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Boehringer Ingelheim and Lilly to Feature Type 2 Diabetes Research in More Than 25 Presentations at the 71st American Diabetes Association Scientific Sessions

June 20, 2011

RIDGEFIELD, Conn. and INDIANAPOLIS, June 20, 2011 /PRNewswire/ — Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) will present the latest data from their diabetes portfolio at the 71st American Diabetes Association (ADA) Scientific Sessions in San Diego on June 24-28. Study results evaluating the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, as well as the investigational sodium glucose cotransporter-2 (SGLT-2) inhibitor BI-10773, will be featured among the 27 presentations. Linagliptin, 5 mg, is marketed under the trade name Tradjenta(TM) (linagliptin) tablets in the U.S. and was approved by the U.S. Food and Drug Administration (FDA) in May 2011 to be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.

To view the multimedia assets associated with this release, please click: http://multivu.prnewswire.com/mnr/boehringer-ingelheim/50750/

Two linagliptin abstracts were selected by ADA as President’s Posters, a prestigious session showcasing 100 specially-selected posters on Sunday, June 26 and repeated on Monday, June 27. Two additional Phase III studies evaluating cardiovascular events will be highlighted as late-breaking posters.

Among the presentations are the following:

Linagliptin Data


                                                          Presentation
    Title           Format         Authors                details
    -----           ------         -------                ------------
                                    L Sloan, J Newman,
                                    C Sauce, M von
    Phase III        President's    Eynatten, S Patel,    President's Poster
     (12-week)       Poster         H-J Woerle            Reception
    ---------        ------------  -------------------   -------------------
    Safety and
     Efficacy of
     Linagliptin
     in Type 2
     Diabetes
     Patients
     with Severe
     Renal
     Impairment     413-PP          Date: Sun, June 26
    ------------    ------                               ------------------
                                                         Time: 6:45-8 p.m.
                                                         -----------------
                                                          President's Poster
                                                          Session
                                                         -------------------
                                                         Date: Mon, June 27
                                                         ------------------
                                                         Time: 12-2 p.m.
                                                         ---------------
                                    M Cooper, M von
    Phase III                       Eynatten, A Emser,
     (pooled                        S Patel, H-J
     analysis)      Poster          Woerle               Date: Sat, June 25
    ---------       ------         -------------------   ------------------
    Efficacy and
     Safety of
     Linagliptin
     in Patients
     with Type 2
     Diabetes
     with or
     without
     Renal
     Impairment:
     Results
     From a
     Global
     Phase III                       Time: 11:30
     Program        1068-P           a.m.-1:30 p.m.
    ------------    ------                               ---------------
                                    T Haak, T Meinicke,
                                    R Jones, M von
    Phase III                       Eynatten, H-J
     (24-week)      Oral            Woerle               Date: Mon, June 27
    ---------       ----            -------------------- ------------------
    Combination
     of
     Linagliptin
     and
     Metformin
     Improves
     Glycemic
     Control in
     Type 2
     Diabetes: A
     Randomized
     Trial with
     an Open-
     Label Arm
     in Patients
     with Poor
     Glycemic
     Control        279-OR          Time: 8-10 a.m.
    ------------    ------                               ---------------

                                    B Gallwitz, B
                     Late-          Uhlig-Laske, S
    Phase III        Breaking       Battacharaya, S
     (2-year)         Poster        Patel, H-J Woerle    Date: Sun, June 26
    ---------        ---------     ------------------    ------------------
    Linagliptin
     has
     Improved
     Safety and
     Similar
     Efficacy to
     Glimepiride
     over 2
     Years in
     Patients
     with Type 2
     Diabetes
     Mellitus
     Inadequately
     Controlled
     on
     Metformin      39-LB           Time: 12-2 p.m.
    -------------   -----                                ---------------
                                    O-E Johansen, D
    Phase III        Late-          Neubacher, M von
     (meta-          Breaking       Eynatten, S Patel,
     analysis)       Poster         H-J Woerle           Date: Sun, June 26
    ---------        --------       ------------------   ------------------
     Cardiovascular
     Risk with
     Linagliptin
     in Patients
     with Type 2
     Diabetes: A
     Pre-
     specified,
     Prospective,
     and
     Adjudicated
     Meta-
     Analysis
     from a
     Large Phase
     III Program    30-LB           Time: 12-2 p.m.
     -------------- -----                                ---------------

                      S Del Prato, M-R
                      Taskinen, D Owens,
    Phase III         M von Eynatten, A
     (pooled          Emser, S Patel, H-
     analysis)      Poster          J Woerle             Date: Sat, June 25
    ---------       ------         -------------------   ------------------
    Efficacy and
     Safety of
     Linagliptin
     in Patients
     with Type 2
     Diabetes
     and Poor
     Glycemic                        Time: 11:30
     Control        1067-P           a.m.-1:30 p.m.
    ------------    ------                               ---------------
    Phase III                       C Friedrich, A
     (pooled                        Emser, H-J
     analysis)      Poster          Woerle,              Date: Sat, June 25
    ---------       ------         ---------------       ------------------
    Renal
     Impairment
     has no
     Relevant
     Effect on
     Long-Term
     Exposure of
     Linagliptin
     in Patients
     with Type 2                                          Time: 11:30
     Diabetes       1105-P         U Graefe-Mody          a.m.-1:30 p.m.
    -----------     ------         -------------         ---------------
                      J Rosenstock, N
                      Marx, SE Kahn, B
                      Zinman, J
                      Kastelein, J
                      Lachin, E Bluhmki,
                      A Schlosser, D
                      Neubacher, S
                      Patel, O-E
                      Johansen, H-J
    Phase III       Poster          Woerle               Date: Sat, June 25
    ---------       ------         -------------------   ------------------
    The
     Rationale
     and Design
     of the
     CAROLINA
     trial: An
     Active
     Comparator
     CARdiOvascular
     Outcome
     Study of
     the DPP-4
     Inhibitor
     Linagliptin
     in Patients
     with Type 2
     Diabetes at
     High
     Cardiovascular                  Time: 11:30
     Risk           1103-P           a.m.-1:30 p.m.
    --------------- ------                               ---------------
                                    P-H Groop, M von
    Phase III                       Eynatten,  A
     (pooled         Publication    Emser, S Patel, H-
     analysis)       only           J Woerle                             N/A
    ---------        -----------    ------------------                   ---
    Efficacy and
     Safety of
     Linagliptin
     in Type 2
     Diabetes
     Patients at
     High Risk
     of Renal
     Complications:
     Results
     From a
     Large Phase
     III Program    2274-PO
    --------------- -------
    Phase III                       G Schernthaner, M
     (pooled         Publication    von Eynatten, A
     analysis)        only          Emser, H-J Woerle                    N/A
    ---------        ------------  ------------------                    ---
    Safety and
     Tolerability
     of
     Linagliptin:
     A Pooled
     Analysis of
     Data from
     3572
     Patients
     with Type 2
     Diabetes       2327-PO
    -------------   -------
                                    A-H Barnett, AA
                                    Tahrani, M von
    Phase III                       Eynatten, A Emser,
     (pooled         Publication    S Patel, H-J
     analysis)       only           Woerle                               N/A
    ---------        -----------    ------------------                   ---
    The Novel
     DPP-4
     Inhibitor
     Linagliptin
     is
     Associated
     with a Very
     Low Risk of
     Hypoglycemia:
     Results
     from a
     Large Phase
     III Program    2346-PO
    --------------  -------
                                    T Klein, R
                                    Grempler, E
                                    Mayoux, H Niessen,
                     President's    S Cheetham, D         President's Poster
    Preclinical      Poster         Stiller, M Mark       Reception
    -----------      -----------    ------------------    ------------------
    The DPP-4
     Inhibitor
     Linagliptin
     Reduces
     Intra-
     myocellular
     and Hepatic
     Lipid
     Accumulation
     in a Diet-
     induced
     Obesity Rat
     Model: An
     MRS-based
     Study in
     Comparison
     to
     Sibutramine    415-PP          Date: Sun, June 26
    -------------   ------                               ------------------
                                                         Time: 6:45-8 p.m.
                                                         -----------------
                                                          President's Poster
                                                          Session
                                                         -------------------
                                                         Date: Mon, June 27
                                                         ------------------
                                                         Time: 12-2 p.m.
                                                         ---------------

BI-10773 Data


                                                     Presentation
    Title               Format       Authors         details
    -----               ------       -------         ------------
                                      J
                                      Rosenstock,
                                      A
                                      Jelaska,
                                      L Seman,
                                      S
                                      Pinnetti,
                                      S Hantel,      General
                        Moderated     H-J            poster
    Phase II            poster        Woerle         session
    --------            ----------    ------------  --------
    Efficacy and
     Safety of BI-
     10773, a New
     Sodium Glucose
     Cotransporter-
     2 (SGLT-2)
     Inhibitor, in
     Type 2 Diabetes
     Inadequately
     Controlled on                     Date: Sat,
     Metformin          989-P           June 25
    ----------------    -----                        ----------
                                                     Time:
                                                      11:30
                                                      a.m.-1:30
                                                      p.m.
                                                     ----------
                                                     Guided
                                                     audio
                                                     poster
                                                     tour
                                                    -------
                                                     Date: Sun,
                                                      June 26
                                                     ----------
                                                     Time: 12-1
                                                      p.m.
                                                     ----------
                         M Riggs, S
                         Macha, L
                         Seman, A
                         Staab, T
                         MacGregor,
                         H-J
                         Woerle, W
                         Gillispie,
                         M              Date: Sat,
    Phase I/II          Poster        Gastonguay     June 25
    ----------          ------        ----------     ----------
    Evaluation of
     Efficacy and
     Tolerability
     Using Exposure-
     Response
     Modeling for
     BI-10773, a
     Sodium Glucose
     Cotransporter-
     2 (SGLT-2)                        Time:
     Inhibitor, in                     11:30
     Patients with                     a.m.-1:30
     Type 2 Diabetes    1069-P         p.m.
    ----------------    ------                      ----------
                                      C
                                      Friedrich,
                                      K
                                      Metzmann,
                                      P Rose, M
                                      Mattheus,
                                      S
                                      Pinnetti,
                        Publication   H-J
    Phase I             only          Woerle                  N/A
    -------             -----------   ----------              ---
    Pharmacokinetics
     and
     Pharmacodynamics
     of BI-10773, a
     Sodium Glucose
     Cotransporter-2
     (SGLT-2)
     Inhibitor, and
     Linagliptin, a
     Dipeptidyl
     Peptidase-4
     (DPP-4)
     Inhibitor,
     Following Co-
     Administration
     in Healthy
     Volunteers         2318-PO
    ----------------    -------

Health Economics and Outcomes Research Data (HEOR)


                                                       Presentation
    Title           Format        Authors              details
    -----           ------        -------              ------------
                     Late-         S-Y Chen, B
                     Breaking      Kovacs, M Stokes,
                     Poster        S Sander, K Siu, P
    US - HEOR        52-LB         Rao, L Boulanger   Date: Sun, June 26
    ---------        ---------    ------------------  ------------------
    Clinical and
     Economic
     Outcomes of
     Appropriate
     Oral
     Antidiabetic
     Drug (OAD)
     Treatment
     Among Type 2
     Diabetes
     Mellitus
     (T2DM)
     Patients with
     Chronic Kidney
     Disease (CKD)    Time: 12-2 p.m.
    ---------------                                   ---------------
                                   J Burke, K Siu, B
                     Publication   Kovacs, L Borton,
    US - HEOR        only          S Sander                           N/A
    ---------        -----------  ------------------                  ---
    Insulin Use,
     its Associated
     Costs,
     Glycemic
     Control and
     Hypoglycemia
     in Patients
     with Type 2
     Diabetes
     Mellitus and
     Renal
     Impairment     2107-PO
    --------------- -------

To learn more about TRADJENTA and for full prescribing information visit: www.TRADJENTA.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication and Important Limitations of Use

TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

TRADJENTA has not been studied in combination with insulin.

Important Safety Information

CONTRAINDICATIONS

TRADJENTA is contraindicated in patients with a history of hypersensitivity reaction to linagliptin, such as urticaria, angioedema or bronchial hyperreactivity.

WARNINGS AND PRECAUTIONS

Use with Medications Known to Cause Hypoglycemia

Insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with TRADJENTA.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRADJENTA or any other antidiabetic drug.

ADVERSE REACTIONS

Adverse reactions reported in >/= 5% of patients treated with TRADJENTA and more commonly than in patients treated with placebo included nasopharyngitis.

Hypoglycemia was more commonly reported in patients treated with the combination of TRADJENTA and sulfonylurea compared with those treated with the combination of placebo and sulfonylurea. Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person-years versus zero in 433 person-years for comparator).

DRUG INTERACTIONS

The efficacy of TRADJENTA may be reduced when administered in combination with a strong P-glycoprotein or CYP3A4 inducer (e.g., rifampin). Therefore, use of alternative treatments is strongly recommended.

USE IN SPECIFIC POPULATIONS

There are no adequate and well-controlled studies in pregnant women. Therefore, TRADJENTA should be used during pregnancy only if clearly needed. It is not known whether linagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRADJENTA is administered to a nursing woman. Safety and effectiveness of TRADJENTA in patients below the age of 18 have not been established.

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on four pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies’ strengths as two of the world’s leading pharmaceutical companies, combining Boehringer Ingelheim’s solid track record of research-driven innovation and Lilly’s innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion (about 12.6 billion euro) while spending almost 24 percent of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes

For more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. Lilly introduced the world’s first commercial insulin in 1923, and remains at the forefront of medical and delivery device innovation to manage diabetes. Lilly is also committed to providing solutions beyond therapy – practical tools, education, and support programs to help overcome barriers to success along the diabetes journey. At Lilly, the journeys of each person living with or treating diabetes inspire ours. For more information, visit www.lillydiabetes.com.

This press release contains forward-looking statements about TRADJENTA or the treatment of type 2 diabetes. It reflects Lilly’s current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that TRADJENTA will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly’s latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

P-LLY

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company


Source: newswire



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