New data were presented at the American Diabetes Association (ADA) 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone. Patients taking JANUMET also experienced weight loss and a lower incidence of edema or swelling, while patients taking pioglitazone experienced weight gain and a higher incidence of edema. Patients taking JANUMET had a higher incidence of gastrointestinal events compared with pioglitazone.
“These findings support the use of combination therapy with JANUMET for appropriate patients upon diagnosis with type 2 diabetes.”
JANUMET is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET.
"In this study, JANUMET provided greater blood sugar lowering as an initial treatment compared with pioglitazone," said Barry J. Goldstein, M.D., Ph.D., vice president of Clinical Research, Merck Research Laboratories. "These findings support the use of combination therapy with JANUMET for appropriate patients upon diagnosis with type 2 diabetes."
JANUMET is a fixed-dose combination of the DPP-4 inhibitor sitagliptin and metformin, which is the most commonly used first-line treatment. JANUMET targets all three key defects of diabetes: insulin deficiency from pancreatic beta cells, insulin resistance, and overproduction of glucose by the liver. JANUMET has been approved in 79 countries and to date, more than 5 million prescriptions have been dispensed for JANUMET in the U.S. alone.
JANUMET is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma; or history of a serious hypersensitivity reaction to JANUMET or sitagliptin, such as anaphylaxis or angioedema. 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.
When JANUMET was used in combination with a sulfonylurea or insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.
There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUMET. After initiating JANUMET, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, JANUMET should be promptly discontinued and appropriate management initiated. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUMET.
Merck Sharp & Dohme Corp.