Real-world Efficacy and Safety of Dulaglutide in Korean Patients with Type 2 Diabetes Mellitus: A Retrospective Study in a Tertiary Referral Center

Abstract

Background: This study was conducted to evaluate the efficacy and safety of once-weekly dulaglutide therapy as add-on to oral antidiabetic drugs (OADs) and basal insulin in Korean patients with type 2 diabetes mellitus (T2DM) in the real-world clinical practice.Methods: We retrospectively reviewed the medical records of 112 patients who received dulaglutide in a tertiary referral center. The primary efficacy endpoint was a change in glycated hemoglobin (HbA1c) between baseline and 6 months. The secondary endpoints were the percentage of patients achieving HbA1c <7.0% or ≤6.5% and the change of body weight at 6 months. Results: At baseline, the mean HbA1c was 8.7 % (8.8% in the add-on to OAD and 8.5% in the add-on to insulin group). The mean adjusted HbA1c at 6 months decreased by −1.13% in the overall patients (p < 0.001), and by −1.36 and −0.74% in the add-on to OAD and add-on to insulin group, respectively. A significant reduction of −2.9 kg in body weight was observed in the overall patients at 6 months (p < 0.001). Approximately 34.8% and 23.2% of patients achieved HbA1c <7.0% and ≤6.5%, respectively. Higher baseline HbA1c and no previous insulin therapy were associated with good response to dulaglutide on multivariate analysis. In subgroup analysis to evaluate the long-term efficacy of dulaglutide (n=82), the mean adjusted HbA1c decreased by −0.86% from baseline to 12 months (p < 0.001). Mild gastrointestinal issues (23.2%) were the most frequently observed adverse events.Conclusions: Dulaglutide is an effective and durable treatment option as add-on to OAD and basal insulin therapy in Korean patients with T2DM.

The effect of Dulaglutide on glycemic and weight control in patients with type 2 diabetes

“…A recent literature review investigating the real-world effectiveness of Dulaglutide reported a 0.5-2.2% reduction from baseline in HbA1c after 3 to 24 months across a number of 20 studies [19]. Two recent retrospective studies found a reduction of −1.13% [20] and −0.97% [23] in HbA1c after 6 months of Dulaglutide initiation. Different changes in HbA1c reported in these studies could be related to previous antihyperglycemic regimens associated with Dulaglutide, duration of diabetes, duration of follow-up, and factors such as lower treatment compliance and adherence.…”

“…In real-world settings, bodyweight was reduced by 2.1 to 6.4 kg across a number of 15 real-world studies including patients treated with Dulaglutide followed over periods ranging from 3 to 12 months [19]. Also, two retrospective clinical studies reported a significant reduction of −2.9 kg [20] and −2.05 kg [23] in bodyweight after 6 months of Dulaglutide treatment. Different outcomes in terms of bodyweight changes could be explained by the different previous treatments used by patients when Dulaglutide was initiated.…”

“…However, their result might not truly reflect the efficacy of Dulaglutide in all patients with type 2 diabetes who exhibit different characteristics and treatment behaviors [18]. Data from real-world clinical practice could bring new information regarding Dulaglutide effectiveness in terms of HbA1c reduction and changes in bodyweight [19,20]. Thus, the aim of our study was to investigate the effect of once-weekly Dulaglutide 1.5 mg on glycemic and weight control in type 2 diabetes patients inadequately controlled by previous antihyperglycemic treatment in real-world clinical practice.…”