Merck & Co., Inc. (MRK) to Present New Data, Including JANUVIA® (Sitagliptin) and Omarigliptin Data, at the 73rd Scientific Sessions of the American Diabetes Association
6/21/2013 1:53:12 PM
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June 21, 2013 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada,will present more than a dozen new studies related to type 2diabetes, including data for its once-daily DPP-4 inhibitor JANUVIA® (sitagliptin)used for the treatment of adults with type 2 diabetes and for its novel, investigational once-weekly DPP-4 inhibitor omarigliptin, at the 73rd Scientific Sessions of the American Diabetes Association (ADA) being held in Chicago, June 21-25, 2013.Other data being presented include studies that address current management of diabetes and selected complications of diabetes.
JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor 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.
“Merck is committed to diabetes research and to advancing the medical community’s understanding of how to better manage type 2 diabetes,” said Peter Stein, vice president of Clinical Research for diabetes and endocrinology, Merck Research Laboratories. “For many years, Merck has actively engaged in scientific discussions at this pivotal meeting. We are excited to share the breadth of our new data at the 73rd Scientific Sessions of the American Diabetes Association.”
Select Scientific Abstracts to be Presented
• Comparison of Treatment with Sitagliptin or Sulfonylurea in Patients with Type 2 Diabetes Mellitus and Mild Renal Insufficiency (549-P; Saturday, June 22, 2013 11:30 AM – 1:30 PM)
• Metabolic Effects and Safety of Single Rising-Dose Sitagliptin in Adolescents with Type 2 Diabetes (1303-P; Saturday, June 22, 11:30 AM – 1:30 PM)
• Pharmacokinetics and Pharmacodynamics of Sitagliptin in Adolescents with Type 2 Diabetes(1315-P; Saturday, June 22, 2013 11:30 AM - 1:30 PM)
• Safety and Efficacy of Sitagliptin Added to the Combination of Sulfonylurea and Metformin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control (1148-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of Multiple-Dose Administration of Omarigliptin, a Novel Once-Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitor, in Obese Subjects With and Without Type 2 Diabetes Mellitus (1106-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Effects of Age, Gender and Obesity on the Single Dose Pharmacokinetics (PK) of Omarigliptin, a Novel Once-Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitor (1157-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Single-/Multiple-Dose Pharmacokinetics (PK) and Pharmacodynamics (PD) of Omarigliptin, a Once-Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitor, in Healthy Subjects (1097-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Oxyntomodulin has Significant Acute Glucoregulatory Effects in Non-Diabetic Humans (1990-P; Saturday, June 22, 2013 11:30 AM – 1:30 PM)
• Oxyntomodulin has Significant Acute Glucoregulatory Effects Comparable to Liraglutide in Subjects with Type 2 Diabetes (186-OR; Sunday, June 23, 2013 8:00 – 10:00 AM)
• Sulfonylureas Associated with Higher Emergency Room usein Elderly with Diabetes (1070-P; Sunday, June 23, 2013 12:00– 2:00 PM; Audio tour on Sunday, June 23,2013 12:00 – 2:00 PM; Audio tour on Saturday, June 22, 2013 12:30 – 1:30 PM)
• Early Dual Therapy is Associated with Improved Glycemia in Type 2 Diabetes: A Meta-analysis (1063-P; Sunday, June 23, 2013 12:00 – 2:00 PM; Audio tour on Monday, June 24, 2013 12:00 – 1:00 PM)
• Factors Associated with Adherence to Oral Antihyperglycemic Monotherapy in Patients with Type 2 Diabetes (1285-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Patient Preferences for Oral Antihyperglycemic Therapy (210-OR; Sunday, June 23, 2013 2:15 – 4:15 PM)
• Prevalence of Psoriasis in Patients with Type 2 Diabetes (1572-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Comparison of Risk Adjustment Methods to Predict Non-Skin Cancer, Stroke and Myocardial Infarction (MI) in Patients with Type 2 Diabetes Mellitus (1407-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Characterization of the Risk for Urinary Tract Infections in Patients with Type 2 Diabetes (1509-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Disease Burden of Urinary Tract Infections Among Type 2 Diabetes Mellitus Patients: A U.S. Database Study (1511-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
• Relatively Small Increases in LDL-Cholesterol are Associated with Elevation in Coronary Heart Disease Risk in Diabetes (1425-P; Sunday, June 23, 2013 12:00 – 2:00 PM)
Selected Important Risk Information About JANUVIA® (sitagliptin) 50 mg, 100 mg tablets
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® (sitagliptin) 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 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®(sitagliptin).
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.
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.
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 2012 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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