Diabetes: Boehringer Ingelheim and Eli Lilly and Company announce data on portfolio to be presented at the 50th EASD Annual Meeting

Ingelheim, Germany and Indianapolis, US, 9 September, 2014 – Data to be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna, Austria, will add to the extensive clinical evidence supporting the efficacy and safety profile of the diabetes portfolio from the Boehringer Ingelheim (BI) and Eli Lilly and Company (Lilly) Diabetes Alliance. In addition, physician insights will be presented from IntroDia^™, the largest global survey of its kind in Type 2 Diabetes (T2D). The survey aims to investigate early conversations between physicians and people living with T2D.

Highlights of the presentations include:

• Empagliflozin, recently approved in Europe and in the US: Safety and tolerability of empagliflozin, a sodium cotransporter 2 (SGLT2) inhibitor, in Phase III trials and their extensions in adults with T2D
• Investigational empagliflozin/linagliptin combination tablet: 52 week efficacy and safety results from the investigational oral combinations of empagliflozin/linagliptin in treatment naïve adults with T2D and as add-on to metformin in adults with T2D
• Lilly/BI’s investigational insulin glargine product: Similar efficacy and safety with LY2963016 insulin glargine compared with insulin glargine in patients with Type 1 Diabetes (T1D): the ELEMENT 1 study
• Lilly/BI’s investigational insulin glargine product: Similar efficacy and safety with LY2963016 insulin glargine compared with insulin glargine in patients with T2D: the ELEMENT 2 study
• 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
• Linagliptin/metformin: Efficacy of linagliptin in combination with metformin in adults with newly diagnosed T2D and marked hyperglycaemia
• IntroDia^™: Challenges faced by physicians during the diagnosis conversations in T2D management.

Empagliflozin data
A total of 13 clinical and non-clinical abstracts for empagliflozin will be presented. Empagliflozin, approved as Jardiance^® in Europe and in the U.S., is an oral, once daily SGLT2 inhibitor for the treatment of adults with Type 2 Diabetes. SGLT2 inhibition reduces reabsorption of glucose into the bloodstream, allowing excess glucose to pass through the urine.¹

Details of the key clinical presentations and posters are as follows:

• Tuesday 16 September, 11:15–11:30, Oral Presentation: OP 01 SGLT2 inhibitors: new outcome studies
  • Empagliflozin compared with glimepiride as add-on to metformin for 2 years in patients with Type 2 Diabetes (Lead Author: M. Ridderstråle) [Abstract No. 2]
• Tuesday 16 September, 11:30–11:45, Oral Presentation: OP 01 SGLT2 inhibitors: new outcome studies 
  • Energy balance following sodium-glucose co-transporter-2 (SGLT2) inhibition (Lead Author: G. Ferrannini) [Abstract No. 3]
• Tuesday 16 September, 14:15, Poster Session: PS 062 SGLT2 inhibitors: non-glycaemic endpoints 
  • Effects of empagliflozin compared with glimepiride as add-on to metformin for 2 years on the amount and distribution of body fat in patients with type 2 diabetes (Lead Author: G. Kim) [Poster No. 818]
  • Sodium glucose cotransporter 2 inhibition with empagliflozin reduces microalbuminuria in patients (Lead Author: D. Cherney) [Poster No. 823]
• Wednesday 17 September, 14:15, Poster Session: PS 076 Glucose variability in insulin treatment 
  • Sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin (EMPA) in type 1 diabetes (T1D): impact on diurnal glycemic patterns (Lead Author: B.A. Perkins) [Poster No. 956]
• Thursday 18 September, 13:00, Poster Session: PS 065 SGLT2 inhibitors: efficacy
  • Empagliflozin twice daily versus once daily as add-on to metformin in patients with type 2 diabetes (Lead Author: S. Ross) [Poster No. 849]
• Thursday 18 September, 14:15, Poster Session: PS 060 SGLT2 inhibitors: safety 
  • Safety and tolerability of empagliflozin (EMPA) in Phase III trials and their extensions in patients with Type 2 Diabetes (T2DM) (Lead Author: M. Roden) [Poster No. 806]

Investigational empagliflozin/linagliptin combination tablet
Two clinical abstracts for the investigational empagliflozin/linagliptin combination tablet will be presented.

Details of the key clinical presentation and poster are as follows:

• Tuesday 16 September, 11:00–11:15, Oral Presentation: OP 01 SGLT2 inhibitors: new outcome studies 
  • Fixed dose combinations of empagliflozin/linagliptin for 52 weeks as add-on to metformin in patients with Type 2 Diabetes (Lead Author: S. Patel) [Abstract No. 1]
• Thursday 18 September, 13:00, Poster session: PS 065 SGLT2 inhibitors: efficacy 
  • Fixed dose combinations of empagliflozin and linagliptin for 52 weeks in drug-naïve patients with Type 2 Diabetes (Lead Author: A. Lewin) [Poster No. 851]

Lilly/Boehringer Ingelheim’s investigational insulin glargine data
A total of four clinical abstracts will be presented for Lilly/BI’s investigational insulin glargine product. This insulin glargine product is a basal insulin, which is intended to provide long-lasting blood sugar control between meals and at night in people with T1D and T2D.²

Details of the presentations and posters are as follows:

• Tuesday 16 September, 14:15, Poster Session: PS 074 The potential future of insulin therapy 
  • Comparison of duration of action of 2 insulin glargine products, LY2963016 and insulin glargine, in subjects with Type 1 Diabetes Mellitus (Lead Author: H. Linnebjerg) [Poster No. 935]
• Wednesday 17 September, 14:15, Poster Session: PS 076 Glucose variability in insulin treatment
  • Similar efficacy and safety with LY2963016 insulin glargine compared with insulin glargine in patients with Type 2 Diabetes Mellitus: the ELEMENT 2 study (Lead Author: P. Hollander) [Poster No. 948]
• Thursday 18 September, 10:30–10:45, Oral Presentation: OP 25 Novel insulin formulations and combinations 
  • Similar efficacy and safety with LY2963016 insulin glargine compared with insulin glargine in patients with Type 1 Diabetes Mellitus: the ELEMENT 1 study (Lead Author: R.K. Pollom) [Abstract No.146]
• Thursday 18 September, 14:15, Poster Session: PS 078 Insulin immunogenicity and kinetics 
  • Evaluation of immunogenicity of LY2963016 insulin glargine compared with insulin glargine in patients with Type 2 Diabetes Mellitus (Lead Author: L. Ilag) [Poster No. 969]

Linagliptin data
A total of seven clinical and non-clinical abstracts for linagliptin will be presented. Linagliptin, marketed as Trajenta^® in Europe, is a once-daily tablet used to improve blood glucose control in adults with T2D. Linagliptin is an inhibitor of the enzyme DPP-4 which breaks down the incretin hormones that are involved with regulating blood glucose.³

Details of the key clinical posters are as follows:

• Tuesday 16 September, 13:00, Poster Session: PS 061 Insulin secretagogues
  • Efficacy and safety of initial therapy with linagliptin + pioglitazone fixed-dose combinations versus monotherapy with pioglitazone or linagliptin (Lead author: S. Weber-Born) [Poster No. 815]
• Wednesday 17 September, 13:00, Poster Session: PS 069 Safety of DPP4 inhibitors 
  • Safety of linagliptin in 8778 patients with Type 2 Diabetes Mellitus: pooled analysis of 23 placebo-controlled randomised clinical trials (Lead Author: G. Schernthaner) [Poster No. 885]

Linagliptin and metformin data
One clinical abstract for linagliptin in combination with metformin will be presented.

Details of the clinical poster are as follows:

• Wednesday 17 September, 14:15, Poster session: PS 070 Clinical studies with DPP-4 inhibitors
  • Oral glucose lowering with linagliptin plus metformin is a viable initial treatment strategy in patients with newly diagnosed type 2 diabetes and marked hyperglycaemia (Lead Author: B. Gallwitz) [Poster No. 894]

IntroDia^™
One abstract will be presented for IntroDia^™, the largest global survey being conducted in partnership with the International Diabetes Federation. The survey is evaluating early treatment conversations in T2D management.

Details of the poster are as follows:

• Tuesday 16 September, 14:15, Poster Session: PS 086 Psychology and quality of life 
  • Physicians’ challenges when discussing the T2D diagnosis with patients: insights from a cross-national study (IntroDia^™) (Lead Author: W.H. Polonsky) [Poster No. 1030]

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 oral combinations of empagliflozin and linagliptin; empagliflozin, an SGLT2 inhibitor approved for the treatment of Type 2 Diabetes along with diet and exercise; Lilly/Boehringer Ingelheim’s investigational insulin glargine product; 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 oral combinations of empagliflozin and linagliptin, 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.