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

Ingelheim, Germany and Indianapolis, US, 22 June 2013 - Boehringer Ingelheim and Eli Lilly and Company today 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/min/1.73m2). 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

About Diabetes
An estimated 371 million people worldwide have Type 1 and Type 2 Diabetes.⁴ Type 2 Diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.⁵ Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.⁶

Boehringer Ingelheim and Eli Lilly and Company​
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on three compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world’s leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly’s innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.boehringer-ingelheim.com

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions - from medicines to support programs and more - to make lives better. For more information, visit www.lillydiabetes.com

This press release contains forward-looking statements about linagliptin tablets for the treatment of Type 2 Diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that linagliptin will prove to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.