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New data about the safety and efficacy of linagliptin in adults with type 2 diabetes who have moderate to severe renal impairment presented at ADA
Date:6/22/2013

tension period, patients initially randomized to placebo were switched to glimepiride 1-4 mg once daily and treatment continued in both groups to week 52 (n=107, linagliptin 5 mg and n=114, glimepiride 1-4 mg). The primary endpoint was the reduction in HbA1c levels from baseline at 12 weeks. Mean HbA1c levels at baseline were 8.08 percent for the linagliptin group and 8.03 percent for the placebo/glimepiride group.

Key results from the study showed:

  • Greater mean reduction from baseline HbA1c at 12 weeks for patients treated with linagliptin vs. placebo (-0.53 percent vs. -0.11 percent, respectively; treatment difference –0.42 percent, 95 percent CI -0.60, -0.24; p<0.0001)
  • In the 40-week extension, the change in mean HbA1c was similar for linagliptin and glimepiride
  • Over the extension period, there was less hypoglycemia with linagliptin vs. glimepiride-treated patients (57.9 percent vs. 69.3 percent)

Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily 5mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take linagliptin. Linagliptin is a DPP-4 inhibitor that does not require dose adjustment, regardless of declining renal function or hepatic impairment.

What are TRADJENTA tablets?
TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis
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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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