Additional Analyses from the TECOS
Cardiovascular Safety Trial of JANUVIA®
(sitagliptin) Also to Be Presented
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that researchers will present data from
clinical trials of its investigational diabetes pipeline, JANUVIA®
(sitagliptin), and new real-world research in more than 20
scientific data presentations at the 76th Scientific Sessions of
the American Diabetes Association (ADA) being held in New Orleans,
June 10-14, 2016. New investigational clinical trial data to be
presented include the first Phase 3 results for ertugliflozin, an
oral SGLT2 inhibitor in development with Pfizer for patients with
type 2 diabetes, and for MK-1293, Merck’s follow-on biologic
insulin glargine candidate being evaluated for patients with type 1
and type 2 diabetes. Additional analyses will also be presented
from the TECOS (Trial Evaluating Cardiovascular Outcomes with
Sitagliptin) cardiovascular safety trial of JANUVIA.
“At Merck, we have a long-term commitment to diabetes research
and advancing the care of people living with diabetes around the
world,” said Peter Stein, M.D., vice president, late stage
development, diabetes and endocrinology, Merck. “We look forward to
presenting new clinical trial data and results of several studies
from real-world settings at this year’s American Diabetes
Association Scientific Sessions.”
Indications and Usage for JANUVIA (sitagliptin) 25 mg,
50 mg and 100 mg tablets
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.
Selected Important Risk Information about JANUVIA
JANUVIA is contraindicated in patients with a history of a
serious hypersensitivity reaction to sitagliptin, such as
anaphylaxis or angioedema.
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.
Selected Important Risk Information about JANUVIA continued
below.
Abstracts
Select abstracts to be presented include the following:
Ertugliflozin
- Ertugliflozin: Glycemic control as
monotherapy in patients with T2DM (Abstract #130-LB, Sunday, June
12, 12:00-2:00 p.m. CT)
- Effect of ertugliflozin plus
sitagliptin on glycemic control vs. either treatment alone in
subjects with T2DM inadequately controlled with metformin (Abstract
#125-LB, Sunday, June 12, 12:00-2:00 p.m. CT)
Ertugliflozin (MK-8835) is being developed in collaboration with
Pfizer, Inc. for the treatment of patients with type 2
diabetes.
MK-1293
- Efficacy and safety of MK-1293 insulin
glargine compared with originator insulin glargine (Lantus) in type
2 diabetes (T2D) (Abstract #926-P, Saturday, June 11, 11:30
a.m.-1:30 p.m. CT)
- A single-dose euglycemic clamp study in
subjects with type 1 diabetes demonstrating pharmacokinetic and
pharmacodynamic similarity between MK-1293 insulin glargine and
originator insulin glargine (Lantus) (Abstract #946-P, Saturday,
June 11, 11:30 a.m.-1:30 p.m. CT)
- Efficacy and safety of MK-1293 insulin
glargine compared with originator insulin glargine (Lantus) in type
1 diabetes (T1D) (Abstract #296-OR, Monday, June 13, 9:30-9:45 a.m.
CT)
MK-1293 is being developed by Merck for the treatment of
patients with type 1 and type 2 diabetes, and Samsung Bioepis
is partially funding its development.
JANUVIA® (sitagliptin)
- Assessing the safety of sitagliptin in
patients with type 2 diabetes and chronic kidney disease in the
Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS)
(Abstract #1181-P, Sunday, June 12, 12:00-2:00 p.m. CT)
- A pooled analysis: Reduction of
hypoglycemic event rate with sitagliptin compared with sulfonylurea
(Abstract #1112-P, Sunday, June 12, 12:00-2:00 p.m. CT)
- Sitagliptin and risk of fractures in
type 2 diabetes: Results from the TECOS trial (Abstract #587-P,
Monday, June 13, 12:00-2:00 p.m. CT)
Real-World Data – Type 2 Diabetes
- Clinical inertia in patients with type
2 diabetes mellitus at a large, integrated, U.S. health care system
(Abstract #1442-P, Sunday, June 12, 12:00-2:00 p.m. CT)
- Frequency of documented hypoglycemia
among U.S. patients with type 2 diabetes and insulin treatment
(Abstract #396-P, Sunday, June 12, 12:00-2:00 p.m. CT)
- Direct medical costs of severe
hypoglycemic events among type 2 diabetes patients in UK (Abstract
#1464-P, Sunday, June 12, 12:00-2:00 p.m. CT)
- History of hypoglycemic events more
than knowledge predicts fear of hypoglycemia in T2DM (Abstract
#400-P, Sunday, June 12, 12:00-2:00 p.m. CT)
- A retrospective cohort study on
conversion to diabetes among a prediabetic adult population in
China (Abstract #1423-P, Sunday, June 12, 12:00-2:00 p.m. CT)
- Survival in people with type 2 diabetes
with lower glycosylated hemoglobin (Abstract #173-OR, Saturday,
June 11, 5:30-5:45 p.m. CT)
- External validation of the UK
Prospective Diabetes Study risk equations in 14,740 Israel type 2
diabetes patients (Abstract #354-OR, Monday, June 13, 5:30-5:45
p.m. CT)
- Intensification of therapy and time
until A1c goal attainment among patients with new-onset type 2
diabetes (T2D) who fail metformin monotherapy within a large
integrated health system (Abstract #363-OR, Monday, June 13,
5:45-6:00 p.m. CT)
- Prevalence of diabetes in U.S. Medicaid
pediatric population, 2002-2013 (Abstract #156-LB, Sunday, June 12,
12:00-2:00 p.m. CT)
For more information, including a complete list of abstract
titles at the meeting, please visit:
http://professional.diabetes.org/meeting/scientific-sessions/76th-scientific-sessions.
Selected Important Risk Information about JANUVIA
(continued)
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 incidence (and rate) of hypoglycemia based on all reports of
symptomatic hypoglycemia were: 12.2% (0.59 episodes/patient-year)
for JANUVIA 100 mg in combination with glimepiride (with or without
metformin), 1.8% (0.24 episodes/patient-year) for placebo in
combination with glimepiride (with or without metformin), 15.5%
(1.06 episodes/patient-year) for JANUVIA 100 mg in combination with
insulin (with or without metformin), and 7.8% (0.51
episodes/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 postmarketing reports of severe and disabling
arthralgia in patients taking DPP-4 inhibitors. The time to onset
of symptoms following initiation of drug therapy varied from 1 day
to years. Patients experienced relief of symptoms upon
discontinuation of the medication. A subset of patients experienced
a recurrence of symptoms when restarting the same drug or a
different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible
cause for severe joint pain and discontinue drug if
appropriate.
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 ≥5% 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
For 125 years, Merck has been a global health care 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 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 health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’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; the company’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 the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company 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 the company’s 2015
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.
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