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FDA Approves JANUMET™ – DPP-4 Inhibitor And Metformin In A Single Tablet

Merck & Co., Inc. announced 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.

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.

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).

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

By incorporating the novel mechanism of DPP-4 inhibition, JANUMET uniquely addresses the three key defects of type 2 diabetesWith 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 glycemic 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 by a mean of 25 mg/dL in patients with a mean baseline FPG of 170 mg/dL (n=454, p<0.001).

JANUMET is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult 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. Consistent with the labeling for metformin alone, JANUMET is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis. JANUMET should not be used in patients with type 1 diabetes.

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