Merck announced that Janumet—a single-tablet combination of sitagliptin (Januvia) and metformin—has cleared the FDA.
The new combination is to be used as an adjunct to diet and exercise for improved blood glucose control in adult patients with type 2 diabetes whose glucose levels are not adequately controlled with metformin or sitagliptin alone, or in patients already taking both agents individually.
The drug is the first and only tablet combining a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin. A double-blind, placebo-controlled study showed that more than twice as many patients taking Janumet reached an A1c goal of less than 7% compared with patients on metformin alone.
“Janumet is an important new option for many patients who need more than one therapy because it addresses all three key defects of type 2 diabetes,” said Nir Barzilai, MD, professor of medicine and molecular genetics at the Albert Einstein College of Medicine in New York City.