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FDA Approves Tradjenta™ (linagliptin) Tablets for the Treatment of Type 2 Diabetes
Date:5/2/2011

ith TRADJENTA, physicians will have another option for managing type 2 diabetes, a potentially devastating condition."

TRADJENTA 5 mg once daily was approved based on a clinical trial program which included approximately 4,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating TRADJENTA as monotherapy and in combination with the commonly prescribed medications for type 2 diabetes –  metformin, sulfonylurea or pioglitazone. TRADJENTA showed statistically significant A1C reductions of up to 0.7 percent when used as monotherapy (compared to placebo). When used in combination with metformin, sulfonylurea, and metformin plus sulfonylurea, the addition of TRADJENTA resulted in significant A1C reductions of 0.6, 0.5, and 0.6 percent respectively (compared to placebo). In the initial combination of TRADJENTA plus pioglitazone, significant reductions in A1C of 0.5 percent were observed compared to placebo.  

Treatment with TRADJENTA also produced significant reductions in fasting plasma glucose (FPG) compared to placebo, when used as monotherapy and in combination with metformin, sulfonylurea or pioglitazone. Treatment with TRADJENTA produced significant reductions in two-hour post-prandial glucose (PPG) levels compared with placebo as monotherapy and when used in combination with metformin. FPG is used to determine glucose levels in a fasting state (usually upon wakening in the morning), and PPG is used to determine glucose levels after meals (usually two hours after eating).

In controlled studies, change from baseline in body weight did not differ significantly between groups when TRADJENTA was administered as monotherapy, in combination with metformin or in combination with metformin plus sulfonylurea. Patients treated with TRADJENTA exhibited a significant mean decrease from baseline body weight compared to a significant weight gain in patients administered sulfonylurea (-1.1 kg vs. +1.4 kg
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company
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