Boehringer Ingelheim, Lilly released results of new meta-analysis regarding CV events in linagliptin Phase 3 trials presented at the American Diabetes Association

Ingelheim, Germany and Indianapolis, US, 1-7-2013 — /europawire.eu/ — Boehringer Ingelheim and Eli Lilly and Company today announced results from a new analysis of Phase III data demonstrating that treatment with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin is not associated with an increased risk of cardiovascular events in the treatment of Type 2 Diabetes (T2D), versus a number of comparators (placebo, glimepiride and voglibose). These findings were presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®.¹

“There is a well-established association between cardiovascular events and Type 2 Diabetes,” said Dr. Odd Erik Johansen, MD, PhD and, Senior Clinical Programme Leader, Boehringer Ingelheim. “In fact, CV events rank as the major cause of death in patients with diabetes, accounting for more than 50% of all diabetes fatalities. It is therefore important to identify treatments that do not increase the risk of CV events even further.”

The post-hoc analysis pooled results from 19 double-blind studies, included data from 9,459 patients treated with either linagliptin (5mg: 5,687, 10mg: 160) or a composite of placebo and other oral antihyperglycemic treatments (placebo: 2,675, glimepiride: 775, voglibose: 162). The cumulative patient exposure (the sum total of the length of time all patients have been exposed to either group) was 4,421 patient years in patients treated with linagliptin and 3,255 years in the composite group.

The primary endpoint of the pooled analysis was a composite of CV death, non-fatal stroke, non-fatal myocardial infarction (MI) and hospitalisation for unstable angina pectoris (UAP).

Results of the safety analysis showed fewer reported primary events in the linagliptin group versus the composite treatments (60 events in 5,847 patients vs. 62 events in 3,612 patients). This gave a lower incidence rate of 13.4 per 1,000 patient years for linagliptin compared to 18.9 per 1,000 patient years for the total comparator-treated patients as well as a lower hazard ratio of 0.78 (CI: 0.55,1.12, p = NS).¹

The long-term impact of treatment with linagliptin and glimepiride on CV morbidity and mortality is being investigated in the CAROLINA (CARdiovascular Outcome Study of LINAgliptin Versus Glimepiride in Early Type 2 Diabetes) study. CAROLINA is the only ongoing long-term cardiovascular outcome trial of a DPP-4 inhibitor versus a single active comparator (glimepiride). Announced during the ADA congress, the baseline patient characteristics for the 6,103 patient study showed that the recruited patient population is reflective of the target population with early T2D and an increased risk for CV events.² Results from the double-blind, double dummy, event driven trial are expected in 2018.

The CAROLINA patient characteristics include:²

33.7% of recruited patients have previous CV complications
Diabetes duration is <5 years in 41%, 5 – 10 years in 28%
Baseline HbA1c was 7.2% with 72.5% having HbA1c <7.5%
67.3% were on 1 and 22.3% were on 2 glucose-lowering agents (89.1% of patients receiving metformin)
Population was confirmed overweight/obese with BMI <30 kg/m2 in 46% of participants

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 sulphonlyurea, and as add-on therapy to insulin. In the US, linagliptin is also approved for use in this population with sulphonylurea, and pioglitazone.³ With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.³^,⁴

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).3,4

About Diabetes
An estimated 371 million people worldwide have type 1 and T2D.⁵ T2D is the most common type, accounting for an estimated 90% 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 Ingelheimand 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.

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.

References
¹Johansen OE et al, Cardiovascular (CV) safety of linagliptin in patients with Type 2 Diabetes (T2D): A pooled comprehensive analysis of prospectively adjudicated CV events in Phase 3 studies. Oral Presentation No: 376-OR. Presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®. June 21-25, Chicago, IL.
²Marx N. et al,Baseline characteristics of participants enrolled in the CARdiovascular Outcome Study of LINAgliptin Versus Glimepiride in Early Type 2 Diabetes (CAROLINA). Abstract 1931. Presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®. June 21-25, Chicago, IL.
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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