Diabetes: Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 43 Presentations at the 74th American Diabetes Association Scientific Sessions® - myFOXnepa.com

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

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SOURCE Eli Lilly and Company; Boehringer Ingelheim

· Data for investigational compounds LY2963016, empagliflozin and empagliflozin/linagliptin combination tablet highlight robust alliance pipeline

· Results of several studies and pooled analyses evaluating the safety and efficacy profile of linagliptin in adults with type 2 diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, June 9, 2014 /PRNewswire/ -- More than 40 posters, abstracts and oral presentations will demonstrate the breadth and depth of the Boehringer Ingelheim (BI) and Eli Lilly and Company (NYSE: LLY) diabetes portfolio at the 74th American Diabetes Association (ADA) Scientific Sessions® in San Francisco, June 13-17. The commitment of the BI-Lilly Diabetes alliance to the care of adults with diabetes is exemplified by a focus on compounds representing several of the largest diabetes treatment classes.  

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 a new insulin glargine product being developed for the treatment of patients with type 1 and type 2 diabetes.

Details of all clinical presentations and posters are as follows:

  • Saturday, June 14, 8:00 - 10:00 a.m. PT, Oral Presentation – Basal Insulin Therapy
    • 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]
    • 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]
    • 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, June 14, 11:30 a.m. - 1:30 p.m. PT, General Poster Session
    • 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]
    • 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]
    • 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, 1:00 - 1:50 p.m. PT, titled "Pharmacokinetic/Pharmacodynamic Insulin Studies."

Empagliflozin Data
A total of 17 clinical and non-clinical abstracts for the investigational compound empagliflozin will be presented, including three late breaking abstracts. Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds, and is being investigated for the reduction of blood glucose levels in adults with type 2 diabetes. SGLT2 inhibitors remove excess glucose through the urine by blocking glucose re-absorption in the kidney.

Details of clinical presentations and posters are as follows:

  • Saturday, June 14, 9:45 a.m. PT, ADA Diabetes Care Symposium - New Drug Therapies, Innovative Management Strategies, and Novel Drug Targets
    • Improved glucose control with weight loss, lower insulin doses and no increased hypoglycemia with empagliflozin added-on to titrated multiple daily insulin injections in obese, inadequately controlled patients with T2D (Presenting Author: J. Rosenstock) [Oral No. CT-SY24]
  • Saturday, June 14, 11:30 a.m. - 1:30 p.m. PT, General Poster Session
    • SGLT2 inhibition increases urinary ACE2 levels in patients with T1D (Presenting Author: D. Cherney) [Poster No. 543-P]
    • SGLT2 inhibition with empagliflozin reduces microalbuminuria in patients with T2D (Presenting Author: D. Cherney) [Poster No. 1125-P]
  • Sunday June 15, Noon – 2:00 p.m. PT, General Poster Session
    • 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]
    • Empagliflozin for >/=76 weeks as add-on to metformin in patients with T2D (Presenting Author: L. Merker) [Poster No. 1074-P]
    • Empagliflozin for >/=76 weeks as add-on to metformin plus sulfonylurea in patients with T2D (Presenting Author: H. Haring) [Poster No. 1077-P]
    • SGLT2 inhibitor empagliflozin in type 1 diabetes: impact on diurnal glycemic patterns (Presenting Author: B. Perkins) [Poster No. 1051-P]
    • 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]
    • Efficacy and safety of empagliflozin in younger, overweight/obese patients with T2D with HbA1c >/=8% (Presenting Author: L. Merker) [Poster No. 1079-P]
    • 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]
    • The intraglomerular hemodynamic profile of hyperfiltration before and after SGLT2 inhibition in patients with T1D (Presenting Author: M. Skrtic) [Poster No. 22-LB]
    • Energy balance following SGLT2 inhibition (Presenting Author: G. Ferrannini) [Poster No. 125-LB]
  • Monday, June 16, 8:00 - 10:00 a.m. PT, Oral Presentation – SGLT2 Inhibitors
    • Empagliflozin compared with glimepiride as add-on to metformin for 2 years in patients with T2D (Presenting Author: M. Ridderstrale) [Oral No. 266-OR]
    • Empagliflozin monotherapy for >/=76 weeks in drug-naive patients with T2D (Presenting Author: M. Roden] [Oral No. 264-OR]

Poster 1030-P will be featured in a guided audio tour on Saturday, June 14, 11:30 a.m. - 12:20 p.m. PT titled "SGLT2 Inhibitors," and poster 1125-P will be featured in a guided audio poster tour on Sunday, June 15, 1:00 - 1:50 p.m. PT titled "Treatment of Complications."

Empagliflozin/Linagliptin Combination Tablet
Two late breaking abstracts for the investigational combination tablet of empagliflozin and linagliptin will be presented. If granted approval by the FDA, this combination will bring together, for the first time into one tablet, an SGLT2 inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Details of posters are as follows:

  • Sunday, June 15, Noon – 2:00 p.m. PT, General Poster Session
    • Fixed dose combinations of empagliflozin/linagliptin for 24 weeks as add-on to metformin in patients with T2DM (Presenting Author: R. DeFronzo) [Poster No. 130-LB]
    • Fixed dose combinations of empagliflozin/linagliptin for 24 weeks in drug-naive patients with T2DM (Presenting Author: A. Lewin) [Poster No. 129-LB]

Linagliptin Data
A total of 16 clinical and non-clinical abstracts for linagliptin will be presented, including one late breaking abstract. Linagliptin is a DPP-4 inhibitor, which works by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.1 Linagliptin is marketed as Tradjenta® (linagliptin) tablets in the U.S., and is an active ingredient in Jentadueto® (linagliptin/metformin HCl) tablets, a fixed-dose combination of linagliptin and metformin HCl.2

Details of clinical presentations and posters are as follows:

  • Sunday, June 15, 8:15 a.m. PT, Oral Presentation – Oral Incretin-Based Therapies
    • Oral glucose lowering with linagliptin plus metformin is a viable initial treatment strategy in patients with newly diagnosed type 2 diabetes (T2D) and marked hyperglycemia (Presenting Author: S. Ross) [Oral No. 150-OR]
  • Sunday, June 15, Noon - 2:00 p.m. PT, General Poster Session
    • 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]
    • 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]
    • 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]
    • 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]
    • Safety and tolerability of linagliptin and metformin in combination for patients with T2D (Presenting Author: S. Ross) [Poster No. 1071-P]
    • Risk of hypoglycemia 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, June 14, 12:30 - 1:20 p.m. PT, titled "Oral Agents/DPP-4 Inhibitors."

About Linagliptin
Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with T2D. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRADJENTA has not been studied in patients with a history of pancreatitis.

About Linagliptin/Metformin HCl
Linagliptin/metformin HCl, which is marketed as Jentadueto® (linagliptin and metformin hydrochloride) tablets in the U.S., is a prescription medicine that contains two diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to help improve glycemic control in adults with T2D when treatment with both linagliptin and metformin is appropriate.  JENTADUETO should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JENTADUETO has not been studied in patients with a history of pancreatitis.

What are TRADJENTA tablets?

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).

If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TRADJENTA?
Serious side effects can happen to people taking TRADJENTA, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before you start taking TRADJENTA, tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking TRADJENTA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

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 may include rash, itching, flaking or peeling; raised red patches on your skin (hives); swelling of your face, lips, tongue 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 using TRADJENTA?
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.

Especially tell 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 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.
  • rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®)^, an antibiotic that is used to treat tuberculosis.

Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.

What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose, sore throat, cough and diarrhea.  

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 Medication Guide and full Prescribing Information.

TJ CONS ISI 19JUNE2013

^The brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.

To learn more about TRADJENTA visit: www.TRADJENTA.com. For full Prescribing Information and Medication Guide visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.

What is JENTADUETO?

JENTADUETO is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to help control blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.

JENTADUETO is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JENTADUETO.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JENTADUETO?


WARNING: RISK OF LACTIC ACIDOSIS

 

Serious side effects can happen in people taking JENTADUETO. Metformin, one of the medicines in JENTADUETO, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

 

Stop taking JENTADUETO and call your doctor right away if you feel very weak or tired, have unusual muscle pain, have trouble breathing, are very sleepy, have sudden nausea and vomiting or diarrhea, feel cold, especially in your arms or legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat, as these could be symptoms of lactic acidosis.

 

You have a higher chance of getting lactic acidosis with JENTADUETO if you have kidney problems, liver problems, congestive heart failure that requires medicines, drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking, get dehydrated (lose a large amount of body fluids), have certain x-ray tests with dyes or contrast agents that are injected into your body, have surgery, have a heart attack, severe infection, or stroke, and are 80 years of age or older and have not had your kidneys tested.

Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking JENTADUETO. Pancreatitis may be severe and lead to death. Before you start taking JENTADUETO tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking JENTADUETO and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Who should not take JENTADUETO?
Do not take JENTADUETO if you:

  • have kidney problems.
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
  • are allergic to linagliptin, metformin or any of the ingredients in JENTADUETO. Symptoms of any allergic reaction may include rash, itching, flaking or peeling; raised red patches on your skin (hives); and swelling of your face, lips, tongue and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking JENTADUETO and call your doctor or go to the emergency room right away.

What should I tell my doctor before using JENTADUETO?
Before you take JENTADUETO, tell your doctor if you:

  • have kidney problems.
  • are going to get an injection of dye or contrast agents for an x-ray procedure. JENTADUETO will need to be stopped for a short time. Talk to your doctor about when you should stop JENTADUETO and when you should start JENTADUETO again.
  • have liver problems.
  • have heart problems, including congestive heart failure.
  • drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if JENTADUETO will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if JENTADUETO passes into your breast milk.
  • are older than 80 years; you should not take JENTADUETO unless your kidneys have been checked and they are normal.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO may affect the way other medicines work, and other medicines may affect how JENTADUETO works.

Especially tell your doctor if you take:

  • other medicines that can lower your blood sugar. JENTADUETO may cause serious side effects, including low blood sugar (hypoglycemia). If you take JENTADUETO 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 or insulin may need to be lowered while you take JENTADUETO.

Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.

  • rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®)^, an antibiotic that is used to treat tuberculosis.

Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

What are the possible side effects of JENTADUETO tablets?
The most common side effects of JENTADUETO include stuffy or runny nose, sore throat, and diarrhea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

JD CON ISI 12SEPT2013

Click here for full Prescribing Information, including Boxed Warning regarding risk of lactic acidosis, and Medication Guide.

To learn more about JENTADUETO visit: www.JENTADUETO.com. For full Prescribing Information and Medication Guide visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Jentadueto/Jentadueto.pdf

^The brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.

About Diabetes
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85 to 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.3

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers 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
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

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.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. 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 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.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 http://newsroom.lilly.com/social-channels.

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.

This press release contains forward looking statements about the investigational fixed-dose combination of empagliflozin and linagliptin; empagliflozin, an investigational SGLT2 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.

P-LLY
TJ610709PR

 

CONTACT:
Emily Baier, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: emily.baier@boehringer-ingelheim.com
Phone: (203) 791-5997

Shirley Johnson, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: shirley.johnson@boehringer-ingelheim.com
Phone: (203) 448-1893

Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: (317) 651-9116

References

  1. Tradjenta® (linagliptin) tablets. Prescribing Information. June 2013.
  2. Jentadueto® (linagliptin and metformin HCl) tablets. Prescribing Information. September 2013.
  3. International Diabetes Federation. Diabetes Atlas, 6th Edition. 2013.

 

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