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Linagliptin demonstrates meaningful improvement in glycaemic control in initial combination therapy with metformin
 
 
  Additional data on linagliptin monotherapy shows durable glucose control with a low risk of hypoglycaemia

EX US, UK and UAE Medical Media Only. Under embargo until 08 Dec, 10 am CET

Ingelheim, Germany and Indianapolis, US, 8 December 2011 - Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced results of a 24-week open label arm of a phase III study for linagliptin in initial combination with metformin, which showed meaningful reductions in blood glucose for adults with Type 2 Diabetes (T2D). 1 Results were presented at the International Diabetes Federation (IDF) World Diabetes Congress in Dubai.

Initial combination therapy of linagliptin with metformin resulted in mean HbA1c reductions of -3.7% in poorly controlled patients after 24 weeks. Treatment was well tolerated with 9% of patients experiencing drug-related adverse events (AE) and only 1.5% of patients reporting hypoglycaemia. 1

"Many patients with high HbA1c levels require more than metformin alone to reach their blood glucose targets. Linagliptin can support patients with Type 2 Diabetes to effectively manage their condition in order reach their blood glucose targets," commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

Furthermore, linagliptin demonstrated durable improvements in glycaemic control with a low risk of adverse events in a 34-week extension phase of a one year monotherapy trial. 2, 3 Linagliptin was compared with glimepiride in T2D patients for whom metformin was inappropriate due to intolerance or contraindication. HbA1c levels in patients treated with linagliptin remained stable from 7.5% at week 18 to 7.4% at week 52. 2 Similar stable efficacy was observed with glimepiride when patients were switched from placebo following completion of the previous 18-week arm of the trial. 2, 3 However, patients within the linagliptin group demonstrated a lower overall number of AEs: 2

· Drug-related AEs were lower with linagliptin (4.4%) compared with glimepiride (7.8%)

· Hypoglycaemia occurred three times less with linagliptin (2.2%) than with glimepiride (7.8%) (statistically significant); no severe episodes occurred in either group

· Body weight remained stable in the linagliptin arm whereas it increased in the glimepiride arm from 82.5 kg to 85.0 kg (statistically significant)

Linagliptin (trade name Tradjenta™ in the US and Trajenta™ in Europe and other global markets) is the only diabetes treatment to be approved at one dosage strength (5 mg, once daily) for all adult patients with T2D without any need for dose adjustment. 4, 5 Unlike other DPP-4 inhibitors, linagliptin is primarily excreted unmetabolised via bile and gut, meaning no dose adjustment is needed in patients with declining kidney or liver function. 4, 5 In addition, an analysis from 8 global phase III trials supports the promising cardiovascular (CV) profile of linagliptin. 6 Primary endpoint was a composite of CV death, nonfatal stroke, nonfatal myocardial infarction, and hospitalisation for unstable angina. The pooled results revealed a 69% reduction of the primary endpoint for patients with the highest baseline Framingham risk score* when treated with linagliptin compared to the respective comparators. 6

The CV safety profile of linagliptin is currently being investigated in 6,000 patients through the CAROLINA trial (Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes). 7, 8

"The CAROLINA trial has a unique design, in that it is the first CV outcome study in the DPP-4 class to include an active comparator," said Robert Heine, M.D., Vice President of Medical Affairs, Lilly Diabetes. "It is part of our joint long-term commitment to evaluate the effectiveness of our treatments and will add to the body of knowledge that physicians have to assist them in choosing the most appropriate treatment for their patients."

Notes to editors:

Highlights of clinical studies presented at IDF:

Initial combination of the DPP-4 inhibitor linagliptin with metformin improves poor glycaemic status in patients with Type 2 Diabetes1 http://tinyurl.com/Abstract-O-0617

The aim of this 24-week study was to assess the safety and efficacy of linagliptin plus metformin as initial combination therapy in adult T2D patients with poor glycaemic status. As many patients with T2D do not reach recommended glycaemic control targets due to the current treatment protocol of first undertaking lifestyle interventions then starting monotherapy, an earlier combination therapy may be more appropriate.

1yr linagliptin monotherapy is well tolerated & sustains improvement in glycaemic control in patients for whom metformin is inappropriate2 http://tinyurl.com/Abstract-D-0920

This 34-week double blind extension study was designed to evaluate the efficacy, safety and tolerability of linagliptin monotherapy in patients with inadequately controlled T2D for whom metformin was not tolerated or was contraindicated and where an alternative first line treatment is needed.

Cardiovascular risk with linagliptin in subgroups of p atients with Type 2 Diabetes: Results of a predefined meta-analysis6. http://tinyurl.com/Abstract-P1349

These meta-analysis pooled results from 8 phase III randomised trials and explored the impact of linagliptin vs. comparator on the primary CV endpoint in predefined subgroups. CV events were adjudicated by a blinded independent expert committee. The primary endpoint was a composite of CV death, nonfatal stroke, nonfatal myocardial infarction, and hospitalisation for unstable angina. CV disease is the main cause of death in patients with T2D.

About Diabetes

An estimated 366 million people worldwide have diabetes. 9 Type 2 Diabetes is the most common type, accounting for an estimated 90 percent of all diabetes cases. 10 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.

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 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 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products 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 endeavours. In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24 percent of net sales in its largest business segment Prescription Medicines on research and development. 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 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

For more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. Lilly introduced the world's first commercial insulin in 1923, and remains at the forefront of medical and delivery device innovation to manage diabetes. Lilly is also committed to providing solutions beyond therapy - practical tools, education, and support programmes to help overcome barriers to success along the diabetes journey. At Lilly, the journeys of each person living with or treating diabetes inspire ours. 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 commercialization. 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.

References

1Haak, Meinicke, Jones, et al. Initial Combination of the DPP-4 Inhibitor Linagliptin with Metformin Improves Poor Glycaemic Status in Patients with Type 2 Diabetes. ABSTRACT O-0617

2Patel, Barnett, Harper, et al. 1yr Linagliptin Monotherapy is Well Tolerated & Sustains Improvement in Glycaemic Control in Patients for Whom Metformin is Inappropriate. ABSTRACT D-0920

3Barnett AH, Harper R, Toorawa R, et al. Linagliptin monotherapy improves glycaemic control in type 2 diabetes patients for whom metformin therapy is inappropriate. Poster no. 823-P, 46th European Association for the Study of Diabetes Annual Meeting, September 2010, Stockholm, Sweden.

4Tradjenta™ (linagliptin) tablets. Highlights of Prescribing Information. Initial U.S. Approval: 2011.

5Trajenta™ (linagliptin) tablets. EMA Summary of Product Characteristics. Approval 25 September 2011. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002110/WC500115745.pdf

6Johansen, Neubacher, von Eynatten, et al. Cardiovascular risk with linagliptin in subgroups of patients with type 2 diabetes: Results of a predefined meta-analysis. ABSTRACT P-1349

7ClinicalTrials.gov: www.clinicaltrials.gov/ct2/show/NCT01243424?term=NCT01243424&rank=1. Last accessed: October 2011.Trajenta™ (linagliptin) tablets. EMA Summary of Product Characteristics. Approval 25 September 2011. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002110/WC500115745.pdf

8Rosenstock, Marx, Kahn et al. CAROLINA Trial Rationale and Design: A Long-Term, Active-Comparator, CV Outcomes Study of Linagliptin vs Glimepiride in Type 2 Diabetes. ABSTRACT D-0675a

9International Diabetes Federation: www.idf.org. Last accessed: October 2011. 10World Health Organization: Fact Sheet No. 312 What is Diabetes?, 2010.

* Risk assessment tool for estimating a person's 10-year risk of heart disease using based on findings from a large, long-term study conducted in Framingham, Massachusetts.

 
 
 
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