(1888PressRelease)
June 09, 2009 - In separate post-hoc analyses, data pooled from studies of 104 weeks in duration showed JANUVIA™ (sitagliptin), when taken alone (two studies) or in combination with metformin (two studies), provided significant blood sugar lowering, which was sustained over two years.
JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients 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. JANUVIA and JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The labeling for both JANUVIA and JANUMET state that they have not been studied in combination with insulin.
"In this study, initial combination therapy with the fixed-dose combination JANUMET for the treatment of type 2 diabetes helped patients achieve blood sugar goals more effectively than metformin alone," said Barry J. Goldstein, M.D., Ph.D., vice president of Clinical Research, Diabetes and Obesity, Merck & Co., Inc. (MRK, NYSE). "For physicians who treat patients who need to lower their blood sugar levels, this may be useful information."
Initial combination therapy or maintenance of combination therapy may not be appropriate for all patients. These management options are left to the discretion of the physician.
JANUVIA is a selective, once-daily DPP-4 inhibitor that enhances a natural body system called the incretin system to help regulate blood sugar by increasing levels of active GLP-1 and GIP hormones. JANUVIA inhibits DPP-4 over 24 hours. JANUMET is a fixed dose combination of JANUVIA and metformin, which targets all three key defects of diabetes: insulin deficiency from pancreatic beta cells, insulin resistance, and overproduction of glucose by the liver. JANUVIA is the first approved compound in the DPP-4 inhibitor class of oral treatments. It has been approved in over 80 countries and to-date, there have been more than 11 million prescriptions dispensed for JANUVIA worldwide.
JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. JANUMET is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis. 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.
As is typical with other anti-hyperglycemic agents used in combination with a sulfonylurea, when sitagliptin is used in combination with a sulfonylurea, a class of medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia.
Initial therapy with JANUMET compared with metformin alone
This large, randomized, double-blind study of initial therapy with JANUMET, a fixed dose combination of sitagliptin and metformin, compared to metformin alone, included 1,250 drug-naïve patients with a mean A1C¹ baseline of 9.8 percent. Patients were randomized to JANUMET (sitagliptin/metformin 50/1,000 mg twice daily) or metformin (1,000 mg twice daily) for 44 weeks. The primary study hypotheses were addressed after 18 weeks. After 18 weeks, patients taking JANUMET as initial therapy achieved mean A1C reductions from baseline of 2.4 percent (n=560), compared with 1.8 percent for patients taking metformin alone (n=566), a significant between-group difference of 0.6 percent (p
###
