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Ingelheim/Germany, 28 September 2009 - Following the release of linagliptin Phase II data earlier this year, Boehringer Ingelheim has now announced the conclusion of the linagliptin pivotal Phase III clinical trials. The company confirmed that first results from the Phase III clinical trials programme consistently support the favourable efficacy and safety profile already observed in earlier linagliptin investigational studies, such as the Phase II data which had shown significant results in HbA1c lowering (-0,73 percent, 5 mg dose) and a safety profile comparable to placebo.1
Linagliptin belongs to the class of DPP-4 inhibitors and is being developed as an oral once-daily tablet for patients with Type 2 diabetes. The five pivotal Phase III clinical trials included more that 4,000 patients in over 40 countries worldwide. The primary objective of these studies was to evaluate the efficacy and safety profile o flinagliptin alone and in combination with commonly used diabetes treatments including metformin, sulfonylureas and thiazolinediones(TZDs). The overall linagliptin clinical trials programme includes longer term studies and also studies to assess the safe and efficacious use of linagliptin in Type 2 diabetes patients with renal impairment. Full results from the Phase III trials will be presented at international scientific congresses in 2010 and beyond.
Professor Anthony Barnett, Professor of Medicine and Clinical Director of the Department of Diabetes and Endocrinology, Heart of England NHS Foundation Trust, Birmingham, UK commented, "Every ten seconds a person dies from diabetes-related causes. It can’t be emphasised enough that research needs to focus on treating the condition effectively, avoiding the complications inherent to the condition, and delaying disease progression. Medication needs to be easy to take, with good tolerability, low risk of drug-drug interactions and a low risk of side effects, including weight gain and hypoglycaemia. The DPP-4 inhibitors belong to a newer class of pharmacological treatments which appear to have many advantages over traditional therapies."
"For Type 2 diabetes treatments it is important that these not only help patients to achieve optimal blood glucose levels, but also ensure that the reduction is maintained stable and long-term. Therapies to date have not been able to achieve constant long-term glucose control and, in addition, the traditional combinations have shown an increased risk for side effects, such as hypoglycaemia. Furthermore, it is essential that treatments not only prevent the long-term complications often found in advanced stages of the disease, but also prove to be a therapeutic option in those patients who have developed complications, such as renal impairment," said Professor Klaus Dugi, Head of Corporate Medical Affairs, Boehringer Ingelheim." First data from the Phase III clinical trials programme so far suggest that linagliptin is likely to achieve these goals. The ongoing analyses of the complete set of data obtained from these trials will help to assess the full potential of linagliptin for the treatment of Type 2 diabetes," he added.
Despite significant advances in treatments, the prevalence of Type 2 diabetes continues to rise across the globe. There are approximately 250 million people worldwide with diabetes,2 with Type 2 diabetes being the most common form, accounting for up to 95% of all diabetes cases in the developed world.3 Each year, more than 3.8 million people worldwide die from diabetes and its complications.4
Traditional therapies have frequently failed to meet the demands of today’s Type 2 diabetes landscape and new, effective and tolerable treatments are required. At Boehringer Ingelheim`s largest Research& Development site and the centre of excellence for metabolic diseases in Biberach, Germany, the research teams have been focusing on the discovery and development of oral anti-diabetic treatments targeting new principles, such as the inhibition of DPP-4(dipeptidylpeptidase) and inhibition of SGLT-2 (sodium-dependentglucose transporter). These compounds reflect the Company’s dedication to harnessing the most advanced science to efficiently control Type 2 diabetes and its often fatal consequences.
Notes to editor:
About Diabetes and Type 2 Diabetes
The International Diabetes Federation estimates the number of people with diabetes will increase to 380 million people worldwide by 2025.2 Type 2 diabetes rates continue to increase and patients continue to be burdened by serious diabetes-related complications, also reflected in the fact that approximately 50% of people with diabetes die of cardiovascular disease, and more than 10% die of renal failure.5
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 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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1 DPP-4 inhibitor linagliptin improves glycaemic control in type 2 diabetes patients when added to ongoing metformin therapy. Poster No 535-P, presented at the 69th American Diabetes Association Scientific Sessions, 05-09 June 2009, New Orleans, U.S.A.
2 International Diabetes Federation. Diabetes Atlas. 3rd edn. Brussels: International Diabetes Federation, 2006. Available at: http://www.eatlas.idf.org/index2983.html Accessed on: 1 September, 2009.
3 International Diabetes Federation. Facts & Figures: Prevalence. Available at: http://www.idf.org/diabetes-prevalence. Accessed on: 1 September 2009.
4 International Diabetes Federation. Facts & Figures: Did You Know? Available at: http://www.idf.org/sound_bites Accessed on: 1 September, 2009.
5 Morrish,N.J. et al.. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia.2001; 44 Suppl 2: S14-S21