Omarigliptin significantly reduced HbA1c levels compared to placebo
Company Website:
http://www.merck.com
VIENNA -- (Business Wire)
MSD, known as Merck & Co., Inc. (NYSE:MRK) in the United States and
Canada, today announced the presentation of the first data from the
Phase 3 clinical development program for omarigliptin, MSD’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 MSD’s once-daily DPP-4
inhibitor, JANUVIA® (sitagliptin) 50 mg, which is the
standard starting dose for sitagliptin in Japan.1 MSD
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. “MSD 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.”
MSD 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, MSD 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 HbA1c*
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 24.1
About JANUVIA® (sitagliptin)
JANUVIA®is indicated as an adjunct to diet and
exercise to improve glycemic control in patients with type 2 diabetes
mellitus as initial therapy, alone or in combination with metformin, or
a PPARγ agonist, or as an add-on to metformin, PPARγ agonist,
sulfonylurea, sulfonylurea + metformin or PPARγ agonist + metformin when
the current regimen, with diet and exercise does not provide adequate
glycemic control. JANUVIA can also be used as an adjunct to diet and
exercise to improve glycemic control in combination with insulin (with
or without metformin).
Important Selected Safety Information About Sitagliptin
JANUVIA is contraindicated in patients who are hypersensitive to any
components of this product.JANUVIA should not be used in
patients with type 1 diabetes or for the treatment of diabetic
ketoacidosis.
There have been postmarketing reports of acute pancreatitis, including
fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients
taking JANUVIA. Because these reports are made voluntarily from a
population of uncertain size, it is generally not possible to reliably
estimate their frequency or establish a causal relationship to drug
exposure. Patients should be informed of the characteristic symptom of
acute pancreatitis: persistent, severe abdominal pain. Resolution of
pancreatitis has been observed after discontinuation of JANUVIA. If
pancreatitis is suspected, JANUVIA and other potentially suspect
medicinal products should be discontinued. A dosage adjustment is
recommended in patients with moderate or severe renal insufficiency or
with end-stage renal disease requiring hemodialysis or peritoneal
dialysis.
As with other antihyperglycemic agents, when JANUVIA was used in
combination with a sulfonylurea or with insulin, medications known to
cause hypoglycemia, the incidence of sulfonylurea- or insulin-induced
hypoglycemia was increased over that of placebo. To reduce the risk of
sulfonylurea- or insulin-induced hypoglycemia, a lower dose of
sulfonylurea or insulin may be considered.
There have been postmarketing reports of serious hypersensitivity
reactions in patients treated with JANUVIA including anaphylaxis,
angioedema, and exfoliative skin conditions including Stevens-Johnson
syndrome. Because these reactions are reported voluntarily from a
population of uncertain size, it is generally not possible to reliably
estimate their frequency or establish a causal relationship to drug
exposure. 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.
In clinical studies as monotherapy and in combination with other agents,
the adverse experiences reported regardless of causality assessment in
≥5% of patients and more commonly than placebo or the active comparator
included hypoglycemia, nasopharyngitis, upper respiratory tract
infection, headache, and peripheral edema.
For additional adverse experience information, see the product
circular.
In clinical studies, the safety and effectiveness of JANUVIA in the
elderly (≥65 years) were comparable to those seen in patients <65 years.
No dosage adjustment is required based on age. In elderly patients with
significant renal insufficiency dosage adjustment may be required.
Before initiating therapy, please consult the full prescribing
information.
About MSD
Today's MSD is a global healthcare leader working to help the world be
well. MSD is a tradename of Merck & Co., Inc., with headquarters in
Whitehouse Station, N.J., U.S.A. 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.msd.com.
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 MSD’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; MSD’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 MSD patents and other protections for
innovative products; and the exposure to litigation, including patent
litigation, and/or regulatory actions.
MSD 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 MSD’s/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).
JANUVIA® is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
* HbA1c is an estimate of a person's average blood glucose
over a two- to three-month period.
1 Gantz, I et al. Effect of a novel once weekly DPP-4
inhibitor, omarigliptin in patients with type 2 diabetes: a
double-blind, placebo- and sitagliptin-controlled, non-inferiority
trial. Presentation 115, presented at 50th EASD Annual Meeting on
September 17 2014. Available at http://www.easd.org/images/easdwebfiles/annualmeeting/50thmeeting/Prog-at-Glance.html.
Last accessed September 2014
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Source: MSD
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