New Data Show Lilly#s Once-Weekly Trulicity(R) (dulaglutide) Solution for Injection is Effective as Add-on Treatment to Sulfonylurea

Food and Healthcare Press Releases Wednesday December 2, 2015 08:50
INDIANAPOLIS--2 Dec--PRNewswire/InfoQuest
Trulicity 1.5 mg Demonstrates Superior Efficacy in AWARD-8 Trial

New data from a completed Phase 3 trial show Trulicity(R) (dulaglutide) solution for injection 1.5 mg plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering HbA1c from baseline after 24 weeks of treatment.1 Trulicity is Eli Lilly and Company's once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes. These data, from the Trulicity AWARD-8 clinical trial, were presented for the first time today at the 2015 International Diabetes Federation (IDF) World Diabetes Congress in Vancouver, Canada.

"For patients who cannot tolerate or have contraindications to metformin, a sulfonylurea is often prescribed as first-line therapy for type 2 diabetes," said Kathleen Dungan, M.D., endocrinologist, associate professor, The Ohio State University Wexner Medical Center, and lead study author. "This study affirms that Trulicity is efficacious and well-tolerated as an add-on to sulfonylurea therapy, which can help prescribers make treatment decisions for their individual patients."

At the primary endpoint of 24 weeks, Trulicity 1.5 mg plus sulfonylurea provided superior HbA1c reduction from baseline (-1.38 percent) compared to sulfonylurea with placebo (-0.11 percent). Additionally:
  • Significantly more patients treated with Trulicity 1.5 mg plus sulfonylurea achieved an HbA1c of less than 7 percent (55.3 percent) compared to sulfonylurea with placebo (18.9 percent); and
  • Trulicity plus a sulfonylurea significantly reduced fasting serum glucose levels (the amount of sugar in the blood in a fasting state) compared to sulfonylurea with placebo (-1.70 mmol/L vs. +0.16 mmol/L).

As a secondary endpoint of the study, Trulicity plus a sulfonylurea showed weight reduction from baseline (-0.91 kg), though the difference compared to sulfonylurea with placebo did not reach statistical significance.1

The most commonly reported adverse events were gastrointestinal-related and consistent with prior Trulicity studies, including nausea (10.5 percent) and diarrhoea (8.4 percent). There were no cases of pancreatitis or pancreatic cancer in either treatment group. As expected, more patients treated with Trulicity plus a sulfonylurea experienced episodes of hypoglycaemia compared to those treated with sulfonylurea alone, though the overall incidence of documented symptomatic hypoglycaemia was low in the Trulicity group (11.3 percent) and there were no reported cases of severe hypoglycaemia in either group. 1

"The AWARD-8 study demonstrated Trulicity's safety and efficacy as add-on therapy to sulfonylurea," said Jessie Fahrbach, M.D., medical director, Lilly Diabetes. "These data add to the comprehensive body of evidence for Trulicity, reinforcing its value as a type 2 diabetes treatment option."

About the AWARD-8 Study1

This Phase 3, randomised, double-blind, placebo-controlled, 24-week study compared the efficacy and safety of once-weekly Trulicity 1.5 mg to placebo in sulfonylurea-treated patients with type 2 diabetes and inadequate glycaemic control. The primary objective of the study, in 299 patients with a mean baseline HbA1c of 8.4 percent, was to demonstrate superiority of Trulicity 1.5 mg to placebo on HbA1c reduction in patients treated with sulfonylurea monotherapy.

About Trulicity(R) (dulaglutide) Solution for Injection

Trulicity is a once-weekly, GLP-1 receptor agonist injectable prescription medicine. Trulicity is not insulin. It acts like GLP-1, a natural hormone, helping the body release its own insulin when patients eat to control blood sugar.

Trulicity comes in a pen that does not require the patient to mix, measure or handle the needle. It can be taken any time of day, with or without meals, and should be injected subcutaneously in the abdomen, thigh or upper arm.

About Diabetes

An estimated 415 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 does not either 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 solutionsfrom medicines to support programs and moreto 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.

Trulicity(R) is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

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 commercialisation. 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.

References

1. Dungan K, Weitgasser R, Manghi FP, et. al. Efficacy and Safety of Once Weekly Dulaglutide Added on to Sulfonylurea in Type 2 Diabetes (AWARD-8). Abstract 0219-PD. Presented at 2015 International Diabetes Federation (IDF) World Congress; 30 November – 4 December, Vancouver, Canada.

2. International Diabetes Federation. IDF Diabetes Atlas, 7th edn. Brussels, Belgium: International Diabetes Federation, 2015. http://www.idf.org/diabetesatlas .
Refer to: Candace Johnson, johnson_candace_a@lilly.com , (317) 755-9143
Logo - http://photos.prnewswire.com/prnh/20031219/LLYLOGO

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