Efficacy and Safety of Once Weekly Dulaglutide in East Asian Patients with Type 2 Diabetes: Subgroup Analysis by Potential Influential Factors

Abstract

Introduction: This subgroup analysis assessed the efficacy and safety of once weekly dulaglutide 1.5 mg and 0.75 mg in East Asian patients with type 2 diabetes (T2D) stratified by key demographic and baseline characteristics. Methods: Change from baseline in glycated hemoglobin (HbA1c), fasting blood glucose (FBG) and body weight were analyzed by age (\ 60 years, C 60 years), gender (male, female), body weight (\ 70 kg, C 70 kg), BMI (\ 25 kg/ m 2 , C 25 kg/m 2), duration of diabetes (\ 10 years, C 10 years), baseline HbA1c (\ 8.5%, C 8.5%) and concomitant oral antihyperglycemic medications (OAMs; metformin only, SU only, metformin ? SU) at week 26 and 52 in East Asian patients from the AWARD-CHN2 study. Incidence of gastrointestinal adverse events (GI AEs) and hypoglycemia was evaluated. Results: A total of 422 East Asian patients with T2D were included in this subgroup analysis. At week 26, the reduction of HbA1c and FBG from baseline were similar across subgroups, except that patients with baseline HbA1c C 8.5% had greater HbA1c and FBG reductions than patients with baseline HbA1c \ 8.5%. Gender analysis showed HbA1c difference that was not clinically significant. The decrease in body weight varied across different subgroups in both dulaglutide doses; however, the difference was not clinically significant. The incidence of GI AEs and total hypoglycemia was generally similar across subgroups in both doses. A similar trend was observed at week 52 in both dulaglutide doses. Conclusions: In East Asian patients with T2D, treatment with dulaglutide (1.5 mg and 0.75 mg) demonstrated significant improvements in glycemic control irrespective of all subgroups, except baseline HbA1c, with greater HbA1c and FBG reductions in patients with higher baseline HbA1c. Dulaglutide was well tolerated with a similar safety profile to other GLP-1 receptor agonists. Trial Registration: ClinicalTrials.gov Identifier: NCT01648582.

Effect of baseline characteristics on the efficacy of dulaglutide added to basal insulin in Chinese patients with type 2 diabetes: A subgroup analysis of AWARD‐CHN3

“…Greater reductions in body weight from baseline to Week 28 were observed in patients with baseline HbA1c <8.5% versus ≥8.5%, which is consistent with previous findings in East Asian and Japanese patients, 5,6 and in patients with baseline FSG ≥7.0 to <11.1 mmol/L versus ≥11.1 mmol/L. However, changes in body weight with dulaglutide were similar irrespective of age, sex, body weight, BMI, duration of diabetes, use of concomitant oral antihyperglycaemic drugs, insulin dose and estimated glomerular filtration rate.…”

“…The significantly greater reductions in HbA1c observed in patients with baseline HbA1c ≥8.5% versus <8.5% ( p < 0.001) are consistent with data reported in patients with T2DM across seven international phase 3 dulaglutide clinical trials, 4 trials in Japanese patients, 5 and trials in patients from China or South Korea 6 . Although patients aged <60 years achieved greater reductions in HbA1c than those aged ≥60 years ( p = 0.009), no impact of age on HbA1c reduction with dulaglutide was reported in patients included in a previous study conducted in East Asia 6 …”

“…6 Although patients aged <60 years achieved greater reductions in HbA1c than those aged ≥60 years ( p = 0.009), no impact of age on HbA1c reduction with dulaglutide was reported in patients included in a previous study conducted in East Asia. 6 Greater reductions in body weight from baseline to Week 28 were observed in patients with baseline HbA1c <8.5% versus ≥8.5%, which is consistent with previous findings in East Asian and Japanese patients, 5,6 and in patients with baseline FSG ≥7.0 to interpreted with caution. The potential clinical significance of these findings will require further investigation.…”

“…The significantly greater reductions in HbA1c observed in patients with baseline HbA1c ≥8.5% versus <8.5% (p < 0.001) are consistent with data reported in patients with T2DM across seven international phase 3 dulaglutide clinical trials, 4 trials in Japanese patients, 5 and trials in patients from China or South Korea. 6 Although patients aged <60 years achieved greater reductions in HbA1c than those aged ≥60 years ( p = 0.009), no impact of age on HbA1c reduction with dulaglutide was reported in patients included in a previous study conducted in East Asia. 6 Greater reductions in body weight from baseline to Week 28 were observed in patients with baseline HbA1c <8.5% versus ≥8.5%, which is consistent with previous findings in East Asian and Japanese patients, 5,6 and in patients with baseline FSG ≥7.0 to interpreted with caution.…”

Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial

“…The same trend has been observed in the Dulaglutide study. 20 Of note, this study had a total sample size of 273 participants with limited numbers in each subgroup. As a result, this subgroup analysis was not powered to investigate the statistical treatment difference in each subgroup.…”