Results from dulaglutide’s sixth AWARD trial showed once-weekly dulaglutide 1.5mg was non-inferior to once-daily liraglutide 1.8mg when compared to metformin….
Consistent with the study, treatment with dulaglutide, a long-acting GLP-1 receptor agonist, resulted in a greater decrease in a patient’s hemoglobin A1c (HbA1c) when compared to metformin. The AWARD-3 study was funded by Lilly and was designed to compare dulaglutide’s efficacy and safety compared to metformin in patients with early stage type 2 diabetes. This 52-week study randomly assigned 807 patients to receive weekly injections of dulaglutide, 1.5mg or 0.75mg, or metformin plus an injection placebo. In order to be eligible, patients had to be diagnosed with type 2 diabetes for more than three months but less than five years. Additionally, they had to have a baseline HbA1c between 6.5% and 9.5%, and had to be treated with diet and exercise alone or one oral antihyperglycemic medication. The results showed that at week 26, the groups who were treated with 1.5mg and 0.75mg of dulaglutide had a significantly greater decrease in mean HbA1c compared to those who were treated with metformin. Yielding a 0.78% for groups with 1.5mg of dulaglutide, 0.71% for 0.75mg of dulaglutide, and 0.56% for metformin; p<0.25 for both. Furthermore, a similar decrease in body weight was observed in patients with dulaglutide 1.5mg and those with metformin. Similar common side effects were reported including nausea, diarrhea, and vomiting. No severe hypoglycemic event was reported.
An endocrinologist at Massachusetts General Hospital in Boston, Dr. Seth Berkowitz, commented, "Because the study did not look at long-term outcomes like preventing diabetes complications (eye, kidney, or heart disease), which metformin has been shown to do, it does not provide enough evidence to select routinely dulaglutide over metformin for single-agent therapy of diabetes…. While it is certainly a valuable contribution to have another agent for blood sugar lowering, metformin will likely remain preferred first line agent because of its proven track record for long-term benefits and safety, much lower cost, and convenience."
Currently, dulaglutide has been submitted for approval to the U.S. Food and Drug Administration, the European Medicines Agency, and other regulatory bodies. It will be marketed as Trulicity upon approval.
- At week 26, the groups who were treated with 1.5mg and 0.75mg had a significantly greater decrease in mean HbA1c compared to those who were treated with metformin
- Lilly released results stating dulaglutide’s sixth AWARD trial showed once-weekly dulaglutide 1.5mg was non-inferior to once-daily liraglutide 1.8mg.
Presented at the American Diabetes Association’s 74th Scientific Sessions, June, 2014