Actualizado 06/06/2009 19:03 CET
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New Data From Boehringer Ingelheim's Ongoing Linagliptin Trial Programme Show Promising Safety and Efficacy Results (1)


- The addition of linagliptin to metformin treatment for 12 weeks
resulted in clinically relevant and statistically significant
reductions in HbA1c and FPG levels (p-values of less than 0.05%).
- All doses of linagliptin showed superior HbA1c reduction
compared to metformin alone after treatment for 12 weeks (the
placebo-corrected changes from baseline were -0.40% for the 1
mg dose, -0.73% for the 5 mg dose, and -0.67% for the 10 mg dose).
Statistically significant reductions in mean HbA1c levels with
linagliptin 5 mg and 10 mg compared with metformin alone
(both p greater than 0.001) were observed already from week four
onwards.
- In addition, all linagliptin doses showed significant reductions
in FPG levels compared with metformin alone (the placebo-corrected
mean changes from baseline were -19.2 mg/dL for 1 mg, -34.7 mg/dL
for 5 mg, and -29.0 mg/dL for 10 mg).
- In the open-label comparator arm, the placebo-corrected mean
change from baseline in HbA1c was -0.90%.
- The predefined efficacy criterion of more than 80% DPP-4 inhibition in
more than 80% of patients was reached with the 5 mg and 10 mg
linagliptin doses, but not with the 1 mg dose, which fully supports the
5mg dose as optimal dosage.
- HbA1c reductions of greater than or equal to 0.5% were achieved in 44%
to 53% of patients on linagliptin, but only in 13% of the patients
receiving metformin alone.
- Linagliptin had a placebo-like safety/tolerability profile.
The incidence of adverse events was similar in all treatment
groups. No dose relationship of adverse event was observed
- No cases of hypoglycaemia were recorded in the linagliptin groups,
whereas three hypoglycaemic episodes were reported in the
glimepiride group.

INGELHEIM, Germany, June 6 /PRNewswire/ --

Linagliptin is the most advanced compound for the treatment of Type 2 diabetes within Boehringer Ingelheim's diabetes portfolio. Linagliptin belongs to the class of DPP-4 inhibitors and is being developed as an oral once-daily tablet. It is currently in phase III clinical development.

Please be advised: This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

Notes to Editor:

About the Boehringer Ingelheim diabetes pipeline

Metabolism is one of Boehringer Ingelheim's core R&D areas and diabetes is one of the indications at the centre of interest within the company's global research network. As a result, Boehringer Ingelheim is pursuing various modes of action. The company's most advanced compounds targeting Type 2 diabetes are linagliptin (planned trade name Ondero), an oral once-daily tablet which belongs to the novel class of dipeptidylpeptidase (DPP-4)inhibitors and is currently in Phase III development, and a compound in Phase II which belongs to another class of novel antidiabetics, the sodium-dependent glucosetransporter-2 (SGLT-2) inhibitors.

About Diabetes and Type 2 Diabetes

There are approximately 246 million people with diabetes in the adult population.(2a) The International Diabetes Federation estimates the number of people with diabetes will increase to 380 million people worldwide by 2025. (2a) Some 3.8 million men and women worldwide were estimated to have died from diabetes-related causes in the year 2007. This is more than 6% of the total world mortality.(2b)

Type 2 diabetes is the most common type of diabetes accounting for up to 95% of all diabetes cases in the developed world.(2a) Type 2 diabetes rates continue to increase and patients continue to be burdened by serious diabetes-related complications, (2a) also reflected in the fact that approximately 50% of people with diabetes die of cardiovascular disease, and more than 10% die of renal failure.(3) Traditional therapies have frequently failed to meet the demands of today's Type 2 diabetes landscape and new, effective and tolerable treatments are required.

To address this unmet need, Boehringer Ingelheim is committed to researching and developing new compounds in this disease area.

HbA1c = The erythrocyte haemoglobin becomes irreversibly glycosylated in proportion to circulating glucose concentrations, and the resultant product is commonly referred to as haemoglobin A1c (HbA1c). Because of the half-life of the erythrocyte, the percentage of haemoglobin represented by HbA1c provides an index of the average plasma glucose concentration during the previous two to three months.(4)

FPG = Fasting plasma glucose is the level of glucose in blood after an overnight fast.(5)

About Boehringer Ingelheim

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