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Late Breaking Data Released at ADA Showed that the Investigational,Use of Januvia and Metformin as Initial Combination Therapy,Provided Significant Glucose Lowering Efficacy over 54 Weeks in,Patients with Type 2 Diabetes

e patients, 212 were on glimepiride alone (106 each on JANUVIA or placebo), and 229 on glimepiride and metformin (116 on JANUVIA, 113 on placebo). The primary endpoint was A1C change from baseline for the entire cohort.

The addition of JANUVIA to a sulfonylurea with or without metformin was generally well-tolerated in this study. A higher incidence of overall adverse experiences (60 vs. 47 percent) and drug-related adverse experiences (15 vs. 7 percent) were reported with JANUVIA compared to placebo in patients treated with glimepiride with or without metformin. These higher rates were partly related to a higher incidence of hypoglycemia with JANUVIA compared to placebo (12 vs. 2 percent, respectively). The higher rate of hypoglycemia has commonly been seen when antihyperglycemic agents are used in combination with sulfonylurea agents. After 24 weeks, body weight was increased more with JANUVIA than with placebo (mean change from baseline of +0.8 vs. -0.4 kg, respectively; p less than 0.001).

"These new potential uses of sitagliptin as add-on to sulfonylurea, as add-on to sulfonylurea plus metformin, and as initial therapy in combination with metformin, if approved by the FDA, would provide physicians with additional treatment options for patients with type 2 diabetes," said Mark Kipnes, M.D., associate medical director, Diabetes and Glandular Research Associates, and clinical professor of Medicine, University of Texas Health Science Center at San Antonio.

As Merck announced in February, these data have been submitted to the U.S. Food and Drug Administration (FDA) in support of proposed new indications for the use of JANUVIA. One sNDA is filed in support of a proposed new indication for the use of JANUVIA, as an adjunct to diet and exercise, in combination with metformin as initial therapy to improve glycemic control. The other sNDA is filed in support of two proposed new indications for use of JANUVIA, as an adjunct to diet and exercise, as add
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