New Data From Boehringer Ingelheim's Ongoing Linagliptin Trial Programme Show Promising Safety And E

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New Data From Boehringer Ingelheim's Ongoing Linagliptin Trial Programme Show Promising

Safety and Efficacy Results


INGELHEIM, June 7 /PRNewswire-AsiaNet/ --


    - Results From Linagliptin Study in Type 2 Diabetes Patients Who Were

Inadequately Controlled on Metformin Therapy Alone, Presented at Major

Diabetes Meeting


    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 treatment.(1)


    "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.


    

    References


    (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



           on 28 April, 2009. 

       (b) Available at http://www.eatlas.idf.org/index3669.html. 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

Community Health Boehringer Ingelheim 2 image

        And Hemoglobin A1C Values. Arch Intern Med. 2004; 164:1627-1632.


    (5) American Diabetes Association. Diabetes Research. Available at:


April 2009



    For more information please visit http://www.boehringer-ingelheim.com


    SOURCE: Boehringer Ingelheim

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