Investigational Doses of Lilly's Once-Weekly Trulicity® (dulaglutide) Show Promise in Delivering Powerful Efficacy in People with Type 2 Diabetes
Investigational Doses of Lilly's Once-Weekly Trulicity® (dulaglutide) Show Promise in Delivering Powerful Efficacy in People with Type 2 Diabetes Data from a Phase 2 trial will be presented for the first time at the ADA's 78th Scientific Sessions® |
[23-June-2018] |
INDIANAPOLIS, June 23, 2018 /PRNewswire/ -- Two investigational doses of Lilly's dulaglutide (4.5 mg and 3.0 mg), as well as Trulicity® (dulaglutide) 1.5 mg, provided significantly better blood sugar control with weight benefits compared to placebo in adults with type 2 diabetes.1 Data from this Phase 2 study will be presented for the first time today in an oral session at the American Diabetes Association's (ADA) 78th Scientific Sessions® in Orlando. Trulicity is Eli Lilly and Company's (NYSE: LLY) once-weekly, injectable glucagon-like peptide-1 (GLP-1) receptor agonist (RA) approved to improve blood sugar (glucose) in adults with type 2 diabetes. Trulicity should be used along with diet and exercise. "The progressive nature of type 2 diabetes often means that people must continue advancing treatment throughout the natural development of their condition," said Juan P. Frias, M.D., President and Principal Investigator, National Research Institute. "Trulicity is an effective, once-weekly GLP-1 RA option, and this study of investigational doses shows potential in providing further improved blood glucose control without changing treatment." At the study's primary endpoint of 18 weeks, the investigational dulaglutide 4.5 mg and 3.0 mg doses, as well as the currently approved Trulicity 1.5 mg dose, led to superior A1C reductions from baseline in people with type 2 diabetes who remained on treatment throughout the study* (-1.50 percent (4.5 mg), -1.47 percent (3.0 mg), -1.24 percent (1.5 mg)) compared to placebo (-0.42 percent). The investigational dulaglutide doses also led to significant weight loss (-4.4 kg (4.5 mg), -4.2 kg (3.0 mg)) compared to placebo (-1.6 kg), as did Trulicity 1.5 mg (-2.9 kg).1 The most commonly reported side effects were gastrointestinal-related and consistent with the GLP-1 RA class. These events included nausea (30.3 percent (4.5 mg), 24.1 percent (3.0 mg), 22.2 percent (1.5 mg)) and vomiting (13.2 percent (4.5 mg), 10.1 percent (3.0 mg), 11.1 percent (1.5 mg)). Trulicity 1.5 mg had a similar side effect profile to previous studies. No participants in any of the treatment groups experienced severe hypoglycemia.1 "Once-weekly Trulicity offers people with type 2 diabetes a significant opportunity to reach their blood sugar goals and achieve low hypoglycemia rates with the potential for weight loss," said Brad Woodward, M.D., senior medical director, Lilly Diabetes. "We're always looking for opportunities to provide meaningful choices for people with diabetes, which is why we're studying investigational dulaglutide doses beyond the two effective Trulicity doses already approved." The safety and efficacy of the dulaglutide investigational doses are being studied further in a large, Phase 3 clinical trial, AWARD-11. The study is expected to complete in 2019. About the Phase 2 Study Indication and Limitations of Use for Trulicity® Important Safety Information for Trulicity® Do not take Trulicity if you have had an allergic reaction to dulaglutide or any of the other ingredients in Trulicity. Trulicity should not be used in children under 18 years of age. Trulicity may cause serious side effects, including:
Tell your healthcare provider if you:
If you take too much Trulicity, call your healthcare provider or go to the nearest emergency room right away. The most common side effects with Trulicity may include: nausea, diarrhea, vomiting, abdominal pain and decreased appetite. Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of Trulicity. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 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 CON ISI 24AUG2017 About Diabetes About Lilly Diabetes About Eli Lilly and Company P-LLY Trulicity® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. *Treatment effect of dulaglutide versus placebo for all randomized subjects while on treatment without use of rescue medication was assessed by Mixed Models for Repeated Measurements (MMRM). This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about dulaglutide investigational doses as a treatment for type 2 diabetes and Lilly's current beliefs. 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 study findings to date, that Trulicity will receive additional regulatory approvals or that Trulicity will prove 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. ©LillyUSA, LLC 2018. All rights reserved. References:
Refer to: Dani Barnhizer; dbarnhizer@lilly.com; 317-607-6119
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