Phase III safety and efficacy data of Trajenta® (linagliptin) in elderly people with Type 2 Diabetes published in The Lancet

Phase III safety and efficacy data of Trajenta® (linagliptin) in elderly people with Type 2 Diabetes published in The Lancet

Linagliptin demonstrated clinically important HbA1c reduction, safety and tolerability profile in elderly people with Type 2 Diabetes with inadequate glycaemic control

Ingelheim, Germany and Indianapolis, US, 15 August 2013 – Data published in The Lancet showed that elderly people with Type 2 Diabetes (T2D) treated for 24 weeks with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, marketed by Boehringer Ingelheim and Eli Lilly and Company, experienced significant reductions in blood glucose levels (HbA1c) compared with those receiving placebo. In addition, the overall safety and tolerability profile of linagliptin was similar to placebo, with no significant difference in hypoglycaemia.1

"Elderly individuals comprise approximately 15% of people with Type 2 Diabetes2; however, few glucose-lowering agents have been investigated in this group. This evidence gap hinders clinical decision-making as the risks and benefits of treatment may be unclear," said Professor Anthony H. Barnett, MD, FRCP, Heart of England NHS Foundation Trust and University of Birmingham, United Kingdom. "This study may inform treatment decisions for improving individualised glycaemic goals in the elderly."

The publication reports on a 24-week, double-blind, parallel-group, multinational, Phase III study in 241 elderly people (≥70 years) with T2D randomised to receive linagliptin 5mg (n=162) or placebo (n=79), in addition to existing glucose-lowering drugs (i.e. metformin and/or sulphonylurea and/or basal insulin). The primary endpoint was change in HbA1c from baseline to week 24. Key results from the study showed that the placebo-adjusted mean change from baseline in HbA1c with linagliptin was −0.64 percent (p<0.0001) after 24 weeks, which showed superiority versus placebo for the primary endpoint. In addition, the placebo-adjusted mean reduction in fasting plasma glucose from baseline with linagliptin was −1.15 mmol/L (p<0.0001).

The percentage of people reporting adverse events was the same in both treatment groups (75.9 percent). Common adverse events included hypoglycaemia (22.8 percent and 16.5 percent for linagliptin and placebo, respectively), nasopharyngitis (10.5 percent in the linagliptin arm and 8.9 percent on placebo), diarrhoea (5.6 percent in the linagliptin arm and 2.5 percent on placebo), and hyperglycaemia (5.6 percent and 10.1 percent for linagliptin and placebo, respectively). Drug-related adverse events leading to discontinuation of the study drug was the same in both treatment groups (one patient per group).

"This study provides much-needed data on glucose-lowering treatment of elderly people with Type 2 Diabetes, inadequately controlled with common anti-hyperglycaemic agents," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The results support linagliptin's efficacy and safety profile in these patients, a prevalent population for which many other treatment options may have important limitations."

About the study
The study was conducted at 33 centres in five countries (Australia, Canada, Denmark, The Netherlands and Sweden). A total of 241 people who were ≥70 years with T2D , had HbA1c of ≥7.0 percent and received metformin and/or sulphonylurea and/or basal insulin were randomised 2:1 to once-daily oral treatment with linagliptin 5mg or placebo for 24 weeks.

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 people with Type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). 3,4

About Diabetes
An estimated 371 million people worldwide have Type 1 or Type 2 Diabetes;5 approximately one quarter of whom are aged ≥ 65 years.2 Type 2 Diabetes is the most common type, accounting for an estimated 90-95 percent of all diabetes cases.6 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.7

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 percent 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.

References
1Barnett A et al. Treatment of elderly patients (≥70 years) with Type 2 Diabetes inadequately controlled on common anti-diabetes therapies: A randomised, double-blind, placebo-controlled trial with the dipeptidyl peptidase-4 inhibitor linagliptin. Lancet. 2013 Aug 13. Doi: pii: S0140-6736(13)61693-1 [Epub ahead of print]
2Merck Manuals; Hormonal and Metabolic Disorders; Diabetes Mellitus; Accessed online: 29 July 2013
3Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011
4EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011
5International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden (2012 Update - 5th Edition).
6Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited 2013 January 2013]; Available from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html#
7International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. 2011; (5th Edition)

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