Media & PR
Ute E. Schmidt
Binger Strasse 173
55216 Ingelheim am Rhein
Linagliptin studies also demonstrate meaningful glycaemic control in patients whose blood glucose is inadequately controlled by metformin alone
For Medical Media outside the US and UK only.
Lisbon, Portugal, 16 September, 2011 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced results of a 102 week Phase III study for linagliptin (trade name Trajenta® in Europe), which show meaningful and durable reductions in blood glucose for adults with type 2 diabetes (T2D). In the two-year study presented today at the 47th Annual Meeting of the European Association for the Study of Diabetes (EASD), the DPP-4 inhibitor linagliptin showed a favourable safety profile and lowered HbA1c levels by 0.8% over the long term1 in those patients treated with linagliptin for the full study period.
"These results show that the efficacy achieved by linagliptin is reliable and meaningful in a clinical setting, but also that it is durable over the long term. This is especially important in chronic conditions such as type 2 diabetes," commented Prof. David Owens, Clinical Professor of the Department of Medicine, Cardiff University School of Medicine, Wales, UK.
The data from these patients demonstrate the efficacy and tolerability of linagliptin as mono-, dual- (plus metformin or initial combination with pioglitazone) or triple (plus metformin and sulphonylurea) oral therapy over a period of 102 weeks. Reductions in HbA1c of 0.8% after 24 weeks of blinded treatment were seen to be durable over the additional 78 weeks. Overall, the rate of hypoglycaemic events was low and body weight remained unchanged.2
An additional 12-week study also indicated the efficacy and tolerability of linagliptin as add-on therapy to metformin. In the trial, type 2 diabetes patients uncontrolled with metformin twice daily (≥1500mg/day) were randomised either to linagliptin 2.5mg twice daily (to enable integration with metformin twice daily dosing regimen during this 12-week-study) or linagliptin 5mg approved dose once daily. Results showed comparable placebo-adjusted HbA1c reductions of -0.74% and 0.8% respectively (from a mean baseline HbA1c of 8.0%, p<0.0001). 2
"Linagliptin is a new treatment that is primarily excreted unmetabolised via the bile and gut, and so delivers reliable HbA1c reductions at one dosage strength for all patients, even for those with declining hepatic or renal function," said Prof. Anthony Barnett, Consultant Physician, Heart of England NHS Foundation Trust and Emeritus Professor of Medicine, University of Birmingham, UK. "One dosage strength for all patients will help make the process of prescribing easier and more straightforward for physicians."
The data presented at EASD demonstrate meaningful efficacy of linagliptin with a good safety and tolerability profile across the full spectrum of type 2 diabetes, from newly diagnosed patients to those with severe renal impairment.3
Highlights of Linagliptin Clinical Studies Presented at EASD
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 endeavors.
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.
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 programs 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.
1Schlosser A, Owens D, Taskinen M-R, et al. Long-term safety and efficacy of the DPP-4 inhibitor linagliptin: data from a large 2-year study in subjects with type 2 diabetes mellitus. 47th Annual Meeting of the European Association for the Study of Diabetes. 2011;OP 43.
2Rafeiro E, Ross SA, Meinicke T, et al. Efficacy and safety of 5 mg daily dosing regimens with linagliptin in patients with type 2 diabetes inadequately controlled on metformin. 47th Annual Meeting of the European Association for the Study of Diabetes. 2011;Poster-831.
3Newman J, McGill JB, Patel S, et al. Long-term efficacy and safety of linagliptin in patients with type 2 diabetes and severe renal impairment. 47th Annual Meeting of the European Association for the Study of Diabetes. 2011;Poster-821.
4Patel S, Weber S, Emser A, et al. Linagliptin improves glycaemic control independently of diabetes duration and insulin resistance in patients with type 2 diabetes. 47th Annual Meeting of the European Association for the Study of Diabetes. 2011;Poster-832.
5International Diabetes Federation. 2010: Available from: www.idf.org.
6World Health Organization. Fact sheet N°312. 2011: http://www.who.int/mediacentre/factsheets/fs312/en/.