"Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) approved JANUMET?, the first and only tablet combining a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (also known as JANUVIA?), and metformin for the treatment of type 2 diabetes. "

" JANUMET has been approved, as an adjunct to diet and exercise, to improve blood sugar (glucose) control in patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin. JANUMET should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. "

" The FDA approved JANUMET based upon clinical data including sitagliptin plus metformin as separate tablets. A clinical bioequivalence study has demonstrated the equivalence between JANUMET and sitagliptin plus metformin as separate tablets. "

" "JANUMET is the latest advance in Merck's longstanding commitment to developing effective medicines for type 2 diabetes," said Adam Schechter, president, United States Human Health, Merck & Co., Inc. "With JANUMET and JANUVIA, Merck now has a growing family of products that provides physicians with more treatment options for patients with type 2 diabetes." "

" HbA1c is a measure of a person's average blood glucose over a two- to three-month period. "

" A 24-week, randomized, double-blind, placebo-controlled study with 701 patients with mildly to moderately elevated HbA1c levels (mean baseline 8.0 percent) inadequately controlled on metformin, showed that patients taking JANUMET2 (n=453) experienced significant additional mean placebo-subtracted reductions in HbA1c of 0.7 percent beyond that achieved by patients who continued on metformin alone (n=224) (p<0.001). In the study, more than twice as many patients on JANUMET (213 of 453 patients, or 47 percent) reached the American Diabetes Association's HbA1c goal of <7 percent compared with patients on metformin alone (41 of 224 patients, or 18 percent) (p<0.001). "

" JANUMET combines two agents with proven ability to deliver significant improvements in glycaemic control: metformin, a commonly used effective glucoselowering agent, and sitagliptin, a DPP-4 inhibitor that provides significant HbA1c lowering as monotherapy and as add-on therapy to metformin or thiazolidinediones (TZDs) based on clinical trials. JANUMET, like metformin, is dosed twice daily with meals. Consistent with the labeling for metformin alone, the labeling for JANUMET contains a boxed warning for lactic acidosis, a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with JANUMET. "

" "Physicians use several different medications in combination to address the multiple defects associated with type 2 diabetes, however, less than half of patients achieve and maintain their goal HbA1c levels," said Nir Barzilai, M.D., professor of Medicine and Molecular Genetics, director of the Institute for Aging Research, Albert Einstein College of Medicine. "JANUMET is an important new treatment option for many patients who need more than one therapy to control their type 2 diabetes because it addresses all three key defects of type 2 diabetes for improved glycaemic control." "

"Patients treated with JANUMET experienced weight loss comparable to metformin alone, with no increased risk of hypoglycaemia, edema, or GI disturbances beyond metformin alone"

" As clinicians select agents to add to the treatment regimens of patients with uncontrolled type 2 diabetes, it is important to consider issues such as weight gain, hypoglycaemia, edema, and gastrointestinal disturbances. "

" 2 Clinical data referenced in this press release for JANUMET were from studies including sitagliptin plus metformin as separate tablets. A clinical bioequivalence study has demonstrated the equivalence between JANUMET and sitagliptin plus metformin as separate tablets. "

" In a 24-week study, mean body weight decreased 1.5 lb (n=399) in patients taking JANUMET, similar to patients taking metformin alone (1.3 lb decrease; n=169). There was no increased risk of hypoglycaemia in patients treated with JANUMET (1.3 percent vs. metformin alone, 2.1 percent) and no increased risk of edema in patients treated with JANUMET (0.9 percent vs. metformin alone, 1.3 percent). In addition, there was no significant increase in the incidence of overall gastrointestinal adverse reactions in patients treated with JANUMET (11.6 percent vs. metformin alone, 9.7 percent). Specific gastrointestinal adverse reactions included diarrhea (JANUMET, 2.4 percent vs. metformin alone, 2.5 percent), abdominal pain (JANUMET, 2.2 percent vs. metformin alone, 3.8 percent), nausea (JANUMET, 1.3 percent vs. metformin alone, 0.8 percent), and vomiting (JANUMET, 1.1 percent vs. metformin alone, 0.8 percent). The most common adverse experience in sitagliptin monotherapy reported regardless of investigator assessment of causality in =5 percent of patients and more commonly than in patients given placebo was nasopharyngitis. "

" Clinicians should be mindful that hypoglycaemia could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol. Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycaemic effects. "

"By incorporating the novel mechanism of DPP-4 inhibition, JANUMET uniquely addresses the three key defects of type 2 diabetes"

" With the two active components, sitagliptin and metformin, JANUMET has a comprehensive mechanism of action that targets all three key defects of type 2 diabetes for improved glycaemic control: diminished insulin release, uncontrolled production of glucose, and insulin resistance. "

" The sitagliptin component in JANUMET address two of the three key defects that cause poor glucose control: diminished insulin release due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction. By inhibiting the DPP-4 enzyme, sitagliptin significantly increases the levels of active incretin hormones, increasing the synthesis and release of insulin from the pancreatic beta cells and decreasing the release of glucagon from the pancreatic alpha cells. "

" JANUMET also contains metformin, which addresses the other key defect: insulin resistance. Metformin improves insulin sensitivity by increasing uptake and utilization of glucose by the muscles and tissues of the body. Metformin also decreases hepatic glucose production in a manner that is complementary to sitagliptin. "

"JANUMET provides powerful HbA1c lowering through combined reductions of both post- prandial glucose and fasting plasma glucose "

" JANUMET has been demonstrated to provide 24-hour glucose response -at mealtimes, between meals and overnight. In a 24-week, placebo-controlled study of patients with inadequate glycaemic control on metformin alone, JANUMET significantly reduced post prandial, or post-meal, glucose (PPG) levels beyond metformin alone by a mean of 51 mg/dL in patients with a mean baseline 2-hour PPG of 275 mg/dL (n=387, p<0.001) and fasting plasma glucose levels (FPG) beyond metformin alone
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