WHITEHOUSE STATION, N.J. - Saturday, June 7th 2014 [ME NewsWire]
(BUSINESS WIRE)-- MSD, known as Merck (NYSE:MRK) in the United States and Canada, will present 13 new studies and analyses, including data for its DPP-4 inhibitor JANUVIA® (sitagliptin) and for its investigational once-weekly DPP-4 inhibitor omarigliptin, at the 74th Scientific Sessions of the American Diabetes Association (ADA) being held in San Francisco, June 13-17, 2014.
Several analyses of patient outcomes in real-world settings will also be presented.
“Merck is dedicated to helping patients with diabetes and transforming the way diabetes is managed throughout the world, as a part of our commitment to being a global leader in diabetes care,” said Peter Stein, M.D., vice president of Clinical Research for diabetes and endocrinology, Merck Research Laboratories. “We are pleased to share new data on our diabetes portfolio and pipeline.”
Abstracts to be presented include:
Late-breaking
Treatment Maintenance Duration Of Dual Therapy With Metformin And Sitagliptin In Type 2 Diabetes - The ODYSSÉE Observational Study
Sunday, June 15, 12:00-2:00 p.m. PDT 136-LB
Discontinuation of Oral Antihyperglycemic Agents among Diabetes Patients
Sunday, June 15, 12:00-2:00 p.m. PDT
160-LB
Assessing Time to Insulin Use Among Type 2 Diabetes Patients Treated with Sitagliptin or Sulfonylurea Plus Metformin Dual Therapy
Sunday, June 15, 12:00-2:00 p.m. PDT
169-LB
Clinical Research
Clinical Therapeutics/New Technology–Oral Agents
Patterns of Reported Nocturnal Hypoglycemia in Patients with Type 2 Diabetes Intensively Treated with Insulin Glargine with or without Sitagliptin
Guided Audio Poster Tour
Saturday, June 14 12:30-1:20 p.m. PDT General Poster Session Sunday,
June 15 12:00-2:00 p.m. PDT 1027-P
Addition of Sitagliptin Improved Glycemic Control and Was Well Tolerated in Japanese Patients with Type 2 Diabetes on Glinides Monotherapy
Sunday, June 15 12:00-2:00 p.m. PDT 1039-P
Absorption, Metabolism and Excretion of Omarigliptin, a Once Weekly DPP-4 Inhibitor, in Humans
Sunday, June 15 12:00-2:00 p.m. PDT 1080-P
Observational Studies
Epidemiology
Sulfonylurea Use and Risk of Coronary Heart Disease Among Patients with Type 2 Diabetes: Prospective Cohort Study Among Women
Guided Audio Poster Tour
Saturday, June 14 11:30 a.m.-12:20 p.m. PDT General Poster Session
Sunday, June 15 12:00-2:00 p.m. PDT 1426-P
Factors Associated with Discontinuation of Sulfonylurea Therapy in Type 2 Diabetes Patients Who Initiate Insulin
Sunday, June 15 12:00-2:00 p.m. PDT 1521-P
Risk Factors Associated with Treatment Discontinuation and Down-Titration in Type 2 Diabetes Patients Treated with Sulfonylureas
Sunday, June 15 12:00-2:00 p.m. PDT 1522-P
Prevalence of Missed Doses of Oral Agents for Diabetes Among US patients with Type 2 Diabetes
Sunday, June 15 12:00-2:00 p.m. PDT 1528-P
Characterization of Sitagliptin Use in Patients with Type 2 Diabetes and Chronic Renal Disease
Sunday, June 15 12:00-2:00 p.m. PDT 1431-P
Therapeutics/New Technology–Oral Agents
Urinary Albumin Secretion in Type 2 Diabetes Patients (T2DM) with Albuminuria Treated with Sitagliptin as Add-on Therapy to Metformin: A Real-World Data Study
Sunday, June 15 12:00-2:00 p.m. PDT 1061-P
Healthcare Delivery/Economics
Adherence to Treatment Guidelines in Type 2 Diabetes Patients Treated with Metformin Monotherapy with Suboptimal Glycemic Control in Israeli Managed Care
Sunday, June 15 12:00-2:00 p.m. PDT 1168-P
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, please 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 Merck’s 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 MSD, a subsidiary of Merck & Co., Inc.
Contacts
MSD
Media:
Michael Close, +1-267-305-1211
Pam Eisele, +1-908-423-5042
Investors:
Carol Ferguson, +1-908-423-4465
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