2008 Canadian Diabetes Association clinical practice guidelines now include new class of DPP-4 inhibitors


    JANUVIA(TM) (sitagliptin) is the first and only agent of this class
    available in Canada

    MONTREAL, Sept. 19 /CNW Telbec/ - The new 2008 clinical practice
guidelines for type 2 diabetes from the Canadian Diabetes Association now
includes the new class of dipeptidyl peptidase-4 (DPP-4) inhibitors. As
Canada's first and only available DPP-4 inhibitor, JANUVIA(TM) (sitagliptin)
is included as a first line add-on to metformin in the algorithm of treatment
to be prescribed for adult patients with type 2 diabetes when diet and
exercise plus metformin alone do not provide adequate blood glucose control.
Metformin is the recommended first-line treatment by the clinical practice
    The new guidelines specify that the advantages for the DPP-4 inhibitors
class include being weight neutral with a low risk of hypoglycemia and an
improved glucose level after meals (post-prandial). Some of the available
medications to lower blood glucose might cause some weight gain and
hypoglycemia by lowering the blood glucose to a very low level. In fact, in a
Canadian survey conducted in 2007 with 500 people living with type 2 diabetes
and 200 physicians, weight gain and hypoglycemia were the two most common side
effects reported by physicians and patients when taking other
antihyperglycemic agents. Post prandial hyperglycemia is a powerful predictor
of adverse outcomes such as cardiovascular diseases and microvascular
    "The hope of these guidelines is that it will be an important resource
for aiding health care professionals in managing individuals with diabetes,"
said Dr. Vincent Woo, Assistant Professor of Medicine, section of
endocrinology and metabolism at the University of Manitoba. "Type 2 diabetes
is a progressive condition with glucose control worsening over time. Therefore
treatments must remain dynamic and additional agents are needed as time goes
by. New classes of agents that give improvements in glucose control with fewer
side-effects are welcomed as part of the "tool kit" to help individuals with
type 2 diabetes."

    Enhances natural body system

    Sitagliptin is a highly selective, once-daily DPP-4 inhibitor that
enhances a natural body system, called the incretin system, to help regulate
blood sugar. Incretins are hormones produced in the gut in response to a meal.
When blood sugar is elevated, incretins work in two ways to help the body
regulate high blood sugar levels. They trigger the pancreas to increase the
release of insulin and signal the liver to reduce its production of glucose.
Sitagliptin keeps these hormones active for a longer period of time by
preventing their breakdown.

    New data demonstrates efficacy and tolerability of sitagliptin up to two

    New data analyses presented in September 2008 at the 44th Annual Meeting
of the European Association for the Study of Diabetes (EASD) showed initial
combination therapy with the DPP-4 inhibitor, sitagliptin, and metformin
provided powerful improvements in blood sugar levels (as measured by HbA1c(*))
over two years of treatment and was generally well tolerated. Also presented
at the meeting was a separate, new pooled analysis of 6,139 patients that
shows that sitagliptin 100 mg a day was generally well tolerated in clinical
trials up to two years in duration.(3)

    Type 2 diabetes, a growing concern

    Currently there are more than two million Canadians living with type 1
and type 2 diabetes.(4) It is estimated that over three million Canadians will
be diagnosed with diabetes by 2010.(4) Type 2 diabetes accounts for 90 per
cent of all diagnosed cases of diabetes(5) but it has been estimated that
about one third of adults with type 2 diabetes are unaware of their
condition.(6) One in two Canadians being treated for type 2 diabetes does not
achieve the targeted HbA1c level of (less than or equal to)7 per cent as per
the 2008 Canadian Diabetes Association Guidelines. The percentage of patients
with type 2 diabetes who do not achieve adequate blood sugar control increases
the longer the patients have the disease.(7)
    "These new treatment recommendations from the CDA come at an important
time," said Mr. Serge Langlois, President and Executive Director of Diabetes
Québec. "A Canadian survey conducted last year among 200 physicians treating
people with type 2 diabetes showed that one-third of physicians and two-thirds
of endocrinologists felt there were not enough treatment options available to
them. More than ever, there is a need for more effective and tolerable options
to help people living with type 2 diabetes better control their blood glucose
level in order to avoid complications such as blindness and amputation which
unfortunately can eventually happen."

    Commitment to diabetes

    Recognizing the toll that diabetes is taking globally, Merck Frosst is
committed to the research and development of diabetes medications to bring new
treatment options to physicians and patients who struggle with managing the
complexity of type 2 diabetes.
    JANUVIA(TM) was awarded the Prix Galien USA 2007 Award for the Best
Pharmaceutical Agent. The Prix Galien recognizes outstanding achievement in
the pharmaceutical industry in the development of new medicines.

    About Merck Frosst

    At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a
research-driven pharmaceutical company discovering, developing and marketing a
broad range of innovative medicines and vaccines to improve human health.
Merck Frosst is one of the top 25 R&D investors in Canada, with an investment
of close to $110 million in 2007. More information about Merck Frosst is
available at http://www.merckfrosst.com.

    Forward-Looking Statement

    This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential or financial performance. No
forward-looking statement can be guaranteed, and actual results may differ
materially from those projected. Merck undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that affect Merck's
business, particularly those mentioned in the cautionary statements in Item 1A
of Merck's Form 10-K for the year ended Dec. 31, 2007, and in its periodic
reports on Form 10-Q and Form 8-K, which the Company incorporates by

    (*)  HbA1c is a measure of a person's average blood glucose over a two-
         month to three-month period.

    (TM) Trademark of Merck Frosst Canada Ltd., used under license


    (1)  Canadian Diabetes Association 2008 Clinical Practice Guidelines for
         the prevention and management of Diabetes in Canada. Canadian
         Journal of Diabetes volume 32 suppl 1 page S29.
    (2)  Qi DS., et al. Two year treatment with sitagliptin and initial
         combination therapy of sitagliptin and metformin provides
         substantial and durable glycemic control in patients with type 2
         diabetes. EASD Abstract August, 2008.
    (3)  Williams-Herman, D. et al. Safety and tolerability of sitagliptin, a
         selective DPP-4 inhibitor, in patients with type 2 diabetes: pooled
         analysis of 6139 patients in clinical trials for up to 2 years. EASD
         Abstract August, 2008.
    (4)  Diabetes Progress Report 2005, Canadian Diabetes Association.
         Website accessed at
    (5)  Health Canada website, It's Your Health - Type 2 Diabetes. Website
         accessed at
    (6)  Young, TK and Mustard, CA. Undiagnosed diabetes: Does it matter?
         CMAJ. 2001,164: 24-28.
    (7)  Harris SB, Ekoé J-M, et al. Glycemic Control and Morbidity in the
         Canadian Primary Care Setting (Results of the Diabetes In Canada
         Evaluation Study). Diabetes Research and Clinical Practice. October

For further information:

For further information: Martine Drolet, Manager, Public Affairs, Merck
Frosst Canada Ltd., (514) 428-3037; Barbara Biggar, Biggar Ideas/Winnipeg,
Home: (204) 883-2699, Cell: (204) 781-0747, biggar@mts.net; Marie-Michelle
Crevier, Cohn & Wolfe/Montréal, (514) 845-2257 ext. 236,
marie-michelle.crevier@cohnwolfe.ca; Mélissa Maloul-Cohen, Cohn &
Wolfe/Montréal, (514) 845-2257 ext. 228, melissa.maloul-cohen@cohnwolfe.ca;
Aliya Ladha, Cohn & Wolfe/Toronto, (647) 259-3273, Aliya.Ladha@cohnwolfe.ca

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