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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

RIDGEFIELD, Conn. and INDIANAPOLIS, June 22, 2013 /PRNewswire/ --  Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from a new study in which linagliptin demonstrated statistically significant reductions in blood glucose levels (HbA 1c) after 12 weeks (the study's primary endpoint) in adults with type 2 diabetes (T2D) with moderate to severe renal impairment, compared with placebo. Most patients had T2D for more than ten years (76 percent) and were on insulin (86 percent).

Over an extension period (week 12 to week 52), patients treated with linagliptin had an overall improvement in blood glucose levels that was similar to those patients who had initially received placebo for 12 weeks and were thereafter switched to glimepiride for the remaining 40 weeks. Patients treated with linagliptin had a lower rate of hypoglycemia compared to those treated with glimepiride. 1

"These findings add to the growing body of knowledge for health care providers managing the increasing number of patients with type 2 diabetes and renal impairment," said Christophe Arbet-Engels MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Special considerations should be taken when prescribing treatments for the nearly two-thirds of people living with type 2 diabetes who are at risk of declining renal function."

About the Study These new findings were derived from a double-blinded trial including 235 people with T2D and moderate to severe RI (estimated glomerular filtration rate <60 mL/min/1.73m 2). For analysis of the primary endpoint, patients were randomized to linagliptin, 5 mg once daily (n=113) or placebo (n=122) for 12 weeks. For the 40-week extension 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 HbA 1c levels from baseline at 12 weeks. Mean HbA 1c 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 HbA 1c 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 HbA 1c 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.

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