Diabetes: Boehringer Ingelheim and Eli Lilly and Company Alliance to have 43 Presentations Featured at the American Diabetes Association's 74th Scientific Sessions®

Diabetes: Boehringer Ingelheim and Eli Lilly and Company Alliance to have 43 Presentations Featured at the American Diabetes Association's 74th Scientific Sessions®

Data for LY2963016 (new insulin glargine product), empagliflozin, linagliptin and empagliflozin/linagliptin combination highlight robust alliance portfolio
IntroDia™: First global insights into primary care physician's challenges during the conversations at diagnosis of T2D

Ingelheim, Germany and Indianapolis, US, 10 June, 2014 – More than 40 presentations including posters, abstracts and oral presentations will demonstrate the breadth and depth of the Boehringer Ingelheim (BI) and Eli Lilly and Company (Lilly) diabetes portfolio at the American Diabetes Association's (ADA) 74th Scientific Sessions® in San Francisco, 13-17 June.


The range of presentations will include efficacy and safety data from three alliance compounds which are members of some of the largest diabetes treatment classes. In addition, the first physician insights from IntroDia™, a global survey being conducted in partnership with the International Diabetes Federation, will be unveiled during the congress.

Highlights include: LY2963016 (New Insulin Glargine Product):
LY2963016 (New Insulin Glargine Product): Efficacy and safety results for the investigational new insulin glargine product LY2963016 in comparison to Lantus® in adults with Type 1 (T1D) and Type 2 Diabetes (T2D).
Empagliflozin: ≥76 weeks safety and efficacy results for the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin as monotherapy, add-on to metformin, add-on to pioglitazone with or without metformin, add-on to metformin plus sulfonylurea in adults with T2D.
Linagliptin: Safety results for the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin in 8,778 adults with T2D from a pooled analysis of 23 placebo-controlled randomised clinical trials.
Empagliflozin/Linagliptin: 24 weeks efficacy and safety results from the investigational fixed dose combinations of empagliflozin/linagliptin in treatment naïve adults with T2D and as add-on to metformin in adults with T2D.
IntroDia™: Challenges faced by physicians during early treatment conversations in T2D management.
LY2963016, Investigational New Insulin Glargine Product Data

A total of six clinical abstracts for the investigational basal (long-acting) insulin LY2963016, new insulin glargine product, will be presented. LY2963016 is being developed for the treatment of patients with T1D and T2D.


Details of all clinical presentations and posters are as follows:

Saturday, 14 June 14, 08:00-10:00 PT, Oral Presentation – Basal Insulin Therapy
o    Similar Efficacy and Safety with LY2963016 Insulin Glargine Compared with Lantus® Insulin Glargine in Patients with T2D: the ELEMENT 2 Study (Presenting Author: J. Rosenstock) [Oral No. 64-OR]

o    Similar Efficacy and Safety with LY2963016 Insulin Glargine Compared with Lantus® Insulin Glargine in Patients with T1D: the ELEMENT 1 Study (Presenting Author: T. Blevins) [Oral No. 69-OR]

o    Evaluation of Immunogenicity of LY2963016 Insulin Glargine Compared with Lantus® Insulin Glargine in Patients with T1D or T2D (Presenting Author: M. Deeg) [Oral No. 70-OR]


Saturday, 14 June, 11:30-13:30 PT, General Poster Session
o    Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) of LY2963016 Insulin Glargine and EU- and US-approved Versions of Lantus® Insulin Glargine in Healthy Subjects (Presenting Author: H. Linnebjerg) [Poster No. 889-P]

o    Comparative Pharmacokinetics and Pharmacodynamics of Two Insulin Glargine Products, LY2963016 and Lantus®, in Healthy Subjects at Two Dose Levels (Presenting Author: X. Zhang) [Poster No. 890-P]

o    Duration of Action of 2 Insulin Glargine Products, LY2963016 and Lantus®, in Subjects with Type 1 Diabetes Mellitus (T1DM) (Presenting Author: T. Heise) [Poster No. 891-P]

 

Posters 889-P, 890-P and 891-P will also be featured in a guided audio poster tour on Monday, June 16, 13:00-13:50 PT, titled "Pharmacokinetic/Pharmacodynamic Insulin Studies."

Empagliflozin Data

A total of 17 clinical and non-clinical abstracts for empagliflozin will be presented, including three late-breaking abstracts. Empagliflozin, approved in Europe and Australia as Jardiance® is an oral, once daily tablet for the treatment of adults with T2D and is part of the SGLT2 inhibitor class. Inhibition of SGLT2 in adults with T2D and hyperglycaemia leads to excess glucose excretion in the urine.1

Details of clinical presentations and posters are as follows:

Saturday, 14 June, 09:45 PT, Symposium Presentation - Diabetes Care Symposium - New Drug Therapies, Innovative Management Strategies, and Novel Drug Targets
o    Improved Glucose Control with Weight Loss, Lower Insulin Doses and No Increased Hypoglycaemia with the SGLT2 Inhibitor Empagliflozin Added On to Titrated Multiple Daily Insulin Injections in Obese, Inadequately Controlled Patients with T2D (Presenting Author: J. Rosenstock) [No. CT-SY24]

Saturday, 14 June, 11:30-13:30 PT, General Poster Session
o    SGLT2 Inhibition Increases Urinary ACE2 Levels in Patients with T1D (Presenting Author: D. Cherney) [Poster No. 543-P]

o    SGLT2 Inhibition with Empagliflozin Reduces Microalbuminuria in Patients with T2D (Presenting Author: D. Cherney) [Poster No. 1125-P]

Sunday, 15 June, 12:00-14:00 PT, General Poster Session
o    Empagliflozin for ≥76 Weeks as Add-on to Pioglitazone With or Without Metformin in Patients with T2D (Presenting Author: C. Kovacs) [Poster No. 1055-P]

o    Empagliflozin for ≥76 Weeks as Add-on to Metformin in Patients with T2D (Presenting Authors: L. Merker) [Poster No. 1074-P]

o    Empagliflozin for ≥76 Weeks as Add-on to Metformin Plus Sulfonylurea in Patients with T2D (Presenting Author: H. Häring) [Poster No. 1077-P]

o    SGLT2 Inhibitor Empagliflozin in T1D: Impact on Diurnal Glycaemic Patterns (Presenting Author: B. Perkins) [Poster No. 1051-P]

o    Empagliflozin has no discernable effect on muscle sympathetic nerve activity in patients with T2D despite reductions in blood pressure and weight (Presenting Author: J. Jordan) [Poster No. 1030-P]

o    Efficacy and Safety of Empagliflozin in Younger, Overweight/Obese Patients with T2D with HbA1c ≥8% (Presenting Author: L. Merker) [Poster No. 1079-P]

o    Effect of empagliflozin monotherapy on postprandial glucose and 24-h glucose variability in Japanese patients with T2D (Presenting Author: R. Nishimura) [Poster No. 133-LB]

o    The Intraglomerular Hemodynamic Profile of Hyperfiltration Before and After SGLT2 Inhibition in Patients with T1D (Presenting Author: M. Skrtic) [Poster No. 22-LB]

o    Energy balance following SGLT2 inhibition (Presenting Author: G. Ferrannini) [Poster No. 125-LB]

Monday, 16 June, 08:00-10:00 PT, Oral Presentation – SGLT2 Inhibitors
o    Empagliflozin Compared with Glimepiride as Add-On to Metformin for 2 Years in Patients with T2D (Presenting Author: M. Ridderstråle) [Oral No. 266-OR]

o    Empagliflozin Monotherapy for ≥76 Weeks in Drug-Naïve Patients with T2D (Presenting Author: M. Roden] [Oral No. 264-OR]

Poster 1030-P will be featured in a guided audio tour on Saturday, 14 June, 11:30 - 12:20 PT titled "SGLT2 Inhibitors," and poster 1125-P will be featured in a guided audio poster tour on Sunday, 15 June, 13:00-13:50 PT titled "Treatment of Complications."

Linagliptin Data

A total of 16 clinical and non-clinical abstracts for linagliptin will be presented, including three late-breaker abstracts. Linagliptin, marketed as Trajenta® 5 mg tablets in Europe, is a once-daily tablet used along with diet and exercise to improve glycaemic control in adults with T2D, independent of their renal function. 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 clinical presentations and posters are as follows:

Sunday, 15 June, 08:15 PT, Oral Presentation – Oral Incretin-Based Therapies
o    Oral Glucose Lowering With Linagliptin Plus Metformin is a Viable Initial Treatment Strategy in Patients With Newly Diagnosed T2D and Marked Hyperglycaemia (Presenting Author: S. Ross) [Oral No. 150-OR]

Sunday, 15 June, 12:00-14:00 PT, General Poster Session
o    Efficacy and Safety of Linagliptin as Add-on to Basal Insulin in Patients with T2D and Renal Impairment (Presenting Author: J. McGill) [Poster No. 1026-P]

o    Long-term Efficacy and Safety of Linagliptin in T2D Patients with Moderate to Severe Renal Disease (Presenting Author: P-H. Groop) [Poster No. 1025-P]

o    Safety of Linagliptin in 8,778 Patients with T2D: Pooled Analysis of 23 Placebo-Controlled, Randomized Clinical Trials (Presenting Author: G. Schernthaner) [Poster No. 1081-P]

o    Efficacy and Cardiovascular Safety of Linagliptin as Add-on to Insulin in T2D – A Pooled Comprehensive Post-hoc Analysis (Presenting Author: B. Zinman) [Poster No. 1060-P]

o    Safety and tolerability of linagliptin and metformin in combination for patients with T2D (Presenting Author: S. Ross) [Poster No. 1071-P]

o    Risk of Hypoglycaemia in People Receiving Linagliptin: Pooled Data from 1,489 Adults Aged ≥65 years with T2D (Presenting Author: M. Nauck) [Poster No. 138-LB]

Posters 1025-P and 1026-P will also be featured in a guided audio poster tour on Saturday, 14 June, 12:30-13:20 PT, titled "Oral Agents/DPP-4 Inhibitors."

Investigational Empagliflozin/Linagliptin Combination Tablet

Two late-breaker abstracts for the investigational combination tablet of empagliflozin and linagliptin will be presented:
Details of clinical presentations and posters are as follows:
·       Sunday, 15 June, 12:00 – 14:00 PT, General Poster Session

o    Fixed dose combinations of empagliflozin/linagliptin for 24 weeks as add-on to metformin in patients with T2D (Presenting Author: R. DeFronzo) [Poster No. 130-LB]

o    Fixed dose combinations of empagliflozin/linagliptin for 24 weeks in drug-naïve patients with T2D (Presenting Author: A. Lewin) [Poster No. 129-LB]

IntroDia™

Two late-breaker abstracts will be presented for IntroDia™, a global survey being conducted in partnership with the International Diabetes Federation, evaluating early treatment conversations in T2D management.
·    Sunday, 15 June, 12:00 - 14:00 PT, General Poster Session

o    Physicians' Challenges When Discussing the T2D Diagnosis with Patients: Insights from a Cross-National Study (IntroDia™) (Presenting Author: A. Belton) [Poster No: 62-LB]

o    U.S. Physicians' Challenges When Presenting and Discussing the T2D Diagnosis with Patients: Insights from the Cross-National IntroDia™ Study (Presenting Author: WH. Polonsky) [Poster No: 60-LB]

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company entered into an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. 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, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2013, Boehringer Ingelheim achieved net sales of about €14.1 billion. R&D expenditure corresponds to 19.5% of its net sales.
For more information please visit www.boehringer-ingelheim.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 are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

 

This press release contains forward looking statements about the investigational fixed-dose combination of empagliflozin and linagliptin; empagliflozin, an investigational SGLT2 inhibitor being studied for the treatment of Type 2 Diabetes; LY2963016, an investigational long-acting insulin being studied for Type 1 and Type 2 Diabetes; linagliptin, a DPP-4 inhibitor approved for the treatment of Type 2 Diabetes along with diet and exercise; and linagliptin/metformin HCl, 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 commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date, or that the investigational fixed-dose combination of empagliflozin and linagliptin, empagliflozin or LY2963016 will be commercially successful, or that these compounds will receive regulatory approvals. 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.

###

CONTACT:

Ralph Warsinsky

Corporate Communications

Boehringer Ingelheim GmbH

Email: [email protected]

Phone: +49 178 290 8561

 

Tammy Hull

Communications Manager

Lilly Diabetes

Email: [email protected]

Phone: +1 317 651 9116

 

References
1.     Jardiance® (empagliflozin) tablets. EMA Summary of Product Characteristics. Approval 22 May 2014.

2.     Trajenta® (linagliptin) tablets, EMA Summary of Product Characteristics. April 2013. http://ec.europa.eu/health/documents/community-register/2013/20130422125838/anx_125838_en.pdf

 

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