Date: 2015-06-06
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Diabetes Association Scientific Sessions in Boston, Massachusetts
Company: Eli Lilly (USA - IN)
Product: Trulicity® (dulaglutide)
Action
mechanism: peptide/glucagon-like peptide-1 (GLP-1) receptor agonist. Dulaglutide is a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It has been generated by fusion of a GLP-1 analogue to a modified human immunoglobulin fragment, resulting in a much prolonged half life. Like native GLP-1, dulaglutide leads to an enhancement of glucose-dependent insulin secretion and a reduction of glucagon release. 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. Additional regulatory applications are pending around the world.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country: Japan
Trial
details: 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.
Latest
news: * On June 6, 2015, Eli Lilly announced that 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. These data have been presented at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston. 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 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), A regulatory application for Trulicity™ in Japan is pending.
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
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
