Dulaglutide shows efficacy in diabetes patients with poor glycemic control already taking multiple oral medications….
Patients with uncontrolled diabetes already taking multiple oral agents often require insulin therapy for better glycemic control but insulin therapy is associated with hypoglycemia and weight gain. Dulaglutide, approved by the FDA in September 2014, is a glucagon-like peptide 1 (GLP-1) receptor agonist with a once weekly administration.
To compare the safety and efficacy of dulaglutide to insulin glargine in poorly controlled type 2 diabetes patients already receiving the maximum tolerated dose of metformin and glimepiride, researchers randomly assigned 807 patients to receive once weekly 1.5mg dulaglutide, once weekly 0.75mg dulaglutide or daily insulin glargine. The primary endpoint was HbA1c change from baseline to week 52 with a noninferiority margin of 0.4%. Secondary outcomes measured changes in body weight and the safety and tolerability of the medication.
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Results for the primary endpoint showed dulaglutide 1.5mg to be superior when compared to glargine (P<0.001). Dulaglutide 0.75mg was found to be noninferior to glargine (P<0.001). Mean reductions in HbA1c at week 52 were -1.08% in the 1.5mg dulaglutide group, -0.76% in the 0.75mg dulaglutide group and -0.63% in the insulin glargine group. Change in body weight was also statistically significant in both dulaglutide groups (P<0.001) when compared to glargine. At trial completion, weight decreased by 1.8kg in the 1.5mg dulaglutide group and 1.3kg in the 0.75mg group. Those receiving insulin saw their weight increase by an average of 1.4kg. In terms of adverse events, patients receiving dulaglutide were more likely to experience nausea (P<0.001).
The results showed dulaglutide as a viable option in place of insulin therapy for poorly controlled diabetes patients on oral medications. The 1.5mg dose showed better efficacy to glargine with weight loss and less hypoglycemic events. The 0.75mg dose showed similar efficacy to glargine, but offered weight loss and fewer hypoglycemic events. While dulaglutide was associated with more gastrointestinal side effects, the frequency reported was similar to other medications in this class. With once weekly dosing, weight loss and reduced risk of hypoglycemic events, dulaglutide offers some benefits when compared to a daily insulin therapy regimen.
- Dulaglutide is a newly approved GLP-1 receptor agonist with a once weekly administration.
- This study showed dulaglutide as an alternative to insulin therapy for diabetes patients with poor glycemic control.
- Dulaglutide showed improved HbA1c lowering, weight loss and less risk of hypoglycemia.
Giorgino F et al. Efficacy and Safety of Once Weekly Dulaglutide vs Insulin Glargine in Combination with Metformin and Glimepiride in Type 2 Diabetes Patient (AWARD-2). Oral Presentation #38. EASD. 2014.