Merck's Glucophage(R) SR Receives Label Extension for Patients at High Risk of Type 2 Diabetes in the UK
DARMSTADT, Germany, May 18, 2017 /PRNewswire=KYODO JBN/--
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Glucophage(R) SR offers UK healthcare professionals the first licensed
treatment option for overweight adult patients at high risk of progression to
type 2 diabetes, after failure of intensive lifestyle changes
Non-diabetic hyperglycemia, also known as impaired glucose regulation or
pre-diabetes, was estimated in 2009 to affect around seven million adults in
the UK and is predicted to significantly increase in the coming years
Merck, a leading science and technology company, today announced that the
Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has
authorized Glucophage(R) SR (sustained release formulation; metformin), for the
reduction in the risk or delay of the onset of type 2 diabetes in adult,
overweight patients with impaired glucose tolerance (IGT) and/or impaired
fasting glucose (IFG), and/or increased glycated hemoglobin (HbA1c), when
intensive lifestyle changes for 3 to 6 months have failed. This condition is
referred to by a variety of names in medical guidelines, i.e. as non-diabetic
hyperglycemia, as impaired glucose regulation, or as pre-diabetes.,-
Merck has already received authorization for this indication in several
countries around the world. Through earlier intervention, patients can reduce
their risk of developing type 2 diabetes as well as complications that can
lead to serious health issues.
"We are pleased that patients at risk of diabetes in the UK now have a
medicinal treatment option to help them delay the onset of diabetes, when
intensive lifestyle changes alone are not enough to work against the
progression to type 2 diabetes," said Luciano Rossetti MD, Executive Vice
President, Global Head of Research & Development at the biopharma business of
Merck: "According to WHO, diabetes is considered a global pandemic and we are
committed to helping slow the rapidly growing incidence. This is an important
achievement as it can help play a role in reducing the burden of type 2
diabetes for patients."
The authorization is based on clinical data on the efficacy of Glucophage(R)
for the treatment of non-diabetic hyperglycemia, primarily gathered in the
large US Diabetes Prevention Program (DPP) and subsequent Diabetes
Prevention Program Outcome Study (DPPOS)- with Glucophage(R). This data
was complemented by comprehensive safety and efficacy data on Glucophage(R)
collected since its first use in patients in 1957.
Non-diabetic hyperglycemia is triggered by insulin resistance, that causes
cells to be unable to effectively utilize insulin, which is needed to get the
glucose inside the cells and to stabilize blood glucose levels. This is also
called impaired glucose tolerance (IGT). As a response, more insulin may be
produced, which may again lose efficacy over time. Eventually, blood glucose
levels in the body rise to higher than normal values even between meals, which
is called impaired fasting glucose (IFG). Elevated blood glucose levels are
also often measured as an average over time through HbA1c. The corresponding
lab values for diagnosis of non-diabetic hyperglycemia as per UK's National
Institute for Health and Care Excellence (NICE) guidelines, are fasting glucose
between 100 and 125 mg/dl, and/or 140 to 199mg/dl in a glucose tolerance test,
and/or HbA1c between 6.0 and 6.4%.
From this stage of non-diabetic hyperglycemia, the disease may then further
slowly progress to overt type 2 diabetes. Intensive lifestyle changes will be
used as a first counter action. If the patient is still at high risk of
progression to type 2 diabetes after 3 to 6 months with worsening glycemic
control despite intensive lifestyle measures, Glucophage(R) SR is now an
additional treatment option that may help to slow the deterioration of the
blood glucose levels. Treatment with Glucophage(R) SR must be based on a risk
score incorporating appropriate measures of glycemic control and including
evidence of high cardiovascular risk. A benefit in the reduction of risk or
delay of the onset of type 2 diabetes has not yet been established in patients
75 years and older.
Glucophage(R) (metformin hydrochloride) is a prescription-only medicine
indicated for the treatment of type 2 diabetes mellitus, particularly in
overweight patients when diet and exercise alone have failed. In adults,
Glucophage(R) may be given alone or with oral antidiabetic agents, or with
insulin. The most commonly reported side effects with Glucophage(R) SR are
gastro-intestinal disturbances that may occur during treatment initiation and
resolve spontaneously in most cases.
The Glucophage(R) product portfolio comprises: Glucophage(R) IR (immediate
release formulation) and Glucophage(R) SR (sustained release formulation).
Outside of the UK, Glucophage(R) SR is known as Glucophage(R) XR (extended
release). In addition, Merck produces Glucovance(R) a fixed dose combination of
metformin and glibenclamide.
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and performance materials. Around 50,000 employees work to further develop
technologies that improve and enhance life - from biopharmaceutical therapies
to treat cancer or multiple sclerosis, cutting-edge systems for scientific
research and production, to liquid crystals for smartphones and LCD
televisions. In 2016, Merck generated sales of EUR 15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical
company. The founding family remains the majority owner of the publicly listed
corporate group. Merck holds the global rights to the Merck name and brand. The
only exceptions are the United States and Canada, where the company operates as
EMD Serono, MilliporeSigma and EMD Performance Materials.
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Published 12 July 2012. Available at:
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Diabetes Care 2013; 36(1):S11-66
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Cardiovascular Diseases. Available at:
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and cardiovascular diseases developed in collaboration with the EASD - Summary.
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11. DPP Research Group. Long-term Effects of Lifestyle Intervention or
Metformin on Diabetes Development and Microvascular Complications: the DPP
Outcomes Study. The Lancet Diabetes and Endocrinology 2015 3(11):866-875