Value through Innovation23 April 2014
24 September 2013

Data presented at EASD support safety profile of Trajenta® (linagliptin) in broad range of adults with Type 2 Diabetes

• Pooled analysis of trial data showed linagliptin was well tolerated including in the elderly with normal renal function to severe renal impairment
• The overall incidence of adverse events was similar for linagliptin compared to placebo

Ingelheim, Germany and Indianapolis, US, Wednesday 24th September 2013 - Boehringer Ingelheim and Eli Lilly and Company today announced that results from two different pooled analyses of clinical studies support previous observations that the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin was shown to be well tolerated in a broad range of adults with Type 2 Diabetes (T2D). These data were presented at the 49th European Association of Diabetes (EASD) Annual Meeting.

General safety analysis
Findings from a pooled comprehensive analysis of safety data in 22 linagliptin clinical trials with 7,400 people with T2D (4,810 received linagliptin, 2,590 received placebo) included the following:1

  • Linagliptin was well tolerated overall and across all age groups studied, with a low incidence of hypoglycemic events
  • In an exploratory analysis, overall hypoglycaemia was lower for linagliptin compared to placebo (11.5 percent versus 14 percent, p=0.0021)
  • Overall incidence of adverse events (AE) or serious adverse events (SAE) with linagliptin was similar to placebo (AE 56.5 percent versus 61.2 percent, and SAE 4.8 percent versus 6.3 percent, respectively)
  • The incidence of AEs with linagliptin compared to placebo remained similar irrespective of the age category (≤65 years, 65-74 years, ≥75 years)
Prof. Nikolaus Marx, Professor of Medicine and Cardiology, University Hospital of Aachen, Germany

Prof. Nikolaus Marx

"Drug tolerability is an important consideration in the selection of appropriate treatments for people with Type 2 Diabetes, as often different populations will have drug contraindications and require dose adjustments to manage their disease," said Prof. Nikolaus Marx, Professor of Medicine and Cardiology, University Hospital of Aachen, Germany. "The results presented today support the safety profile of linagliptin."

Renal safety in the elderly
Results from a post-hoc analysis of pooled data from seven clinical trials including 1,293 people with T2D aged 65 years or older showed:2

  • Linagliptin was well tolerated providing clinical efficacy in an elderly population with renal function ranging from normal to severe renal impairment
  • Overall renal function was not significantly altered by treatment with linagliptin from baseline to week 24, versus placebo
  • Patients taking linagliptin achieved a HbA1c reduction of -0.6 percent from baseline and −0.8 mmol/L for fasting plasma glucose (both values placebo-corrected)
  • The overall incidence of AEs with linagliptin was similar to placebo (71.3 percent versus 72.8 percent, respectively)
  • Incidence of investigator-defined hypoglycaemia was not higher in patients who received linagliptin compared to those receiving placebo (21.3 percent versus 24.7 percent), with most events occurring in the trials that included a sulphonylurea or basal insulin as background therapy
  • Renal and urinary AEs were experienced by 5.5 percent and 4.3 percent of linagliptin and placebo patients, respectively.
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim

Professor Klaus Dugi

"The data presented from these analyses supplement the already established evidence demonstrating that linagliptin is a well-tolerated treatment for a broad range of people with Type 2 Diabetes," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "This should provide physicians further assurance when treating different patient types with linagliptin."

The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and several other regulatory authorities worldwide have approved linagliptin for the treatment of adults with T2D as monotherapy or in combination with metformin, metformin + sulphonylurea, and as add-on therapy to insulin. With linagliptin, no dose adjustment is required regardless of renal function or hepatic impairment.3,4

About Linagliptin
Linagliptin (5 mg) 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).3,4

About Diabetes
An estimated 371 million people worldwide have Type 1 and Type 2 Diabetes.5 Type 2 Diabetes is the most common type, accounting for an estimated 90 percent of all diabetes cases.6 Diabetes is a chronic disease 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 centres on three compounds representing several of the largest diabetes 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 endeavours.

In 2012, Boehringer Ingelheim achieved net sales of about €14.7 billion. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% 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 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 programmes 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
1Lehrke M et al. Safety and tolerability of linagliptin in 7,400 patients with Type 2 Diabetes: A pooled comprehensive analysis of prospective safety reporting in placebo-controlled studies. Poster No: 986. Presented at the European Association for the Study of Diabetes (EASD), September 23-27, Barcelona
2Patel S et al. Renal safety of linagliptin in elderly patients with Type 2 Diabetes: analysis of pooled patient data from seven Phase III clinical trials. Poster No: 926. Presented at the European Association for the Study of Diabetes (EASD), September 23-27, Barcelona
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
6World Health 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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  • Eli Lilly and Company

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Media contact

  • Boehringer Ingelheim

    Media & PR
    Dr Petra Kienle
    Binger Strasse 173
    55216 Ingelheim am Rhein
    GERMANY

Media contact

  • Eli Lilly and Company

    Communications Manager
    Lilly Diabetes
    Tammy Hull

    • Phone +1 (317) 651-9116