Once-weekly dulaglutide is an effective treatment option for patients with type 2 diabetes who need to advance to injectable therapy, according to results from a Japanese study presented at the 2015 American Diabetes Association Scientific Sessions in Boston
Once-weekly dulaglutide is an effective treatment option for patients with type 2 diabetes who need to advance to injectable therapy, according to results from a Japanese study presented at the 2015 American Diabetes Association Scientific Sessions in Boston.
Related: FDA: Diabetes drugs don't need death warning
The phase 3, randomized, parallel-arm, placebo-controlled, 52-week study compared the safety and efficacy of once-weekly dulaglutide (Trulicity) 0.75 mg to once-daily liraglutide 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%, was to evaluate whether dulaglutide 0.75 mg was superior to placebo in reducing A1C from baseline at 26 weeks. The study also included a comparison of dulaglutide and liraglutide at 26 and 52 weeks. Patients initially assigned to placebo were switched to dulaglutide 0.75 mg at 26 weeks for the remainder of the trial.
At the final end point of 52 weeks, once-weekly dulaglutide 0.75 mg demonstrated significant A1c reduction (-1.39%) from baseline compared to once-daily liraglutide injection 0.9 mg (-1.19%). Additionally, dulaglutide 0.75 mg provided significantly greater reductions in the average self-monitored blood glucose levels compared to liraglutide 0.9 mg (-53.1 mg/dL vs. -46.8 mg/dL); and duraglutide 0.75 mg significantly lowered average post-meal blood glucose levels from baseline compared to liraglutide 0.9 mg (-63.7 mg/dL vs. -55.4 mg/dL).
Related: Diabetes drives traditional drug trend, specialty trend increases 20%
Both dulaglutide and liraglutide 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 dulaglutide 0.75 mg and liraglutide 0.9 mg, including: constipation, diarrhea, nausea, abdominal distension, and decreased appetite. Reports of decreased appetite were significantly different between the 2 treatments. Total hypoglycemia incidence in both treatment groups was 2.9%, with no severe hypoglycemia reported.
"In addition, patients are responding quite positively to [dulaglutide]," said Candace Johnson, communications manager, Lilly Diabetes."Healthcare professionals prescribing [dulaglutide] tell us their patients like the medicine and are seeing strong efficacy and safety results. We’ve heard from them that their patients like the ease of use [dulaglutide] provides. Our goal with the launch of [dulaglutide] is to help grow the GLP-1 receptor agonist class of medicines so more patients can reach their blood sugar goals."
Read next: Children's use of antipsychotics may increase risk of diabetes
ICER Identifies 5 Drugs with Unsupported Price Increases
December 12th 2024The Institute for Clinical and Economic Review has identified five drugs — Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz — with prices increases that are not supported by new clinical evidence, with a total of $815 million in added costs to U.S. payers in 2023.
Read More
FDA Sets Goal Date for Lymphoma Drug Columvi
December 5th 2024The combination of Columvi, gemcitabine and oxaliplatin is the first CD20xCD3 bispecific antibody to show positive results in a randomized diffuse large B-cell lymphoma phase 3 trial. The FDA’s decision is expected by July 20, 2025.
Read More