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FDA Okays Sitagliptin (Januvia)-Metformin Combo Tablet


ROCKVILLE, Md. -- The FDA has approved the first type 2 diabetes treatment that includes a dipeptidyl peptidase-4 (DPP-4) inhibitor with metformin in a single tablet.

ROCKVILLE, Md., April 3 -- The FDA has approved the first type 2 diabetes treatment that includes a dipeptidyl peptidase-4 (DPP-4) inhibitor with metformin in a single tablet.

Called Janumet, the new product combines sitagliptin (Januvia) and metformin, and was indicated by the FDA for type 2 patients who have not achieved adequate glucose control with either agent as monotherapy and who are responsive to sitagliptin and metformin separately.

In a 24-week, randomized, double-blind, placebo-controlled study with 701 patients who had mean baseline hemoglobin A1c levels of 8%, adding the sitagliptin-metformin combination on top of metformin monotherapy decreased HbA1c by an average of 0.7% versus metformin plus placebo (P<0.001).

In the study, more than twice as many patients on combination therapy (213 of 453 patients, or 47%) reached the American Diabetes Association's HbA1C goal of less than 7% compared with patients on metformin alone (41 of 224 patients, or 18%) (P<0.001).

A statement from Merck, which markets sitagliptin and the combination, noted that patients in the clinical trial received the combination as separate tablets. The company said a clinical bioequivalence study has demonstrated the equivalence between the combination tablet and sitagliptin plus metformin as separate tablets.

The combination achieved weight loss similar to that observed in patients taking metformin alone (1.5 pounds for the combination versus 1.3 pounds for metformin monotherapy).

There was also no increased risk of hypoglycemia or edema between the two treatments.

In addition, there was no significant increase in the risk of overall gastrointestinal adverse reactions in patients treated with sitagliptin-metformin (11.6 % versus 9.7%).

Consistent with the labeling for metformin alone, the combination is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis. Sitagliptin-metformin should not be used in patients with type 1 diabetes.

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