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Data presented at the American Diabetes Association® (ADA) 72nd Scientific Sessions provided insights for use of linagliptin in adults with type 2 diabetes (T2D) and at high risk of declining renal function
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Ingelheim, Germany and Indianapolis, US, June 09, 2012 - Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced results from a post-hoc analysis that showed linagliptin is associated with improvements in glucose levels and a significant reduction in urinary albumin-to-creatinine ratio (UACR) of 33% (p<0.05) from baseline in patients with T2D and at high risk of declining renal function (some degree of albuminuria at baseline). UACR is a measure of albuminuria in T2D patients with declining renal function.1 Linagliptin is a once-daily tablet that is used along with diet and exercise either as monotherapy or in combination with other treatments, such as metformin or metformin + sulphonylurea, to improve glycaemic control in adults with T2D.2
The post-hoc analysis included 227 T2D patients at high risk of declining renal function from four randomised, 24 week trials who were on stable treatment with one of two types of blood pressure medicines that are the standard treatment for diabetic renal disease – angiotensin-converting enzyme inhibitors (ACEs) or angiotensin receptor blockers (ARBs).1 In addition to a reduction in glucose levels, as measured by a 0.71% change in haemoglobin A1c [HbA1c] versus placebo at 24 weeks, a 29% reduction in UACR was demonstrated with linagliptin versus placebo.1 HbA1c is measured in patients with diabetes to provide an index of blood glucose control for the previous two to three months.
"This analysis is important because approximately 65% of patients living with type 2 diabetes are at risk of declining renal function, which can limit treatment options," said Professor Per Henrik Groop, Division of Nephrology, Helsinki University Central Hospital, Finland. "In this analysis, patients treated with linagliptin showed improvements in blood glucose levels and reduction of albumin in the urine, a sign for renal dysfunction. We will continue to further investigate this area as we recognise the importance of considering declining renal function when treating type 2 diabetes patients."
The primary endpoint in each of these four trials was the reduction in HbA1c levels from baseline at 24 weeks.
Linagliptin (5 mg, once daily) is marketed in the U.S. as Tradjenta™ (linagliptin), in Europe as Trajenta™ (linagliptin), and in other global markets as a once-daily tablet that is used along with diet and exercise either as monotherapy or in combination with other treatments, such as metformin or metformin + sulphonylurea, to improve glyceamic 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). Linagliptin is not approved in combination with insulin. With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.
About the Albuminuria Post-hoc Analysis
In a post-hoc analysis, data from four randomised, double-blind, 24-week, placebo-controlled trials of linagliptin monotherapy, linagliptin with add-on to metformin, linagliptin with add-on to metformin and sulphonylurea and a factorial study of linagliptin in initial combination with metformin were pooled (n=2472) to explore the clinical effect of linagliptin on albuminuria in patients with T2D who are at high risk of declining renal function (including albuminuria at baseline). The primary objective of these four trials was to analyse the change in HbA1c from baseline at 24 weeks.1
UACR was collected in the four trials as safety data. The endpoint was the percentage change in geometric mean UACR. In this analysis, 492 (19.9%) patients met UACR (30≤UACR ≤3000 mg/g creatinine) and estimated glomerular filtration rate (eGFR) thresholds (eGFR >30 ml/ min/1.73m2) of whom 46% received stable ACE/ARB therapy (linagliptin n=168; placebo n=59). Mean baseline HbA1c and median UACR were 8.2% versus 8.5% and 76 versus 78 mg/g creatinine for the linagliptin and placebo groups, respectively. After 24 weeks, placebo-corrected changes in HbA1c and FPG were -0.71% and -26 mg/dL respectively (both p<0.0001). Linagliptin significantly lowered UACR by 33% compared to baseline (p<0.05) with a between-group difference of -29% (p<0.05).1
An estimated 366 million people worldwide have type 1 and type 2 diabetes.3 Type 2 diabetes is the most common type, accounting for an estimated 90 to 95% of all diabetes cases.4 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.5
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 four pipeline 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 145 affiliates and more than 44,000 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.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. 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 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
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 organizations. 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 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.
1BI/Lilly Data. Groop P, Cooper M, et al. Linagliptin Lowers Albuminuria on Top of Recommended Standard Treatment for Diabetic Nephropathy. Poster No. 953-P. Presented at the American Diabetes Association® (ADA) 72nd Scientific Sessions. June 8-12, Philadelphia, PA.
2Tradjenta™ (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011.
3International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden. 2011. http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed on: April 11, 2012.
4Centers for Disease Control and Prevention.Prevention. National diabetes fact sheet:
national estimates and general information on diabetes and prediabetes in the
United States, 2011. Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, 2011.
5International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 11, 2012.