Date: 2015-06-08
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston
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 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: China, Republic of Korea, Mexico, Russian Federation
Trial
details: This randomized, open-label, parallel-arm study compared the safety and efficacy of Trulicity 1.5 mg and 0.75 mg to Lantus. The primary objective of the study, conducted in 789 type 2 diabetes patients inadequately controlled on metformin and/or a sulfonylurea, was to evaluate whether Trulicity 1.5 mg was non-inferior to Lantus in reducing A1C from baseline at 26 weeks. The study enrolled participants primarily from China and also from Korea, Mexico and Russia. Participants had an average baseline A1C of 8.36 percent and continued to receive background treatment of metformin and/or a sulfonylurea.
Latest
news: * On June 8, 2015, Eli Lilly announced that new data of a study comparing Trulicity™ to Lantus® in a study of patients with type 2 diabetes and primarily enrolled from East Asia have been presented at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston. Data of the head-to-head study indicate that Trulicity™ 1.5 mg and 0.75 mg provided superior hemoglobin A1c (A1C) reduction compared to Lantus® in a study of patients with type 2 diabetes and primarily enrolled from East Asia. After 26 weeks, both doses of Trulicity® were superior to Lantus® in A1C reduction, and significantly more patients reached the recommended A1C target of less than 7 percent. A1C reductions from baseline: -1.7 percent (Trulicity 1.5 mg), -1.32 percent (Trulicity 0.75 mg), -1.15 percent (Lantus). Percentages of patients reaching target A1C levels (< 7 percent): 65 percent (Trulicity 1.5 mg), 54 percent (Trulicity 0.75 mg), 41 percent (Lantus). Patients treated with Trulicity 1.5 mg and 0.75 mg also lost an average of 1.51 kg and 0.88 kg respectively, while patients treated with Lantus gained 0.96 kg. Trulicity was well-tolerated in the study, showing fewer reports of hypoglycemia in patients treated with Trulicity 1.5 mg and 0.75 mg compared to Lantus. No severe hypoglycemia was reported. Other adverse events were gastrointestinal in nature, with more Trulicity-treated patients experiencing diarrhea (15.2 percent [Trulicity 1.5 mg], 8.4 percent [Trulicity 0.75 mg]) and nausea (8.7 percent [Trulicity 1.5 mg], 4.9 percent [Trulicity 0.75 mg]) compared to Lantus (1.6 percent [diarrhea] and 0.8 percent [nausea]). These results were consistent with previous Trulicity studies.
