LEL Lilly(Eli)

 
TIDMLEL 
 
Post-hoc analysis of linagliptin phase 3 data in adults with type 2 diabetes 
and albuminuria presented 
 
New analysis presented at American Diabetes Association's 72nd Scientific 
Sessions® 
 
RIDGEFIELD, Conn. and INDIANAPOLIS, June 9, 2012 /PRNewswire/ -- Boehringer 
Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company(NYSE: LLY)today 
announced results from a post-hoc analysis, which explored the clinical effect 
of linagliptin on albuminuria in patients with type 2 diabetes who had early 
diabetic nephropathy (renal disease).  The primary endpoint of the analysis was 
changes to the urinary albumin-to-creatinine ratio (UACR), which is a measure 
of renal function in patients with type 2 diabetes and diabetic nephropathy. 
 
This post-hoc analysis, which is being presented at the American Diabetes 
Association's (ADA's) 72nd Scientific Sessions®, included 227 patients with 
type 2 diabetes and diabetic nephropathy from four randomized, 24-week trials 
who were on stable treatment with one of two types of blood pressure medicines 
that are the standard treatment for diabetic renal disease - 
angiotensin-converting enzyme inhibitors (ACEs) and angiotensin receptor 
blockers (ARBs).[1]  The post-hoc analysis showed a 29 percent reduction in 
UACR with linagliptin plus ACE/ARBs, versus ACE/ARBs alone at 24 weeks (p= 
0.0305).[1]  Since this was a post-hoc analysis, it did not control for other 
contributing factors.  In addition, the linagliptin treatment group reduced 
glucose levels (as measured by a 0.71 percent change in hemoglobin A1c [HbA1c 
or A1C] versus the placebo treatment group at 24 weeks; p<0.0001).  A1C is 
measured in people with diabetes to provide an index of blood glucose control 
for the previous two to three months. 
 
"As these results are based on a post-hoc analysis, this interesting 
observation warrants further investigation," said John Smith, M.D., Ph.D., 
senior vice president for clinical development and medical affairs, Boehringer 
Ingelheim Pharmaceuticals, Inc. 
 
About the Post-hoc Analysis 
Data from four randomized, double-blind, 24-week, placebo-controlled trials of 
linagliptin monotherapy, linagliptin with add-on to metformin, linagliptin with 
add-on to metformin and sulfonylurea and a factorial study of linagliptin in 
initial combination with metformin were pooled for the analysis (n=2472) to 
explore the clinical effect of linagliptin on albuminuria in patients with type 
2 diabetes who had early diabetic nephropathy.  The primary objectives of these 
four trials were to evaluate the reduction in A1C from baseline at 24 weeks.[1] 
 
UACR was collected in the four trials as safety data.  The endpoint of this 
post-hoc analysis was the percentage change in the average (mean) UACR.  In 
this analysis, 492 (19.9 percent) patients met UACR (30 to 3,000 mg/g 
creatinine) and estimated glomerular filtration rate (eGFR; >30 mL/min/1.73 m2) 
thresholds, of whom 46 percent received stable ACE/ARB therapy (linagliptin n= 
168; placebo n=59).  Mean baseline A1C was 8.2 percent versus 8.5 percent and 
median baseline UACR was 76 versus 78 mg/g creatinine for the linagliptin and 
placebo groups, respectively.[1] 
 
The incidence of hypoglycemia was higher in the linagliptin treatment group 
(14.3%) compared with the placebo treatment group (0%). 
 
Linagliptin is marketed as Tradjenta® 5mg tablets in the U.S. 
 
To learn more about TRADJENTA and for full prescribing information visit: 
www.TRADJENTA.com, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 
1-800-542-6257. 
 
What are Tradjenta® (linagliptin) tablets?[2] 
 
TRADJENTA is a prescription medicine that is used along with diet and exercise 
to lower blood sugar in adults with type 2 diabetes. 
 
TRADJENTA is not for people with type 1 diabetes or for people with diabetic 
ketoacidosis (increased ketones in the blood or urine). 
 
It is not known if TRADJENTA is safe and effective when used with insulin. 
 
Important Safety Information 
 
Who should not take TRADJENTA? 
 
Do not take TRADJENTA if you are allergic to linagliptin or any of the 
ingredients in TRADJENTA. 
 
Symptoms of a serious allergic reaction to TRADJENTA arerash, raised red 
patches on your skin (hives), swelling of your face, lips, and throat that may 
cause difficulty breathing or swallowing.  If you have any symptoms of a 
serious allergic reaction, stop taking TRADJENTA and call your doctor right 
away. 
 
What should I tell my doctor before taking TRADJENTA? 
 
TelI your doctor if you take other medicines that can lower your blood sugar, 
such as a sulfonylurea or insulin. 
 
TRADJENTA may cause serious side effects, including low blood sugar 
(hypoglycemia). If you take TRADJENTA with another medicine that can cause low 
blood sugar, such as sulfonylurea or insulin, your risk of getting low blood 
sugar is higher. The dose of your sulfonylurea medicine or insulin may need to 
be lowered while you take TRADJENTA. 
 
Signs and symptoms of low blood sugar may include headache, drowsiness, 
weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, 
or feeling jittery. 
 
Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, 
Rifamate®), an antibiotic that is used to treat tuberculosis. 
 
TRADJENTA may affect the way other medicines work, and other medicines may 
affect how TRADJENTA works. 
 
Tell your doctor if you are pregnant or planning to become pregnant or are 
breast-feeding or plan to breast-feed. 
 
Tell your doctor about all the medicines you take,including prescription and 
non-prescription medicines, vitamins, and herbal supplements. 
 
What are the possible side effects of TRADJENTA? 
 
The most common side effects of TRADJENTA include stuffy or runny nose and sore 
throat. 
 
You are encouraged to report negative side effects of prescription drugs to the 
FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 
 
For more safety information, please see Patient Information and full 
Prescribing Information. 
 
To learn more about TRADJENTA visit: www.TRADJENTA.com.  For full prescribing 
information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ 
ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/ 
Tradjenta/Tradjenta.pdf or call Boehringer Ingelheim Pharmaceuticals, Inc. at 
1-800-542-6257. 
 
Please report any unexpected effects or product problems to the Boehringer 
Ingelheim Drug Information Unit by calling 1-800-542-6257. 
 
About Diabetes 
Approximately 25.8 million Americans[3] and an estimated 366 million people 
worldwide[4] 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 TRADJENTA tablets 
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 TRADJENTA 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 
TJ310500 
 
 
 
 
 
[1] Groop P-H, Cooper M, Perkovic V, et al.  Linagliptin Lowers Albuminuria on 
Top of Recommended Standard Treatment for Diabetic Nephropathy.  Abstract # 
953-P. Presented at the American Diabetes  Association's (ADA's) 72nd 
Scientific Sessions®. June 8-12, Philadelphia, PA. 
 
[2] Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. 
Initial US Approval: 2011. 
 
[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. IDF Diabetes Atlas, 5th Edition: The 
Global Burden. 2011. http://www.idf.org/diabetesatlas/5e/the-global-burden. 
Accessed on: May 18, 2012. 
 
[5] International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is 
Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: 
May 18, 2012. 
 
(Logo:  http://photos.prnewswire.com/prnh/20031219/LLYLOGO ) 
 
(Logo:  http://photos.prnewswire.com/prnh/20110825/DE57898LOGO ) 
 
CONTACT:  Lara Crissey, Director of Communications and Public Relations, 
Boehringer Ingelheim Pharmaceuticals, Inc., Email: 
usnews@boehringer-ingelheim.com, +1-203-798-4740, or Tammy Hull, Communications 
Manager of Lilly Diabetes, Email: hullta@lilly.com , +1-317-651-9116 
 
Press Release 
 
For U.S. Media 
 
 
 
END 
 

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