New Data From Boehringer Ingelheim's Ongoing Linagliptin Trial Programme Show Promising Safety and Efficacy Results


    - Results From Linagliptin Study in Type 2 Diabetes Patients Who Were
    Inadequately Controlled on Metformin Therapy Alone, Presented at Major
    Diabetes Meeting

    INGELHEIM, Germany, June 6 /CNW/ - Study results presented for the first
time in the scientific sessions of this year's American Diabetes Association
Annual Meeting (ADA) show clinically relevant and statistically significant
reductions in haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) levels
when linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, is given as
add-on therapy in Type 2 diabetic patients inadequately controlled with
metformin. Furthermore, these phase II study results show a placebo-like
safety and tolerability profile under these therapeutic conditions. Notably,
in the study no case of hypoglycaemia was recorded with linagliptin
    "To date, metformin is the most widely used oral therapy in Type 2
diabetes. However, many patients do not achieve adequate glycaemic control
with metformin alone. As HbA1c and FPG levels are key diagnostic indicators
for effective management of Type 2 diabetes, the significant efficacy results
together with the favourable safety profile shown in this trial for the
investigational drug linagliptin are very encouraging. Based on the results
seen to date, we are very confident that linagliptin, if approved, can provide
additional benefit to patients with Type 2 diabetes," said Dr. Manfred Haehl,
MD, Senior Vice-President Medicine at Boehringer Ingelheim headquarters. "Type
2 diabetes is a progressive chronic condition which frequently requires
long-term treatment. Physicians treating patients with Type 2 diabetes need to
have a range of treatment options including combination regimens so they can
tailor the therapy to the individual patient's need and response. We are now
awaiting results from additional ongoing studies which will further assess the
full potential of linagliptin for the treatment of Type 2 diabetes."

    Trial objective and results:

    The aim of the 12-week, international, randomised, double-blind
placebo-controlled study was to assess the safety and efficacy profile of
linagliptin as add-on therapy in patients with Type 2 diabetes who were
failing to achieve glycaemic control despite being treated with metformin.
Primary endpoint was the change in HbA1c from baseline to week 12. Out of the
333 randomised patients, 268 patients received double-blind treatment with
linagliptin or placebo. Three doses of linagliptin were investigated in this
study: 1 mg, 5 mg and 10 mg. An open-label arm with 65 patients on glimepiride
was added for descriptive control.

    -   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.

    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

    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.


    (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

        (a)   Available at:
              Accessed on 28 April, 2009.

        (b)   Available at Accessed
              on 28 April, 2009.

    (3) 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

    (4) Woerle, H.J. et al. Diagnostic and Therapeutic Implications of
        Relationships Between Fasting, 2-Hour Postchallenge Plasma Glucose
        And Hemoglobin A1C Values. Arch Intern Med. 2004; 164:1627-1632.

    (5) American Diabetes Association. Diabetes Research. Available at:
        Accessed on: 22 April 2009

    For more information please visit

For further information:

For further information: Ursula Bardon, Corporate Division
Communications, Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Phone:
+49-6132-77-2622, Fax: +49-6132-72-2622, E-mail:

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