Efficacy and safety of dulaglutide 3.0 mg and 4.5 mg in patients age < 65 and ≥ 65 years: Post hoc analysis of the AWARD-11 trial
Diabetes, Obesity and Metabolism — Frias JP, Bonora E, Ruiz LN, et al. | June 24, 2021
This study was undertaken to evaluate the effectiveness and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥ 65 years). Researchers recruited a total of 1,842 patients in this post hoc analysis, 438 were ≥ 65 years and 1,404 were < 65 years old. They used intent-to-treat (ITT) population while on-treatment without rescue medication for all efficacy analyses; the ITT population without rescue medication was used for hypoglycemia analyses; all other safety analyses used the ITT population. This study’s findings demonstrate that dulaglutide doses of 3.0 or 4.5 mg provided clinically relevant, dose-related improvements in HbA1c and body weight with no significant treatment-by-age interactions and with a similar safety profile across age subgroups.