Omarigliptin significantly reduced HbA1c
levels compared to placebo
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the presentation of the first data from the
Phase 3 clinical development program for omarigliptin, Merck’s
investigational once-weekly DPP-4 inhibitor for the treatment of
type 2 diabetes. In a study in Japanese patients, omarigliptin
provided comparable efficacy and tolerability to Merck’s once-daily
DPP-4 inhibitor JANUVIA® (sitagliptin) 50 mg, which is the standard
starting dose for sitagliptin in Japan. Merck presented these data
on omarigliptin, which has been shown to produce sustained DPP-4
inhibition, at an oral session at the 50th European Association for
the Study of Diabetes (EASD) Annual Meeting.
“Despite advances in diabetes care in recent years, many people
living with type 2 diabetes are not at recommended blood sugar
goals,” said Peter Stein, M.D., vice president, Clinical Research,
Diabetes and Endocrinology, Merck Research Laboratories. “Merck is
committed to helping patients reduce the complexities of managing
diabetes. If approved, omarigliptin, as a once-weekly medication,
could provide an important new treatment option to help patients
attain their blood sugar goals.”
Merck is supporting omarigliptin with a global clinical
development program that includes 10 Phase 3 clinical trials
involving approximately 8,000 patients with type 2 diabetes. These
are the first Phase 3 data presented for omarigliptin and are the
pivotal data for filing in Japan. As previously announced, Merck
plans to file for approval in Japan by the end of 2014.
About the study
The Phase 3 double-blind, non-inferiority trial assessed the
efficacy, safety and tolerability of omarigliptin 25 mg once-weekly
compared to sitagliptin 50 mg once-daily (standard starting dose in
Japan), and to placebo. The primary efficacy endpoint was the
change in HbA1c1 levels from baseline at week 24.
At baseline, randomized patients (n=414) had a mean HbA1c
concentration of 7.9, 8.0 and 8.1 percent in the omarigliptin,
sitagliptin and placebo groups, respectively. Mean fasting plasma
glucose (FPG) levels were also similar between treatment
groups.
The primary objectives of the study were met, demonstrating at
24 weeks a significant change from baseline in lowering HbA1c
levels versus placebo, while demonstrating similar efficacy to
sitagliptin.
At week 24, omarigliptin significantly reduced HbA1c levels by
-0.80 percent from baseline relative to placebo. The change
relative to sitagliptin was -0.02 percent and met the prespecified
non-inferiority criterion. The pre-specified criterion was based on
the upper bound of the 95 percent confidence interval (CI) being
less than 0.3 percent. Fasting and two-hour post-meal blood sugar
levels also were significantly reduced from baseline with
omarigliptin and sitagliptin compared to placebo.
There were no meaningful differences in the incidences of
adverse events with omarigliptin compared to placebo and
sitagliptin. The most common adverse event that occurred with an
incidence of greater than 3 percent in the omarigliptin group was
nasopharyngitis, which occurred in 12.7 percent of those treated,
compared to 30.5 percent of patients receiving placebo and 11.0
percent of those receiving sitagliptin. Symptomatic hypoglycemia
was uncommon across all treatment groups in this study
[omarigliptin (0), sitagliptin (1), and placebo (0)]. Omarigliptin
was generally weight neutral, with a 0.04 kg mean change from
baseline at week 24.
About JANUVIA® (sitagliptin)
JANUVIA is indicated, as an adjunct to diet and exercise, to
improve glycemic control in adults with type 2 diabetes mellitus.
JANUVIA should not be used in patients with type 1 diabetes or for
the treatment of diabetic ketoacidosis. JANUVIA has not been
studied in patients with a history of pancreatitis. It is unknown
whether patients with a history of pancreatitis are at increased
risk of developing pancreatitis while taking JANUVIA. JANUVIA is
contraindicated in patients with a history of a serious
hypersensitivity reaction to sitagliptin, such as anaphylaxis or
angioedema.
Selected important risk information about JANUVIA
(sitagliptin) 25 mg, 50 mg and 100 mg tablets
There have been postmarketing reports of acute pancreatitis,
including fatal and nonfatal hemorrhagic or necrotizing
pancreatitis, in patients taking JANUVIA. After initiating JANUVIA,
observe patients carefully for signs and symptoms of pancreatitis.
If pancreatitis is suspected, promptly discontinue JANUVIA and
initiate appropriate management. It is unknown whether patients
with a history of pancreatitis are at increased risk of developing
pancreatitis while taking JANUVIA.
Assessment of renal function is recommended prior to initiating
JANUVIA and periodically thereafter. A dosage adjustment is
recommended in patients with moderate or severe renal insufficiency
and in patients with end-stage renal disease requiring hemodialysis
or peritoneal dialysis. Caution should be used to ensure that the
correct dose of JANUVIA is prescribed.
There have been postmarketing reports of worsening renal
function, including acute renal failure, sometimes requiring
dialysis. A subset of these reports involved patients with renal
insufficiency, some of whom were prescribed inappropriate doses of
sitagliptin.
When JANUVIA was used in combination with a sulfonylurea or
insulin, medications known to cause hypoglycemia, the incidence of
hypoglycemia was increased over that of placebo. Therefore, a lower
dose of sulfonylurea or insulin may be required to reduce the risk
of hypoglycemia.
The incidences (and rates) of hypoglycemia based on all reports
of symptomatic hypoglycemia were: 12.2 percent (0.59 episodes per
patient-year) for JANUVIA 100 mg in combination with glimepiride
(with or without metformin), 1.8 percent (0.24 episodes per
patient-year) for placebo in combination with glimepiride (with or
without metformin), 15.5 percent (1.06 episodes per patient-year)
for JANUVIA (sitagliptin) 100 mg in combination with insulin (with
or without metformin), and 7.8 percent (0.51 episodes per
patient-year) for placebo in combination with insulin (with or
without metformin).
There have been postmarketing reports of serious
hypersensitivity reactions in patients treated with JANUVIA, such
as anaphylaxis, angioedema and exfoliative skin conditions
including Stevens-Johnson syndrome. Onset of these reactions
occurred within the first 3 months after initiation of treatment
with JANUVIA, with some reports occurring after the first dose. If
a hypersensitivity reaction is suspected, discontinue JANUVIA,
assess for other potential causes for the event, and institute
alternative treatment for diabetes.
Angioedema has also been reported with other dipeptidyl
peptidase-4 (DPP-4) inhibitors. Use caution in a patient with a
history of angioedema with another DPP-4 inhibitor because it is
unknown whether such patients will be predisposed to angioedema
with JANUVIA.
There have been no clinical studies establishing conclusive
evidence of macrovascular risk reduction with JANUVIA or with any
other antidiabetic drug.
In clinical studies, the adverse reactions reported, regardless
of investigator assessment of causality, in greater than or equal
to 5 percent of patients treated with JANUVIA as monotherapy and in
combination therapy, and more commonly than in patients treated
with placebo, were upper respiratory tract infection,
nasopharyngitis and headache.
About Merck
Today’s Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside the United States and
Canada. Through our prescription medicines, vaccines, biologic
therapies, and consumer care and animal health products, we work
with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to healthcare through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook and
YouTube.
Merck’s Commitment to Diabetes
Through our research initiatives, on our own and in
collaboration with others, Merck is strengthening its leadership in
diabetes to deliver a broad portfolio of solutions to help improve
the management of diabetes.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; Merck’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Merck’s 2013 Annual
Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for JANUVIA (sitagliptin)
at
http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf
and Medication Guide for JANUVIA at
http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_mg.pdf.
JANUVIA® is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Inc.
1 HbA1c is an estimate of a person's average blood glucose over
a two- to three-month period.
MerckMedia:Pam Eisele, +1 (267) 305-3558Michael Close, +1 (267)
305-1221 or +1 (310) 617-1067orInvestors:Justin Holko, +1 (908)
423-5088
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