Boehringer Ingelheim's Diabetes Pipeline Continues to Advance as the Company Announces Conclusion of Robust Phase III Pivotal Trials Programme for linagliptin

Ingelheim, Germany (ots/PRNewswire) -

- For Non-US Healthcare Media

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
haemoglobin A1c (HbA1c)-lowering (-0,73 percent, 5 mg dose) and a
safety profile comparable to placebo.

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
than 4,000 patients in over 40 countries worldwide. The primary
objective of these studies was to evaluate the efficacy and safety
profile of linagliptin alone and in combination with commonly used
diabetes treatments including metformin, sulfonylureas and
thiazolidinediones (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, with Type 2
diabetes being the most common form, accounting for up to 95 percent
of all diabetes cases in the developed world. Each year, more than
3.8 million people worldwide die from diabetes and its complications.

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 (dipeptidyl
peptidase)-4 and inhibition of SGLT (sodium-dependent glucose
transporter)-2. These compounds reflect the Company's dedication to
harnessing the most advanced science to efficiently control Type 2
diabetes and its often fatal consequences.

For full version please visit

http://www.boehringer-ingelheim.com/corporate/news/press_releases
/detail.asp?ID=6935

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For more information about Type 2 diabetes, please also visit

http://www.youtube.com/user/diabetesmatters and

http://www.boehringer-ingelheim-webcast.com/diabetes

ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Ursula Bardon, Corporate Division Communications, Boehringer
Ingelheim GmbH, 55216 Ingelheim/Germany, Phone: +49-6132-77 2622,
Fax: +49-6132-72 2622, E-mail: press@boehringer-ingelheim.com