Study: Once-Weekly Trulicity™ (dulaglutide) Provides Greater Blood Sugar Reduction Compared to Once-Daily Victoza® (liraglutide) in Japanese Patients after 52 weeks

Data to be presented at 75th American Diabetes Association Scientific Sessions®

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Jun 06, 2015, 10:00 ET

INDIANAPOLIS, June 6, 2015 /PRNewswire/ -- Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity^™ 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza^® 0.9 mg after 52 weeks of treatment. Eli Lilly and Company (NYSE: LLY) will present these data at the 75^th American Diabetes Association (ADA) Scientific Sessions in Boston.¹

"These data not only reinforce once-weekly Trulicity as a safe and efficacious GLP-1 receptor agonist, but further support the value for Japanese patients, with greater A1C reductions compared to once-daily Victoza," said Jessie Fahrbach, M.D., medical director, Lilly Diabetes. "We are pleased to present these study findings, which capture important information about a key region where type 2 diabetes is on the rise."

The study's primary objective was met, with Trulicity 0.75 mg demonstrating a greater A1C reduction from baseline compared to placebo at 26 weeks. At the final endpoint of 52 weeks, which is the focus of the data presentation at the meeting, Trulicity 0.75 mg demonstrated statistically greater A1C reductions compared to Victoza 0.9 mg, the highest approved dose in Japan (-1.39 percent vs. -1.19 percent). Additional results showed:

Trulicity 0.75 mg provided statistically greater reductions in the average self-monitored blood glucose levels compared to Victoza 0.9 mg (-53.1 mg/dL vs. -46.8 mg/dL); and
Trulicity 0.75 mg significantly lowered average post-meal blood glucose levels from baseline compared to Victoza 0.9 mg (-63.7 mg/dL vs. -55.4 mg/dL).¹

Mean body weight did not change in either treatment group.¹

Both Trulicity and Victoza were well-tolerated in the study. No cases of adjudicated pancreatitis were reported, and no new safety signals were seen. The most frequently reported adverse events were gastrointestinal-related with Trulicity 0.75 mg and Victoza 0.9 mg, including:

constipation (7.9 percent vs. 8 percent),
diarrhea (7.1 percent vs. 4.4 percent),
nausea (6.1 percent vs. 8 percent),
abdominal distension (4.3 percent vs. 5.1 percent), and
decreased appetite (0.7 percent vs. 5.8 percent). Reports of decreased appetite were significantly different between the two treatments.¹

Total hypoglycemia incidence in both treatment groups was 2.9 percent, with no severe hypoglycemia reported.¹

Japan currently ranks tenth in the world in the number of people with diabetes – an estimated 7.2 million cases. According to the International Diabetes Federation, the overall prevalence of diabetes in the Western Pacific region is expected to increase over the next 20 years. By 2035, an estimated 202 million people in the region will have diabetes, a 46 percent increase from 2014.²

A regulatory application for Trulicity in Japan is pending. Trulicity was approved by the U.S. Food and Drug Administration (FDA) in September 2014, and launched in the U.S. in November 2014. The European Commission granted marketing authorisation for Trulicity in November 2014, and launches are ongoing in the various countries.

About the Study
This Phase 3, randomized, parallel-arm, placebo-controlled, 52-week study compared the safety and efficacy of once-weekly Trulicity 0.75 mg to once-daily Victoza 0.9 mg. The primary objective of the study, conducted in 487 Japanese patients with type 2 diabetes and an average baseline A1C of 8.1 percent, was to evaluate whether Trulicity 0.75 mg was superior to placebo in reducing A1C from baseline at 26 weeks. The study also included a comparison of Trulicity and Victoza at 26 and 52 weeks. Patients initially assigned to placebo were switched to Trulicity 0.75 mg at 26 weeks for the remainder of the trial. Victoza 0.9 mg is the highest approved dose in Japan, and Trulicity 0.75 mg is the dose under review by the Japanese Pharmaceuticals and Medical Devices Agency.

Indication and Limitations of Use for Trulicity
Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks. It has not been studied in patients with a history of pancreatitis and other antidiabetic therapies should be considered. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease.

Important Safety Information for Trulicity™

WARNING: RISK OF THYROID C-CELL TUMORS

In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.

Hypersensitivity Reactions: Systemic reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice.

Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions.

Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.

The most common adverse reactions reported in >5% of Trulicity-treated patients in placebo-controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%), diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%).

Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.

Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential benefit outweighs potential risk to fetus.

Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

Please click to access Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, and Medication Guide.

Please see Instructions for Use included with the pen.

DG HCP ISI 20APR2015

About Diabetes
Approximately 29 million Americans³and an estimated 387 million people worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.²

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.

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.

P-LLY

Trulicity^™ is a trademark of Eli Lilly and Company.

Victoza^® is a registered trademark of Novo Nordisk.

This press release contains forward-looking statements about Trulicity 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 Trulicity will prove to 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.

[1] Takamura T, Miyagawa J, Odawara M, et. al. Efficacy and Safety of Once-weekly Dulaglutide versus Once-daily Liraglutide in Japanese Patients with Type 2 Diabetes. Abstract 1111-P. Presented at 75^th American Diabetes Association (ADA) Scientific Sessions; June 5-9, 2015; Boston, MA.

[2] International Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: International Diabetes Federation, 2014. http://www.idf.org/diabetesatlas.

[3] Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. Available at: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. October 2014.

Refer to: Candace Johnson, [email protected], (317) 755-9143

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