Merck to Present New Clinical Data on JANUVIA® (Sitagliptin), Investigational Omarigliptin, and Real-World Data in Patients with Type 2 Diabetes at the 74th Scientific Sessions of the American Diabetes Association

By Business Wire,  June 06, 2014, 08:00:00 AM EDT


WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside 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 data 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, 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, 12-2 p.m.

136-LB

 

Discontinuation of Oral Antihyperglycemic

Agents among Diabetes Patients

Sunday, June 15, 12-2 p.m.

160-LB

 

Assessing Time to Insulin Use among Type 2

Diabetes Patients Treated with Sitagliptin or

Sulfonylurea plus Metformin Dual Therapy

Sunday, June 15, 12-2 p.m.

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.

General Poster Session, Sunday,

June 15, 12-2 p.m.

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, 12-2 p.m.

1039-P

 

Absorption, Metabolism and Excretion of

Omarigliptin, a Once-Weekly DPP-4 Inhibitor,

in Humans

Sunday, June 15, 12-2 p.m.

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.

General Poster Session, Sunday,

June 15, 12-2 p.m.

1426-P

 

Factors Associated with Discontinuation of

Sulfonylurea Therapy in Type 2 Diabetes

Patients Who Initiate Insulin

Sunday, June 15, 12-2 p.m.

1521-P

 

Risk Factors Associated with Treatment

Discontinuation and Down-Titration in Type 2

Diabetes Patients Treated with Sulfonylureas

Sunday, June 15, 12-2 p.m.

1522-P

 

Prevalence of Missed Doses of Oral Agents

for Diabetes among U.S. Patients with Type 2

Diabetes

Sunday, June 15, 12-2 p.m.

1528-P

 

Characterization of Sitagliptin Use in Patients

with Type 2 Diabetes and Chronic Renal

Disease

Sunday, June 15, 12-2 p.m.

1431-P

 

Therapeutics/New Technology - Oral

Agents

 

Urinary Albumin Secretion in Type 2 Diabetes

Patients with Albuminuria Treated with

Sitagliptin as Add-on Therapy to Metformin: a

Real-World Data Study

 

Sunday, June 15, 12-2 p.m.

1061-P

 

Health Care 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, 12-2 p.m.

1168-P

 

About 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.

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 (sitagliptin) 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.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or with any other anti-diabetic 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, Facebook and YouTube.

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).

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.

JANUVIA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Source: Merck



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Referenced Stocks: MRK


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