News Release

INDIANAPOLIS, June 13, 2020 /PRNewswire/ -- New real-world data showed Trulicity^® (dulaglutide) had significantly higher adherence and longer persistence compared to weekly injections of semaglutide or exenatide (BCise pen) in people with type 2 diabetes new to GLP-1 receptor agonist (RA) treatment.¹ Eli Lilly and Company (NYSE: LLY) presented these data today during the American Diabetes Association's (ADA) 80^th Scientific Sessions^®.

The real-world study comparing adherence and persistence used U.S. claims data of people with type 2 diabetes initiating weekly injectable treatment with Trulicity, semaglutide or exenatide.¹ Matched cohorts were well balanced for characteristics such as age, gender, adapted Diabetes Complications Severity Index (aDCSI) score and select comorbidities.

At six months, people taking Trulicity showed higher adherence and persistence than those taking semaglutide or exenatide. Further, significantly fewer people discontinued treatment with Trulicity compared to semaglutide or exenatide.¹

Trulicity versus injectable semaglutide:

• Adherence: 59.7 percent (Trulicity) versus 42.7 percent (semaglutide).
• Persistence: 143.6 days (Trulicity) versus 129.9 days (semaglutide).
• Treatment discontinuation: 30.8 percent (Trulicity) versus 40.8 percent (semaglutide).

Trulicity versus exenatide:  

• Adherence: 58.1 percent (Trulicity) versus 40.3 percent (exenatide).
• Persistence: 142 days (Trulicity) versus 121.4 days (exenatide).
• Treatment discontinuation: 32.1 percent (Trulicity) versus 49.4 percent (exenatide).

"Type 2 diabetes is a progressive and personal condition and real-world studies are critical to help us further understand people's experiences with the condition and treatment," said Leonard Glass, M.D., F.A.C.E., vice president of Medical Affairs, Lilly. "This real-world study reinforces the value of the simple approach of once-weekly Trulicity and the long-term impact it can have on not only the treatment experience of people with diabetes, but also on outcomes."

About the Adherence and Persistence Study
The retrospective, real-world, observational study used U.S. claims from the HealthCore Integrated Research Database (HIRD^®) between August 2017 and June 2019 and the primary objective was to compare adherence and persistence over six months among people with type 2 diabetes initiating once-weekly glucagon-like peptide-1 receptor agonists, Trulicity (1.5 mg and 0.75 mg) to semaglutide (1 mg and 0.25/0.5 mg) and exenatide. Kaplan-Meier plot and Cox Proportional Hazard model were used to examine medication persistence. Trulicity users were propensity-matched 1:1 to semaglutide users (3,852 pairs) or exenatide users (1,879 pairs) users. Matched cohorts were balanced in baseline characteristics. People studied were 18 years or older and matched according to characteristics including baseline age, gender, aDCSI score and select comorbidities. 

PURPOSE AND SAFETY SUMMARY WITH WARNINGS

Important Facts About Trulicity® (Trῡ-li-si-tee).  It is also known as dulaglutide.

TRULICITY is an injectable prescription medicine for adults with type 2 diabetes used to improve blood sugar (glucose) and used to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors.

• You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm. Use Trulicity together with the diet and exercise that your doctor recommends. Trulicity is not insulin.

Warnings

Trulicity may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. If you have a symptom, tell your doctor.

• Do not use Trulicity if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity.

Ask your doctor how to recognize the serious side effects below and what to do if you think you have one:

Inflamed pancreas (pancreatitis). Stop using Trulicity and call your healthcare provider right away if you have severe pain in your stomach area (abdomen), with or without vomiting, that will not go away. You may feel the pain from your abdomen to your back.

Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Trulicity.

Low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include dizziness or light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability or mood changes.

Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms of a serious allergic reaction which may include: swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Acute kidney injury. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration). This may cause kidney problems to get worse.

Severe stomach problems. Trulicity may cause stomach problems, which could be severe.

Common side effects

The most common side effects of Trulicity include nausea, diarrhea, vomiting, abdominal pain and decreased appetite.

These are not all the possible side effects of Trulicity.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

• Your healthcare provider should show you how to use Trulicity before you use it for the first time.
• Before you use Trulicity, talk to your doctor about low blood sugar and how to manage it.

 Review these questions with your doctor:

• Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy?
• Do you take other diabetes medicines, such as insulin or sulfonylureas?
• Do you take any other prescription medicines or over-the-counter drugs, vitamins or herbs?

Review the list below with your doctor. Trulicity may not be right for you if:

• You are pregnant or plan to become pregnant or breastfeeding or plan to breastfeed.
• You have type 1 diabetes or diabetic ketoacidosis.
• You have or have had an inflamed pancreas (pancreatitis).
• You have severe intestinal or stomach problems, such as slowed emptying or problems with digesting food. 
• You are a child under 18 years old.

 How to take

• Read the Instructions for Use that come with Trulicity.
• Use Trulicity exactly as your doctor says.
• Do not share your Trulicity pen, syringe or needles with another person.
• Do not give Trulicity to other people.
• If you take too much Trulicity, call your healthcare provider or seek medical advice promptly.

Learn more

For more information, call 1-844-TRU-INFO (1-844-878-4636) or go to www.TRULICITY.com.

This summary provides basic information about Trulicity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Trulicity and how to take it. Your doctor is the best person to help you decide if Trulicity is right for you.

Trulicity^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

DG CON BS FEB2020

About Diabetes
Approximately 34 million Americans² (just over 1 in 10) and an estimated 463 million adults worldwide³ have diabetes. Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone². Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.

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, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

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 lilly.com and lilly.com/newsroom. P-LLY

Trulicity^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Trulicity as a treatment for people with type 2 diabetes and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Trulicity will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

¹ Mody R, Yu M, et. al. Dulaglutide has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-month Follow-up from US Real-World Data. Abstract 928-P. Presented virtually at the 80th American Diabetes Association Scientific Sessions; June 12-16.
² Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2020.
³ International Diabetes Federation. IDF Diabetes Atlas, 9^th edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at: http://diabetesatlas.org.

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