FDA clears Janumet for type 2 diabetes

US drug major Merck & Co says that the Food and Drug Administration has approved Janumet, which combines a dipeptidyl peptidase-4 inhibitor, sitagliptin and insulin sensitizer metformin, for the treatment of type 2 diabetes.

Specifically, the product has been cleared, as an adjunct to diet and exercise, to improve blood sugar control in diabetic patients who do not respond to metformin and sitagliptin alone. The firm added that the drug should not be used as a treatment for either type 1 diabetes mellitus or diabetic ketoacidosis.

The FDA's approval decision is based on data from a 24week, placebo-controlled study, which demonstrated that the drug allowed 47% of those treated to reach the American Diabetes Association's HbA1c goal, compared with patients who received metformin alone (18%).