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90-week data suggest sustained glucose reduction and weight loss with 
investigational SGLT-2 inhibitor, empagliflozin 
 
Study evaluating the efficacy and safety of empagliflozin up to 90 weeks 
presented during a late-breaking session at the American Diabetes Association's 
72nd Scientific Sessions® 
 
Ridgefield, CT and Indianapolis, IN, June 9, 2012 - Boehringer Ingelheim 
Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) presented results 
that showed empagliflozin (BI 10773), alone or as an add-on to metformin, 
reduced hemoglobin A1c (HbA1c or A1C) levels, fasting plasma glucose (FPG) 
levels and body weight when given to adults with type 2 diabetes for up to 90 
weeks. A1C is measured in people with diabetes to provide an index of blood 
glucose control for the previous two to three months. The new data, from a 
phase 2b open-label extension study, were presented during a late-breaking 
session at the American Diabetes Association's (ADA's) 72nd Scientific Sessions 
®. 
 
Empagliflozin inhibits SGLT-2, which blocks glucose reuptake in the kidney, 
thereby removing excess glucose through the urine. 
 
"These new findings provide additional information about the use of 
empagliflozin in type 2 diabetes, and support the phase 3 trials that are 
underway to confirm the drug's efficacy and safety profile," said John Smith, 
M.D., Ph.D., senior vice president for clinical development and medical 
affairs, Boehringer Ingelheim Pharmaceuticals, Inc. 
 
In the open-label study, adults with type 2 diabetes (n=659) who participated 
in one of two 12-week, blinded, dose-finding empagliflozin trials, were treated 
for an additional 78 weeks with open-label empagliflozin 10 mg or 25 mg 
(monotherapy or add-on to metformin), metformin alone, or sitagliptin as add-on 
to metformin. 
 
At week 90, decreases in average A1C levels (percent), FPG levels (mg/dL), and 
body weight (kg, weight) were observed with empagliflozin 10 mg alone (-0.34; 
-30.4; -2.24, respectively) and 25 mg alone (-0.47; -27.8; -2.61, 
respectively), versus metformin (-0.56; -26.0; -1.28, respectively). When used 
as an add-on to metformin, empagliflozin showed reductions versus sitagliptin 
on A1C levels (-0.34 EMPA 10 mg; -0.63 EMPA 25 mg; and -0.40 sitagliptin); FPG 
levels (-21.3 EMPA 10 mg; -31.8 EMPA 25 mg; and -15.6 sitagliptin); and body 
weight (-3.14 EMPA 10 mg; -4.03 EMPA 25 mg; and -0.41 sitagliptin). 
 
"The alliance is leveraging the collective scientific expertise of two leading 
research-driven pharmaceutical companies to address patient needs arising from 
the growing global diabetes epidemic," said Professor Klaus Dugi, Corporate 
Senior Vice President Medicine, Boehringer Ingelheim GmbH. "We are committed to 
developing medications to help patients with diabetes throughout the course of 
their condition." 
 
The study showed empagliflozin (10 mg or 25 mg) was generally well-tolerated. 
When given for a treatment duration of at least 78 weeks and for up to 90 
weeks, adverse events (AEs) were reported in 63.2 to 74.1 percent of patients 
on empagliflozin and in 69.6 percent of patients on metformin alone or 
sitagliptin plus metformin.1 More than 90 percent of these AEs were of mild or 
moderate severity. Between 0.9 and 3.6 percent of patients on empagliflozin 
reported hypoglycemic events, versus 7.1 percent on metformin only and 5.4 
percent on sitagliptin. AEs related to urinary tract infections were reported 
in 3.8 to 12.7 percent of patients on empagliflozin, 3.6 percent of patients on 
metformin only, and 12.5 percent of patients on sitagliptin. AEs related to 
genital infections were reported in 3.0 to 5.5 percent of patients on 
empagliflozin, 1.8 percent of patients on metformin only, and none of the 
patients on sitagliptin. 
 
Empagliflozin is currently in phase 3 clinical development with over 14,500 
patients planned to be enrolled. 6 
 
Safety and Efficacy of Empagliflozin as Monotherapy or Add-On to Metformin in a 
78-Week Open-Label Extension Study in Patients With Type 2 Diabetes 
 
In this extension study, patients treated with 10 mg or 25 mg of empagliflozin 
(monotherapy or add-on to metformin), metformin alone, or sitagliptin as add-on 
to metformin in one of two 12-week trials continued on the same treatment for 
an additional 78 weeks. Patients in the 12-week trial who had received 1, 5 or 
50 mg of empagliflozin or placebo were randomized to 78 weeks of treatment with 
either 10 mg or 25 mg of empagliflozin (monotherapy [106 on 10 mg; 109 on 25 
mg] or add-on to metformin [166 on 10 mg and 166 on 25 mg]), metformin only 
(56) or sitagliptin (56). Results for empagliflozin monotherapy were compared 
with those of patients treated with metformin alone, while data among patients 
on empagliflozin plus metformin were compared with those of patients on 
sitagliptin plus metformin. 
 
About Diabetes 
 
Approximately 25.8 million Americans3 and an estimated 366 million people 
worldwide4 have type 1 or type 2 diabetes. Type 2 diabetes is the most common 
type, accounting for an estimated 90 to 95 percent of all diabetes cases.3 
Diabetes is a chronic disease that occurs when the body either does not 
properly produce, or use, the hormone insulin.5 
 
Boehringer Ingelheim and Eli Lilly and Company 
 
In January 2011, Boehringer Ingelheim and Eli Lilly and Companyannounced an 
alliance in the field of diabetes that centers on four pipeline compounds 
representing several of the largest 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 145 
affiliates and more than 44,000 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. 
 
As a central element of its culture, Boehringer Ingelheim pledges to act 
socially responsible. 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 endeavors. 
 
In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 
billion euro). R&D expenditure in the business area Prescription Medicines 
corresponds to 23.5% of its net sales. 
 
For more information, please visit http://us.boehringer-ingelheim.com and 
follow us on Twitter at http://twitter.com/boehringerus. 
 
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 
organizations. 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 programs and more--to make lives better. 
 
For more information, visit www.lillydiabetes.com. 
 
This press release contains forward-looking statements about empagliflozin for 
the treatment of type 2 diabetes. 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 empagliflozin 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. 
 
P-LLY 
 
DIA254300 
 
 
                                      ### 
 
CONTACT: 
 
Lara Crissey 
 
Director of Communications and Public Relations 
 
Boehringer Ingelheim Pharmaceuticals, Inc. 
 
Email: usnews@boehringer-ingelheim.com 
 
Phone: (203) 798-4740 
 
Tammy Hull 
 
Communications Manager 
 
Lilly Diabetes 
 
Email: hullta@lilly.com 
 
Phone: (317) 651-9116 
 
____________________________________________________________________________________________ 
 
Woerle HJ, Ferrannini E, Berk A, et al. Safety and Efficacy of Empagliflozin as 
Monotherapy or Add-On to Metformin in a 78-Week Open-Label Extension Study in 
Patients With Type 2 Diabetes. Abstract #49-LB. Presented at the American 
Diabetes Association's (ADA's) 72nd Scientific Sessions®. June 8-12, 
Philadelphia, PA. 
 
2 Rolf G, et al. In Vitro Properties and In Vivo Effect on Urinary Glucose 
Excretion of BI 10773, a Novel Selective SGLT2 Inhibitor. Abstract #521-P. 
Presented at the American Diabetes Association's (ADA's) 69th Scientific 
Sessions®. June 5-9, New Orleans, LA. 
 
3 Centers for Disease Control and Prevention. National Diabetes Fact Sheet: 
National Estimates and General Information on Diabetes and Prediabetes in the 
United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, 2011. 
 
4 International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 
2011. 
 
5 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is 
Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: 
April 11, 2012. 
 
6 Data on File. 
 
Press Release 
 
For U.S. Media 
 
Embargoed until June 9, 2012, 10:00 a.m. ET 
 
Page 4 
 
 
 
END 
 

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