected against DPPIV degradation and
elimination by the kidneys resulting in a prolonged half-life and thus
sustained action. This is primarily due to its binding to serum albumin.
Pre-clinical experiments (in mouse, rat and pig) and recently phase 1
data in both volunteers and type 2 diabetic patients have
demonstrated that the compound is suited for administration once a
day. The pharmacokinetic half-life in man is thus around 12 hours and
effects on blood glucose persists for 24 hours following one injection.
Thus, scientists at Novo Nordisk expect that Liraglutide (NN2211) will
exhibit all of the effects of native GLP-1, but in addition will offer a
very simple and convenient dose regime of once a day injection.
WHAT ARE ADVANTAGES OF LIRAGLUTIDE FOUND IN THE
STUDY? An improvement of haemoglobinA1c (HbA1c) of between 1.5
and 2 percentage points was achieved by treatment with liraglutide
compared to placebo. At the highest dose more than 45% of patients
achieved a target of HbA1c equal to or below 7% compared to less
than 8% treated with placebo. An HbA1c level below 7% is
recommended by the American Diabetes Association. The average
HbA1c level at the beginning of the study was just below 8.5%.
At the highest liraglutide dose, the improvement in fasting plasma
glucose achieved was above 3 mM (greater than 54 mg/dl). In
addition, these patients reduced their bodyweight by approximately
3 kg from a baseline of around 90 kg.
Novo Nordisk Chief Scientific Officer Mads Krogsgaard Thomsen said
the drug should gain a strong position on the market for diabetes
treatment since it has proven in tests to be more efficient compared
both with conventional insulin treatment and with Eli Lilly & Co's (LLY)
and Amylin Pharmaceutical's (AMLN) competing GLP-1 analogue,
Byetta. [3]
ARE THERE ANY SIDE EFFECTS OF LIRAGLUTIDE OBSERVED IN
PHASE IIB STUDY? Liraglutide was found to be well tolerated and
nausea was reported at a level of 5-10%. Gastrointestinal side
effects occurred most frequently in the beginning of the study, where
after the frequency decreased substantially. There were no cases of
major or minor hypoglycaemia in spite of the significant improvement
in glycaemic control.
HOME
Source: Promising Clinical Results from Liraglutide Phase 2b Study Novo
Nordisk A/S Press Release, November 25, 2005 AMERICAN JOURNAL OF
KIDNEY DISEASES 2001, Vol. 38, pg. 1376-1380 AMERICAN JOURNAL OF
CLINICAL NUTRITION 2002, Vol. 75, pg. P174. Novo Nordisk Online
Publications December 2, 2005 [3] UPDATE: Novo Nordisk Diabetes Drug
Victoza Gets EU Approval The Wall Street Journal JULY 3, 2009, 6:31 A.M. ET
maker of insulin, said that a phase II study showed promising safety
and efficacy results for their diabetes drug liraglutide. The study,
which was a double-blind, placebo-controlled, randomised,
monotherapy study over 14 weeks, included 165 patients with type 2
diabetes that were previously treated with diet or oral antidiabetic
agents.
In July, 2009, The European Commission has given market
authorization for the company's Victoza in the 27 European Union
member states. Victoza (generic name- Liraglutide) belongs to a
relatively new kind of diabetes drug class known as GLP-1
analogues. In contrast to conventional treatment with insulin, the
drug doesn't risk pushing blood glucose dangerously low and it also
helps patients to lose weight. [3]
WHAT IS VICTOZA (LIRAGLUTIDE)? Victoza is a once-daily, fully-
human GLP-1 analogue. The compound decreases the level of the
anti-insulin hormone glucagon. Furthermore, the potential effect of
GLP-1 on appetite regulation is being studied. During preclinical
testing, Liraglutide (NN2211) increased the ß-cell mass in animal
models of type 2 diabetes leading to speculations about its potential
ß-cell regeneration capacity.
ABOUT GLP-1 GLP-1 lowers blood glucose in type 2 diabetes patients
with the unique advantage that glucose-lowering ceases when blood
glucose gets into the normal range, as both effects on insulin and
glucagon release are glucose-dependent. Thus, it is possible to treat
effectively without simultaneously running a risk of inducing
hypoglycaemia, and at the same time improve the patient's ability to
manage weight, a very important problem during current treatment
of type 2 diabetes.
The development compound, Liraglutide (NN2211) is a derivative of
GLP-1 designed to be protected against DPPIV degradation and
elimination by the kidneys resulting in a prolonged half-life and thus
sustained action. This is primarily due to its binding to serum albumin.
Pre-clinical experiments (in mouse, rat and pig) and recently phase 1
data in both volunteers and type 2 diabetic patients have
demonstrated that the compound is suited for administration once a
day. The pharmacokinetic half-life in man is thus around 12 hours and
effects on blood glucose persists for 24 hours following one injection.
Thus, scientists at Novo Nordisk expect that Liraglutide (NN2211) will
exhibit all of the effects of native GLP-1, but in addition will offer a
very simple and convenient dose regime of once a day injection.
WHAT ARE ADVANTAGES OF LIRAGLUTIDE FOUND IN THE
STUDY? An improvement of haemoglobinA1c (HbA1c) of between 1.5
and 2 percentage points was achieved by treatment with liraglutide
compared to placebo. At the highest dose more than 45% of patients
achieved a target of HbA1c equal to or below 7% compared to less
than 8% treated with placebo. An HbA1c level below 7% is
recommended by the American Diabetes Association. The average
HbA1c level at the beginning of the study was just below 8.5%.
At the highest liraglutide dose, the improvement in fasting plasma
glucose achieved was above 3 mM (greater than 54 mg/dl). In
addition, these patients reduced their bodyweight by approximately
3 kg from a baseline of around 90 kg.
Novo Nordisk Chief Scientific Officer Mads Krogsgaard Thomsen said
the drug should gain a strong position on the market for diabetes
treatment since it has proven in tests to be more efficient compared
both with conventional insulin treatment and with Eli Lilly & Co's (LLY)
and Amylin Pharmaceutical's (AMLN) competing GLP-1 analogue,
Byetta. [3]
ARE THERE ANY SIDE EFFECTS OF LIRAGLUTIDE OBSERVED IN
PHASE IIB STUDY? Liraglutide was found to be well tolerated and
nausea was reported at a level of 5-10%. Gastrointestinal side
effects occurred most frequently in the beginning of the study, where
after the frequency decreased substantially. There were no cases of
major or minor hypoglycaemia in spite of the significant improvement
in glycaemic control.
HOME
Source: Promising Clinical Results from Liraglutide Phase 2b Study Novo
Nordisk A/S Press Release, November 25, 2005 AMERICAN JOURNAL OF
KIDNEY DISEASES 2001, Vol. 38, pg. 1376-1380 AMERICAN JOURNAL OF
CLINICAL NUTRITION 2002, Vol. 75, pg. P174. Novo Nordisk Online
Publications December 2, 2005 [3] UPDATE: Novo Nordisk Diabetes Drug
Victoza Gets EU Approval The Wall Street Journal JULY 3, 2009, 6:31 A.M. ET
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