WHITEHOUSE STATION, N.J., June 25, 2011 In a new post-hoc analysis based on the American Association of Clinical Endocrinologists (AACE/ACE) diabetes algorithm presented at the American Diabetes Association (ADA) 71st Annual Scientific Sessions, significantly more patients with type 2 diabetes treated with JANUMET (sitagliptin/metformin HCl) tablets achieved blood sugar goals after 18 weeks compared to metformin as initial therapy.
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 of developing pancreatitis while taking JANUMET.
"Close to half of all patients with type 2 diabetes have not achieved adequate blood sugar control, and patients often require combination therapy to reach blood sugar goals," said Barry J. Goldstein, M.D., Ph.D., Vice President and Therapeutic Area Head, Diabetes and Endocrinology, Merck Research Laboratories. "The results of this post-hoc analysis provide additional data regarding the use of combination therapy with JANUMET for appropriate patients."
"The incidence of type 2 diabetes continues to rise in the U.S. and globally, and it is important to help patients achieve blood sugar goals," said Helena Rodbard, M.D., endocrinologist and former AACE president and Co-Chair of the Algorithm Task Force. "It is critical for physicians to work with patients to develop a personalized diabetes treatment plan in accordance with guidelines, such as the AACE/ACE diabetes treatment algorithm."
Sitagliptin, a component of JANUMET, enhances the body's own ability to lower blood sugar levels by increasing the levels of active incretins, i.e., GLP-1 and GIP. In combining the DPP-4 inhibitor sitagliptin with the most commonly used first-line treatment, metformin, JANUMET targets all three key defects of diabetes: insulin deficiency from pancreatic beta cells, insulin resistance, and overproduction of glucose by the liver.
JANUMET is contraindicated in patients with renal disease or renal dysfunction (serum creatinine levels greater or equal to 1.5 mg/dL in males and greater or equal to 1.4 mg/dL in females) or abnormal creatinine clearance; acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma; or history of a serious hypersensitivity reaction to JANUMET or sitagliptin (one of the components of JANUMET), 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.
There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis.
When sitagliptin was used in combination with a sulfonylurea or insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or insulin. Therefore, patients also receiving insulin or an insulin secretagogue (eg, sulfonylurea) may require a lower dose of insulin or the insulin secretagogue 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, observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue JANUMET and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUMET.
About the Study and Post-Hoc Analysis
A post-hoc analysis of a large, randomized, double-blind study comparing initial therapy with JANUMET to initial therapy with metformin in patients with type 2 diabetes with an A1C of greater than or equal to 7.5 percent was conducted to examine A1C goal attainment based on stratified A1C categories of the AACE/ACE diabetes treatment algorithm.
The original study included 1,250 patients with a mean A1C baseline of 9.9 percent. Patients were uptitrated to JANUMET (sitagliptin/metformin 50/1,000 mg twice daily) or metformin (1,000 mg twice daily). The primary efficacy endpoint of the study was A1C change from baseline at 18 weeks. At week 18, patients taking JANUMET achieved mean A1C reductions of 2.4 percent from a baseline of 9.9 percent, compared with 1.8 percent from a baseline of 9.8 percent for patients taking metformin alone, for a between-group difference of 0.6 percent (p< 0.001).
In the post-hoc analysis, nearly half (48.6 percent) of patients with a baseline A1C between 7.5 and 9.0 percent who initiated therapy with JANUMET achieved the AACE/ACE A1C goal of less than or equal to 6.5 percent at Week 18 compared with 23.1 percent of patients who initiated metformin monotherapy (p< 0.001). Patients in this baseline group taking JANUMET as initial therapy achieved mean A1C reductions from baseline of 1.5 percent (n=183), compared to 1.0 percent with metformin alone (n=182).
In patients with a baseline A1C of greater than 9.0 percent, 24.0 percent achieved the A1C goal of less than or equal to 6.5 percent taking JANUMET as initial therapy, compared with 12.8 percent taking metformin alone (p< 0.001). Patients in this baseline group taking JANUMET as initial therapy achieved mean A1C reductions from baseline of 3.0 percent (n=341), compared to 2.3 percent with metformin alone (n=345).
In patients with a baseline A1C of less than or equal to 7.5 percent, 68.6 percent achieved the A1C goal of less than or equal to 6.5 percent taking JANUMET as initial therapy, compared with 40.5 percent taking metformin alone (p< 0.01). Patients in this baseline group taking JANUMET as initial therapy achieved mean A1C reductions from baseline of 0.9 percent (n=35), compared to 0.7 percent with metformin alone (n=37).
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