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)

Ex -US & Ex- UK Medical Media Only

Ingelheim, Germany and Indianapolis, US, 17 September, 2013 – 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 49th 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:

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]

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.

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

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.

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

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.

This press release contains forward looking statements about empagliflozin, an investigational compound that is being studied for 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, or that empagliflozin will receive regulatory approvals or prove to 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.

Referências

References
1EASD 2013 online programme, Accessed: http://www.easdvirtualmeeting.org/events/2/program/days/2013-09-24
2EMA Trajenta (linagliptin) tablets. EMA Summary of Product Characteristics. 2013
3International Diabetes Federation. The Global Burdeb IDF Diabetes Atlas 2012, 5th Edition:
4World Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited January 2013]; Available from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html
5International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. (2012, 5th Edition)

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