Boehringer Ingelheim and Eli Lilly and Company present efficacy and safety data on linagliptin and investigational compound

  Boehringer Ingelheim and Eli Lilly and Company present efficacy and safety
  data on linagliptin and investigational compound empagliflozin* in various
  diabetes subpopulations

Boehringer Ingelheim and Eli Lilly and Company to feature 17 presentations
during the 49th Annual Meeting of the European Association for the Study of
Diabetes (EASD)

Business Wire

INGELHEIM, Germany & INDIANAPOLIS, Ind. -- September 17, 2013

Ex - US & Ex - UK Medical Media Only

Boehringer Ingelheim and Eli Lilly and Company today announced they will
feature five oral and 12 poster presentations for linagliptin and the
investigational compound  empagliflozin* at the 49^th Annual Meeting of the
European Association for the Study of Diabetes (EASD) which will take place in
Barcelona, from 23 – 27 September. The presentations will add to the already
existing body of data on safety and efficacy of these two compounds.

Empagliflozin Data
A total of eight clinical and pre-clinical abstracts for the investigational
agent empagliflozin will be presented. Empagliflozin is a member of the sodium
glucose cotransporter 2 (SGLT2) inhibitor class of drugs and is being
investigated for the reduction of blood glucose levels in adults with Type 2
Diabetes (T2D).

Details of clinical empagliflozin presentations and published abstracts are as
follows:^1

Tuesday, 24 ^  September, 12:30–13:30 CET, General Poster Session

  *Empagliflozin as Add-on to Basal Insulin for 78 Weeks Improves Glycemic
    Control and Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM)
    (Presenting Author: J. Rosenstock) [Poster No. 931]
  *Safety and Efficacy of Empagliflozin Monotherapy in a 52-Week Study in
    Japanese Patients with Type 2 Diabetes Mellitus (Presenting Author: H. J.
    Woerle) [Poster No. 930]
  *Metabolic Response to Sodium Glucose Transporter 2 (SGLT2) Inhibition with
    Empagliflozin in Patients with Type 2 Diabetes (T2D) (Presenting Author:
    E. Ferrannini) [Poster No. 932]

Tuesday, 24 September, 13:45–14:45 CET, General Poster Session

  *Empagliflozin Improves Blood Pressure in Patients with Type 2 Diabetes
    (T2DM) and Hypertension (Presenting Author: I. Tikkanen) [Poster No. 942]
  *Empagliflozin Improved Glycemic Parameters and Cardiovascular Risk Factors
    in Patients with Type 2 Diabetes (T2DM): Pooled Data from Four Pivotal
    Phase III Trials (Presenting Author: T. Hach) [Poster No. 943]
  *Design of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2
    Diabetes Mellitus (Presenting Author: S. E. Inzucchi) [Poster No. 944]

Wednesday, 25 September, 12:30–13:30 CET, General Poster Session

  *Empagliflozin in Patients with Type 2 Diabetes Mellitus (T2DM) and Stage
    3A, 3B and 4 Chronic Kidney Disease (CKD) (Presenting Author: A. Mithal)
    [Poster No. 952]

Thursday, 26 September, 15:00 – 16:30 CET, Oral Presentation

  *The Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitor Empagliflozin
    Improves Glycemic Control in Patients with Type 1 Diabetes: a Single-Arm
    Clinical Trial (Presenting Author: B. A. Perkins) [Oral Presentation No.
    183]

* Empagliflozin is an investigational compound. Its safety and efficacy have
not been established.

Linagliptin Data
A total of nine clinical and pre-clinical abstracts for linagliptin will also
be presented. Linagliptin is an inhibitor of the enzyme dipeptidyl peptidase-4
(DPP-4), which breaks down the incretin hormones glucagon-like peptide-1
(GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) that are
involved with regulating blood glucose.^2

Details of all clinical presentations and published abstracts are as
follows:^1

Wednesday, 25 September, 10:45 – 12:15 CET, Oral Presentation

  *Baseline Characteristics of Participants Enrolled in the Cardiovascular
    Outcome Study of Linagliptin versus Glimepiride in Early Type 2 Diabetes
    (CAROLINA) (Presenting Author: J. Rosenstock) [Oral Presentation No. 73]

Wednesday, 25 September, 12:30 – 13:30 CET, General Poster Session

  *Efficacy and Safety of Linagliptin as Add-On Therapy to Basal Insulin and
    Metformin in Patients with Type 2 Diabetes (Presenting Author: S.
    Durán-Garcia) [Poster No. 892]

Wednesday, 25 September, 15:00 – 16:30 CET, Oral Presentation

  *Cardiovascular (CV) Safety of Linagliptin in Patients with Type 2 Diabetes
    (T2D): A Pooled Comprehensive Analysis of Prospectively Adjudicated CV
    Events in Phase 3 Studies (Presenting Author: O. E. Johansen) [Oral
    Presentation No. 112]
  *Linagliptin and the Angiotensin II Receptor Blocker Telmisartan Show
    Comparable Efficacy but Different Renoprotective Pathways in Rats with 5/6
    Nephrectomy (Presenting Author: B. Hocher) [Oral Presentation No. 143]

Thursday, 26 September, 10:45 – 12:15 CET, Oral Presentation

  *Insights into the Mechanism of Action of Linagliptin in Reducing Ischaemic
    Brain Damage Following Stroke in Diabetic and Non-Diabetic Mice
    (Presenting Author: V. Darsalia) [Oral Presentation No. 152]

Thursday, 26 September, 12:30 – 13:30 CET, General Poster Session

  *Renal Safety and Outcomes with Linagliptin: Meta-Analysis of Individual
    Data for 5466 Patients with Type 2 Diabetes (Presenting Author: M. von
    Eynatten) [Poster No. 913]
  *Linagliptin versus Placebo followed by Glimepiride in Type 2 Diabetes
    Patients with Moderate to Severe Renal Impairment (Presenting Author: P-H.
    Groop) [Poster No. 914]

Thursday, 26 September, 13:45 – 14:45 CET, General Poster Session

  *Safety and Tolerability of Linagliptin in 7400 Patients with Type 2
    Diabetes: A Pooled Comprehensive Analysis of Prospective Safety Reporting
    in Placebo-Controlled Studies (Presenting Author: M. Lehrke) [Poster No.
    986]
  *Renal Safety of Linagliptin in Elderly Patients with Type 2 Diabetes:
    Analysis of Pooled Patient Data From 7 Phase 3 Clinical Trials (Presenting
    Author: A. H. Barnett) [Poster No. 926]

Linagliptin, which is marketed as Trajenta^® 5mg tablets in Europe, is a
once-daily tablet used along with diet and exercise to improve glycaemic
control in adults with Type 2 Diabetes. Linagliptin should not be used in
patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis
(increased ketones in the blood or urine). Linagliptin is the only approved
DPP-4 inhibitor that does not require dose adjustments regardless of renal or
hepatic function.

                                    ~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/17_september_2013diabetes.html

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Contact:

Dr. Ralph Warsinsky
Corporate Communications
Boehringer Ingelheim GmbH
Email: press@boehringer-ingelheim.com
Phone: +49 178 290 8561
or
Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: +1 317 651 9116
 
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