Juan Frias, MD, breaks down results of a post-hoc analysis of the AWARD-11 study examining expanded doses of dulaglutide according to baseline HbA1c levels.
Research from an analysis of the AWARD-11 study is providing insight into the effects of increased doses of dulaglutide on HbA1c control and weight loss in patients with type 2 diabetes.
Presented at ENDO 2021, data from the post-hoc analysis helps to inform clinicians on the effect of the expand doses, which received approval in September 2020, based on baseline HbA1c categories.
With the FDA basing their approval on the results of AWARD-11, a team led by Juan Frias, MD, of the National Research Institute, sought to further evaluate the safety and efficacy of alternate doses of dulaglutide according to baseline HbA1c levels. For the purpose of analysis, HbA1c subgroups were defined as less than 8%, 8-9%, 9 to less than 10%, and 10% or greater. A mixed-effects model was used to assess change in HbA1c from baseline at weeks 36 and 52.
Results of the investigators’ analyses indicated more patients randomized to the 3 mg or 4.5 mg dose of dulaglutide achieved an HbA1c of less than 7% at 36 weeks, regardless of baseline HbA1c level. In total, more than half of the patients randomized to 4.5 mg dulaglutide in each baseline HbA1c group were able to achieve an HbA1c of less than 7%.
Additionally, investigators pointed out this apparent improvement in HbA1c control seen with 4.5 mg dose was not associated with an increase in incidence of adverse gastrointestinal events.
For more on the impact of this post-hoc analysis of AWARD-11 analysis, Endocrinology Network reached out to Juan Frias, MD, medical director of the National Research Institute.
This study, “Efficacy of Dulaglutide Expanded Doses by Baseline A1C Categories: Post Hoc Analysis of AWARD-11,” was presented virtually as part of ENDO 2021.