Value through Innovation01 October 2014
11 June 2013

Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 34 Presentations in Type 1 and Type 2 Diabetes at the 73rd American Diabetes Association® Scientific Sessions

Ingelheim, Germany and Indianapolis, US, 11 June, 2013 – Boehringer Ingelheim and Eli Lilly and Company are pleased to announce that the companies’ diabetes alliance will have a strong scientific and clinical presence at the 73rd American Diabetes Association® (ADA) Scientific Sessions in Chicago, 21–25 June, with 34 posters, abstracts and an oral presentation.

Empagliflozin* Data
A total of 17 clinical and pre-clinical abstracts for the investigational agent empagliflozin will be presented, including three late-breaker abstracts. 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). The emerging SGLT2 inhibitor class removes excess glucose through the urine by reducing glucose reabsorption in the kidney.

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

  • Saturday, 22 June, 11:30–13:30, General Poster Session
    • Sodium Glucose Cotransport-2 Inhibition with Empagliflozin Attenuates Renal Hyperfiltration in Patients with Type 1 Diabetes (T2DM) (Presenting Author: D. Cherney) [Poster No. 1196-P]
  • Sunday, 23 June, 12:00-14:00, General Poster Session
    • Empagliflozin Improves 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) [Late-breaking poster - Poster No. 69-LB]
    • Metabolic Response to Sodium-Glucose Transporter 2 (SGLT2) Inhibition with Empagliflozin in Patients with Type 2 Diabetes (T2D) (Presenting Author: E. Ferrannini) [Late-breaking poster - Poster No.71-LB] 
    • Empagliflozin (EMPA) Increases Genital Infections but Not Urinary Tract Infections (UTIs) in Pooled Data from Four Pivotal Phase III Trials (Presenting Author: G. Kim [Late-breaking poster - Poster No. 74-LB]
    • The Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitor Empagliflozin Improves Glycaemic Control in Patients with Type 1 Diabetes: A Single-Arm Clinical Trial (Presenting Author: B. Perkins) [Poster No. 1074-P]
    • Empagliflozin as Add-On to Metformin Plus Sulfonylurea (SU) for 24 weeks Improves Glycaemic Control in Patients with Type 2 Diabetes (T2DM) (Presenting Author: H. Häring) [Poster No. 1082-P]
    • Empagliflozin Monotherapy Improves Glucose Control in Drug-Naïve Patients with Type 2 Diabetes (T2DM) (Presenting Author: M. Roden) [Poster No. 1085-P]
    • Empagliflozin as Add-On to Metformin for 24 weeks Improves Glycaemic Control in patients with Type 2 Diabetes (T2DM) (Presenting Author: L. Merker) [Poster No. 1092-P]
    • Empagliflozin as Add-On to Basal Insulin for 78 weeks Improves Glycaemic Control with Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM) (Presenting Author: J. Rosenstock) [Poster No. 1102-P]
    • Empagliflozin in Patients with Type 2 Diabetes Mellitus (T2DM) and Renal Impairment (RI) (Presenting Author: H. Rattunde) [Poster No. 1104-P]
    • Empagliflozin as Add-On to Pioglitazone With or Without Metformin Improves Glycaemic Control in Patients with Type 2 Diabetes (T2DM) (Presenting Author: C. Kovacs) [Poster No. 1120-P]
    • Empagliflozin Monotherapy for 12 weeks Improves Glycaemic Control in Japanese Patients with Type 2 Diabetes (T2DM) (Presenting Author: M. Haneda) [Poster No. 1144-P]
  • Publication Only
    • Design of the Empagliflozin Cardiovascular (CV) Outcome Event Trial in Type 2 Diabetes (T2D) (Author: B. Zinman) [Abstract No. 2349-PO]

Linagliptin Data
A total of 17 clinical and pre-clinical abstracts regarding linagliptin will also be presented, including two late-breaker abstracts. Linagliptin is an inhibitor of the enzyme 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 sugar.2

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

  • Tuesday, 25 June, 8.00–10.00, Oral Presentation – New Information on DPP-4 Inhibition
    • CV safety of linagliptin in patients with Type 2 Diabetes: a pooled comprehensive analysis of prospectively adjudicated CV events in Phase III studies (Presenting Author: O.E. Johansen) [Oral No: 376-OR] (Pooled data)
  • Sunday, 23 June, 12.00–14.00, General Poster Session
    • Lower risk of hypoglycemia in elderly type 2 diabetes patients when linagliptin is added to basal insulin: an exploratory analysis (Presenting Author: M. Von Eynatten [Late-breaking poster – Poster No. 2-LB]
    • Regardless of the degree of glycemic control, linagliptin (LINA) has Lower hypoglycemia risk than all doses of glimepiride (GLIM) at all time points over a 2-year trial (Presenting Author: B. Gallwitz) [Late-breaking poster – Poster No. 68-LB]
    • Linagliptin vs. placebo followed by glimepiride in type 2 diabetes patients with moderate to severe renal impairment (Presenting Author: S. Patel) [Poster No. 1090-P]
    • Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone (Presenting Author: M. Bajaj) [Poster No. 1093-P]
    • The dipeptidyl peptidase (DPP)-4 inhibitor linagliptin improves beta cell function and postprandial glucose in patients with type 2 diabetes (Presenting Author: M. Larbig) [Poster No. 1138-P]
    • Efficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus: a 24-week, randomised, Phase III clinical trial (Presenting Author: Y. Chen) [Poster No. 1159-P]
    • Efficacy and safety of linagliptin in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin: a 24-week, randomised, Phase III clinical trial (Presenting Author: W. Wang) [Poster No. 1177-P]
  • Publication Only
    • Baseline characteristics of patients enrolled in the cardiovascular outcome study of linagliptin versus glimepiride in patients with Type 2 Diabetes (CAROLINA) (Published Author: N. Marx) [Abstract book for the American Diabetes Association (ADA) 73rd Scientific Sessions]

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 a DPP-4 inhibitor that does not require dose adjustments that may be brought about by declining renal function or hepatic impairment.

About Diabetes
An estimated 371 million people worldwide have Type 1 or Type 2 Diabetes.3 Type 2 Diabetes is the most common type, accounting for an estimated 90–95% of all diabetes cases.2 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.4

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 centres on three compounds representing several of the largest diabetes 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
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 endeavours.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

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 organisations. 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
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions – from medicines to support programmes and more – to make lives better.

For more information, visit www.lillydiabetes.com.

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

This press release contains forward looking statements about empagliflozin, an investigational compound for the treatment of Type 2 Diabetes and linagliptin, a DPP-4 inhibitor approved for the treatment of Type 2 Diabetes along with diet and exercise. 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 commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date that linagliptin 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.

References
1Abstract book for the American Diabetes Association (ADA) 73rd Scientific Sessions
2Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011.
3International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.
4International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 4, 2013

Media contact

  • Media Contact Dr Ralph Warsinsky
    Boehringer Ingelheim

    Media & PR
    Dr Ralph Warsinsky
    Binger Strasse 173
    55216 Ingelheim am Rhein
    GERMANY

Media contact

  • Eli Lilly and Company

    Communications Manager
    Lilly Diabetes
    Tammy Hull

    • Phone +1 (317) 651-9116

Media contact

  • Media Contact Dr Ralph Warsinsky
    Boehringer Ingelheim

    Media & PR
    Dr Ralph Warsinsky
    Binger Strasse 173
    55216 Ingelheim am Rhein
    GERMANY

Media contact

  • Eli Lilly and Company

    Communications Manager
    Lilly Diabetes
    Tammy Hull

    • Phone +1 (317) 651-9116