Merck Presents Scientific Data at the European Association for the Study of Diabetes Annual Meeting
Studies Include First Phase 3 Data for Omarigliptin, an Investigational Once-weekly DPP-4 inhibitor
Monday, September 8, 2014 8:00 am EDT
WHITEHOUSE STATION, N.J., September 08, 2014 – Attendees at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna will have the opportunity to learn about several scientific studies and analyses presented by Merck (NYSE: MRK), known as MSD outside the United States and Canada. The research includes the first phase 3 data for Merck’s investigational, once-weekly DPP-4 inhibitor, omarigliptin, as well as real-world research studies with Merck’s DPP-4 inhibitor, JANUVIA® (sitagliptin).
“Merck remains fully committed to the fight against the global epidemic of diabetes and to providing solutions for clinicians and patients as they manage this disease every day,” says Peter Stein, M.D., vice president, Clinical Research, Diabetes and Endocrinology, Merck Research Laboratories. “We are pleased to share some of our latest research findings at this important scientific congress.”
Abstracts to be presented include:
Novel compounds on the horizon
Effect of a novel once weekly DPP-4 inhibitor,
omarigliptin in patients with type 2 diabetes: a
placebo- and sitagliptin-controlled, non-inferiority trial
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Wednesday 17 September 15.30-17.00
OP 20
Presentation number: #115
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Pharmaco-epidemiology
Factors associated with adherence to oral
antihyperglycemic monotherapy in patients with
type 2 diabetes in the UK
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Tuesday 16 September, 13:00-14:00
PS 007
Presentation number: #322
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Clinical studies with DPP-4 inhibitors
Assessing time to insulin use among type 2
diabetes patients treated with sitagliptin or
sulfonylurea plus metformin dual therapy
Duration of maintenance of dual therapy with
metformin and sitagliptin in type 2 diabetes-the
ODYSSÉE observational study
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Wednesday 17 September 14:15-15:15
PS 070
Presentation number: #898
Wednesday 17 September 14:15-15:15
PS 070
Presentation number: #901
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Insulin secretagogues
Risk factors associated with treatment
discontinuation and down-titration in type 2
diabetes patients treated with sulfonylureas
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Tuesday 16 September, 13:00-14:00
PS 061
Presentation number: #808
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Impact of hypoglycemic events and HbA1c level
on sulfonyulrea discontinuation and down-titration
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Tuesday 16 September, 13:00-14:00
PS 061
Presentation number: #811
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Nephropathy: biomarkers and infections
Epidemiology of urinary tract infections in type 2
diabetes mellitus patients and associated
healthcare cost
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Tuesday, 16 September, 11:00-12:30
OP 02
Presentation number: #12
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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(continued)
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 incidence (and rate) 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, Facebookand 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 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).
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