New NICE Guideline for Type 2 Diabetes Recognises Benefits From Newer Agents for Blood Glucose Control

London (ots/PRNewswire) -

- For Healthcare and Pharmaceutical Correspondents Only

- NICE Recommends Considering DPP-4 Inhibitors as a Second Line
Treatment Option in Appropriate Patients

Merck Sharp & Dohme Limited (MSD) welcomes the publication of the
guideline for type 2 diabetes newer agents1 from the National
Institute for Health and Clinical Excellence (NICE) in the UK, which
recommends considering a range of newer therapy options, including
'Januvia' (sitagliptin). The guideline recommends that the DPP-4
inhibitor class, which includes sitagliptin, should be considered as
a second line therapy instead of a sulphonylurea (SU) when blood
glucose control remains or becomes inadequate (HbA1c greater than or
equal to 6.5% or other higher level agreed with the individual) with
metformin in patients at significant risk of hypoglycaemia or its
consequences, or if a patient does not tolerate an SU or an SU is
contraindicated.(1)

Professor Anthony Barnett, a leading diabetologist from the UK
said, "One of the key issues when considering treatment options is
striking a balance between achieving optimal glycaemic control while
also minimising the risk of hypoglycaemia, and the newer treatments
provide us with a wider choice of options. NICE should be applauded
for recognising these newer agents, as this represents a significant
milestone in the treatment of type 2 diabetes and may have an impact
across the rest of Europe. We now have an array of effective
treatment options to offer appropriate patients whose blood glucose
is not adequately controlled by first-line treatments plus diet and
exercise, to help get their blood sugar under control in order to
carry on with their everyday lives."

It is estimated that there are over 53.2 million people in Europe
living with diabetes and that this figure is set to rise to 64.1
million by 2025.(2) A recent MSD Diabetes survey of healthcare
professionals (HCPs) across Europe found that the majority (78%) felt
that fewer prescribing restrictions would aid more effective disease
management.(3)

Some of the newer agents, such as the DPP-4 class, have a lower
risk of hypoglycaemia and weight gain. As highlighted within the NICE
guideline, the latest data on the DPP-4 inhibitor sitagliptin has
shown that treatment with sitagliptin was associated with fewer
hypoglycaemic events compared to treatment with metformin and
glipizide, a sulphonylurea, 5% versus 32% respectively.(4) When added
to a sulfonylurea, sitagliptin has been associated with an increased
risk of hypoglycaemia. Therefore, a reduction in the dose of the
sulphonylurea may be necessary.

Dr Martin Hadley-Brown, chairman of the Primary Care Diabetes
Society in the UK, said, "The guideline for type 2 diabetes newer
agents is important for healthcare professionals because it helps
clarify which patients are appropriate candidates for these newer
treatments. With a chronic condition such as diabetes it is essential
that patients are educated about their condition, have access to a
wide range of treatment options and maintain the best quality of life
possible. The guideline for type 2 diabetes newer agents certainly
supports these efforts."

In addition, the NICE guideline recognises the role of
sitagliptin as the only DPP-4 inhibitor licensed for use in triple
therapy with metformin and an SU where metformin and an SU do not
adequately control blood sugar (HbA1c greater than or equal to 7.5%
or other higher level agreed with the individual) and insulin is
considered inappropriate or unacceptable to the patient.(1)

As a once-daily tablet, sitagliptin provides a convenient
treatment option for patients and has over ten million prescriptions
worldwide since launch.(5) "We are delighted that, in its guideline
for type 2 diabetes newer agents, NICE has recognised the DPP-4
inhibitor class as a potential alternative to SU in selected
patients" Dr Paul Leigh, MSD Diabetes, commented. "At MSD, we strive
to develop new medicines that can make a difference to patients'
lives, so it is pleasing to know that patients and HCPs can now
benefit from a wider range of treatments."

Notes to Editors

About sitagliptin

Sitagliptin is a member of a class of oral anti-hyperglycaemic
agents called dipeptidyl peptidase 4 (DPP-4) inhibitors and is
licensed in the UK for the treatment of type 2 diabetes in
combination with either metformin and/or a sulphonylurea, or in
certain patients, with a PPARy agonist (i.e. thiazolidinedione), when
diet and exercise plus the other agent(s) do not provide adequate
glycaemic control.(6)

Sitagliptin enhances the body's own ability to lower blood sugar
levels by increasing the levels of the body's own active incretins,
called GLP-1 and GIP.

The recommended dose of sitagliptin is 100mg once daily, with
or without food, for all approved indications.(6)

Sitagliptin should not be used in patients with moderate or
severe renal impairment or in patients with hepatic insufficiency. It
is contraindicated in patients with: hypersensitivity to the active
substances or to any of the excipients; diabetic ketoacidosis,
diabetic pre-coma; acute conditions with the potential to alter renal
function; acute or chronic disease which may cause tissue hypoxia;
acute alcohol intoxication, alcoholism; or in woman who are lactating
or pregnant. No liver function tests need to be performed prior to
the initiation of treatment. See Summary of Product Characteristics
for further details.

About hypoglycaemia

Hypoglycaemia occurs when the level of glucose in the blood falls
too low, usually under 4 mmol/l. People with diabetes who take
insulin and/or certain diabetes tablets are at risk of having
hypoglycaemia. It may occur if someone has taken too much diabetes
medication, delayed or missed a meal or snack, not eaten enough
carbohydrate, taken part in unplanned or more strenuous exercise than
usual, and has been drinking alcohol without food. Sometimes there is
no obvious cause. When hypoglycaemia happens the person often
experiences 'warning signs', which occur as the body tries to raise
the blood glucose level. These 'warning signs' vary from person to
person but often include feeling shaky, sweating, tingling in the
lips, going pale, heart pounding, confusion and irritability.

Treatment is usually very simple and requires taking some fast
acting carbohydrate, such as a sugary drink or some glucose tablets,
and following this up with some longer acting carbohydrate, such as a
cereal bar. If left untreated the person might, eventually, become
unconscious and would need to be treated with an injection of
glucagon (a hormone that raises blood glucose levels). But in the
vast majority of cases the body will release its own stores of
glucose and raise the blood glucose level to normal, though this may
take several hours.(7)

About NICE

The National Institute for Health and Clinical Excellence
(NICE)is the independent organisation responsible for providing
national guidance on the promotion of good health and the prevention
and treatment of ill health in the UK.

NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and
the prevention of ill health for those working in the NHS, local
authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing
medicines, treatments and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and
care of people with specific diseases and conditions within the NHS

NICE guidance is developed using the expertise of the NHS and the
wider healthcare community including NHS staff, healthcare
professionals, patients and carers, industry and the academic world.

Other agents reviewed in the NICE guideline on newer agents for
blood glucose in type 2 diabetes include the Thiazolidinediones,
GLP-1 mimetic and long-acting human insulin analogues.

About Merck Sharp & Dohme Limited

Merck Sharp & Dohme Limited (MSD) is the UK subsidiary of Merck &
Co., Inc., of Whitehouse Station, New Jersey, USA, a leading
research-based pharmaceutical company that discovers, develops,
manufactures and markets a wide range of innovative pharmaceutical
products to improve human health.

'Januvia'(R) is a Registered Trademark of Merck & Co., Inc.,
Whitehouse Station, New Jersey, USA.

References:
(1) National Institute for health and Clinical Excellence. Type 2
diabetes: newer agents for blood glucose in type 2 diabetes. Review
of NICE technology appraisal guidance 66. May 2009. www.nice.org.uk
(2) Diabetes Atlas. http://www.eatlas.idf.org/
(3) Diabetes Impact Survey Report, MSD Diabetes.
(4) Krobot KJ, Stein PP, Alen S et al. Lower risk of hypoglycaemia with
sitagliptin compared to glipizide when added to ongoing metformin
therapy: An analysis based on A1C-adjusted event rates. Abstract
presented at the 68th Scientific Sessions of the American Diabetes
Association, June 2008, San Francisco.
(5) IMS Health, NPA(TM) Weekly, TRxs: data on file
(6) 'Januvia' (sitagliptin). Summary of Product Characteristics. MSD UK
2007
(7) Diabetes UK. Guide to diabetes.
http://www.diabetes.org.uk/Guide-to-diabetes/complications/short_term_complications/hypoglycaemia

For further information, please contact:
Diane Wass / Louise Barr
Merck Sharp & Dohme Limited
Office: +44(0)1992-457272 / 462126
diane_wass@merck.com
louise_barr@merck.com
Georgie Griffith / Katie Armson
Cohn & Wolfe
Office: +44(0)20-7331-5369 / 5330
georgie.griffith@cohnwolfe.com
katie.armson@cohnwolfe.com

ots Originaltext: Merck Sharp & Dohme Limited
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Contact:
For further information, please contact: Diane Wass / Louise Barr,
Merck Sharp & Dohme Limited, Office: +44(0)1992-457272 / 462126,
diane_wass@merck.com, louise_barr@merck.com; Georgie Griffith /
Katie Armson, Cohn & Wolfe, Office: +44(0)20-7331-5369 / 5330,
georgie.griffith@cohnwolfe.com, katie.armson@cohnwolfe.com