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Trajenta® (linagliptin): New data on safety and efficacy in Type 2 Diabetes patients with moderate to severe renal impairment


June 24, 2013 - Ingelheim, Germany And Indianapolis, United States

For Non-U.S. and Non-UK media

Boehringer Ingelheim and Eli Lilly and Company has announced results from a new study that demonstrated linagliptin showed statistically significant reduction in blood glucose levels (HbA1C) in adult patients with Type 2 Diabetes (T2D) with moderate to severe renal impairment (RI), compared with those receiving placebo (12 weeks). Most patients had T2D for more than ten years (76%) and were on insulin (86%). After 12 weeks, patients on placebo switched to glimepiride up to 52 weeks. The study found that patients treated with linagliptin had lower rates of hypoglycaemia and less weight gain than those who received glimepiride.1

“These are important findings for physicians managing patients with Type 2 Diabetes and renal impairment, which we are seeing more and more in today’s practice,” said Professor Markuu Laakso, Professor of Medicine at the Department of Medicine, University of Kuopio, Finland. “Approximately half of patients living with Type 2 Diabetes are also at risk of declining renal function, and treatment options for these patients can be limited. Ensuring that optimum blood glucose levels are achieved paired with the prevention of hypoglycaemic events is becoming more of a challenge.”

These new findings were derived from a double-blind trial including 235 T2D patients with moderate to severe RI (estimated glomerular filtration rate <60 ml>2). Patients received linagliptin, 5 mg qd (n=113) or placebo (n=122) for 12 weeks, then placebo patients were switched to glimepiride 1-4 mg qd and treatment continued to week 52.

The primary endpoint was the reduction in HbA1c levels from baseline at 12 weeks.

Key results from the study showed:

  • Greater mean reduction in baseline HbA1c at 12 weeks for patients treated with linagliptin vs. placebo (-0.53±0.06% vs. -0.08±0.07%; p<0.0001)
  • In the 40 week extension, HbA1c was lower with linagliptin vs. glimepiride (difference is not statistically significant)
  • Less frequent hypoglycaemic events experienced with linagliptin vs. glimepiride (57.9% vs. 69.3%)
  • Weight neutrality for linagliptin versus weight gain for patients treated with placebo followed by glimepiride (mean increase after 52 wks 0.06 kg linagliptin vs. 1.74 kg placebo/glimepiride)

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory authorities worldwide approved linagliptin for the treatment of adult patients with T2D as monotherapy or in combination with metformin, with metformin and a sulphonylurea, and as add-on therapy to insulin. With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.2,3

About Linagliptin

Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin), as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. 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).2,3

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/22_june_2013_linagliptin2.html


MULTIMEDIA AVAILABLE : http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50657369&lang=en

CONTACTS : Dr. Ralph Warsinsky Corporate Communications Boehringer Ingelheim GmbH Email: press@boehringer-ingelheim.com Phone: +49 178 290 8561 or Tammy Hull Communications Manager Lilly Diabetes Email: hullta@lilly.com Phone: +1 (317) 651 9116

Source: Business Wire India

BusinessWireIndia

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