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)
Media contact
Boehringer Ingelheim
Media & PR
Dr Ralph Warsinsky
Binger Strasse 173
55216 Ingelheim am Rhein
GERMANY
Phone +49/6132/77 7051
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contact
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Eli Lilly and Company
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Tammy Hull
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- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP