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Merck to Present New Phase 3 Data on Investigational Ertugliflozin, Additional Analyses of Studies of JANUVIA® (sitagliptin), and Real-World Evidence Research at the 77th Scientific Sessions of the American Diabetes Association

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that 19 scientific presentations from Merck’s diabetes pipeline and portfolio – including Phase 3 data for investigational ertugliflozin, additional analyses of JANUVIA® (sitagliptin), and real-world research – will be presented at the 77th Scientific Sessions of the American Diabetes Association (ADA) in San Diego, June 9-13, 2017. Oral and poster presentations of ertugliflozin, a SGLT-2 inhibitor in development with Pfizer, include new data from two Phase 3 studies and 52-week extension data from three other studies in the VERTIS clinical development program.

“Merck’s commitment to advancing the care of patients with diabetes continues in full force. At this year’s ADA, we look forward to sharing new clinical data with the scientific community that provide further insights into our established and investigational medicines for type 2 diabetes, and results of real-world studies on important type 2 diabetes-related topics such as hypoglycemia and clinical inertia,” said Sam Engel, M.D., associate vice president of cardiometabolic and women’s health, Merck Research Laboratories.

Abstracts

Select abstracts to be presented include the following:

Ertugliflozin

  • Safety and efficacy of ertugliflozin plus sitagliptin vs. either treatment alone after 52 weeks in subjects with T2DM inadequately controlled on metformin: VERTIS FACTORIAL trial extension (Abstract #130-OR; Saturday, June 10, 4:15-4:30 p.m. PDT)
  • Safety and efficacy of ertugliflozin after 52 weeks in subjects with T2DM inadequately controlled on metformin and sitagliptin: Results from the extension phase of the VERTIS SITA2 trial (Abstract #133-OR; Saturday, June 10, 5:00-5:15 p.m. PDT)
  • Effect of ertugliflozin on glycemic control, body weight, blood pressure (BP) and bone density (BMD) in T2DM inadequately controlled with metformin monotherapy: VERTIS MET trial (Abstract #1168-P; General Poster Session: Sunday, June 11, 12:00-1:00 p.m. PDT; Moderated Poster Session: Monday, June 12, 12:00-1:00 p.m. PDT)
  • Safety and efficacy of ertugliflozin in combination with sitagliptin in subjects with T2DM inadequately controlled on diet and exercise: The VERTIS SITA trial (Abstract #1197-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Long-term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: The 52-week VERTIS MONO study (Abstract #1208-P; Sunday, June 11, 12:00-1:00 p.m. PDT)

JANUVIA ® (sitagliptin)

  • Efficacy and safety of sitagliptin in subjects with T2DM and depression using antidepressant medications (Abstract #1309-P; Saturday, June 10, 11:30 a.m.-12:30 p.m. PDT)
  • Time to insulin in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) (Abstract #1183-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Efficacy and safety of sitagliptin in Hispanic subjects with T2DM (Abstract #1207-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Emerging sitagliptin benefit for all-cause hospitalizations: Evidence from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) (Abstract #1344-P; Sunday, June 11, 12:00-1:00 p.m. PDT)

Real-World Data – Type 2 Diabetes

  • The relationship between hypoglycemia severity and health-related quality of life among U.S. patients with type 2 diabetes (Abstract #397-P; Saturday, June 10, 11:30 a.m.-12:30 p.m. PDT)
  • Trends in glycemic medications and control in youths with type 2 diabetes (T2D): The SEARCH for diabetes in youth study (Abstract #176-OR; Sunday, June 11, 9:30-9:45 a.m. PDT)
  • Reduced burden of hypoglycemia related to dipeptidyl peptidase-4 inhibitor use (Abstract #3-LB; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Factors associated with clinical inertia after metformin monotherapy failure (Abstract #1212-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Impact of a sitagliptin step-therapy program on diabetes medication use (Abstract #1331-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Comorbidity prevalence among patients with established cardiovascular disease and type 2 diabetes (Abstract #1509-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Insulin initiation among patients with type 2 diabetes mellitus and discontinuation of sulfonylureas (Abstract #1677-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Impact of timely treatment intensification on glycemic goal achievement in patients with type 2 diabetes failing metformin (Abstract #1726-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
  • Drug copay and medication adherence in Medicare patients with type 2 diabetes (Abstract #279-OR; Monday, June 12, 8:30-8:45 a.m. PDT)
  • Impact of switching to a high-deductible health plan on diabetes treatment discontinuation (Abstract #280-OR; Monday, June 12, 8:45-9:00 a.m. PDT)

For more information, including a complete list of abstract titles at the meeting, please visit: http://www.abstractsonline.com/pp8/#!/4297/.

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.

Assessment of renal function is recommended prior to initiating JANUVIA (sitagliptin) 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.

Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Tell patients to report development of blisters or erosions while receiving JANUVIA (sitagliptin). If bullous pemphigoid is suspected, JANUVIA should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.

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 more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. 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. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on TwitterFacebookInstagram, 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 2016 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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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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