Achieving the composite end‐point of glycated hemoglobin <7.0% without weight gain or hypoglycemia with once‐weekly dulaglutide in Chinese patients with type 2 diabetes: A post‐hoc analysis

Abstract

Aims/Introduction: To assess the effect of dulaglutide (DU) 1.5/0.75 mg in comparison with glimepiride (GLIM) or insulin glargine (GLAR) on the composite end-point in Chinese type 2 diabetes patients. Materials and Methods: Post-hoc analyses of two randomized phase III trials (NCT01644500 and NCT01648582) were carried out using Fisher's exact test. The primary composite end-point was the number of patients reaching glycated hemoglobin (HbA1c) <7.0%, without weight gain and hypoglycemia. Secondary composite end-points included the number of patients reaching HbA1c <7.0% without weight gain and HbA1c <7.0% without hypoglycemia. Results: Data of 1,147 Chinese type 2 diabetes patients were analyzed (NCT01644500 = 556; NCT01648582 = 591). In each analyzed trial, 40-48% of patients received DU (1.5 mg), 30-39% of patients received DU (0.75 mg) and 15-20% of patients on active comparators (GLIM/GLAR) reached the primary composite end-point at week 26 (P < 0.001 for DU vs GLIM/GLAR). At 52 weeks, 26% of patients that received DU (1.5 mg), 23% of patients that received DU (0.75 mg) and 7% of patients that received GLAR attained the primary composite end-point (P < 0.001 for DU vs GLAR). A similar trend of results was found for secondary composite end-points. Conclusions: Dulaglutide is found to be an effective therapeutic alternative for Chinese type 2 diabetes patients. Compared with GLIM/GLAR, significantly greater proportions of patients on DU attained the HbA1c target of <7.0% without weight gain or hypoglycemia.

Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naïve Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1

“…Moreover, in this post hoc analysis, compared to glimepiride, a significantly greater proportion of patients treated with dulaglutide (1.5 mg and 0.75 mg) reached a target HbA1c of \ 7.0%, with greater reductions in body weight and hypoglycemia at week 26. The finding of the present post hoc analysis is consistent with the post hoc analysis of AWARD-CHN1 and AWARD-CHN2 evaluating composite endpoints, in which 40-48% of patients on dulaglutide 1.5 mg, 30-39% of patients on dulaglutide 0.75 mg, and 15-20% of patients treated with active comparators (glimepiride/ insulin glargine) reached a target HbA1c of \ 7.0%, without weight gain or hypoglycemia at week 26 [19].…”

Advances in GLP-1 receptor agonists for the treatment of type 2 diabetes

“…The results showed that exenatide (bid) was not inferior to PIA in terms of glycemic control, but was significantly better than PIA concerning the incidence of hypoglycemia and weight control.20 Another clinical study demonstrated that lixisenatide can effectively control blood glucose, and is highly effective in treating patients with elevated blood glucose due to relatively insufficient postprandial insulin secretion.Patients who received the treatment of lixisenatide could achieve weight loss within 24 weeks and had no risk of severe hypoglycemia.21The results of a clinical study on Chinese T2DM patients showed that the proportion of patients who did not gain weight or did not experience hypoglycemia after achieving the treatment goal of HbA1c<7.0% was significantly higher in patients using liraglutide compared with glimepiride (GLIM) and glargine insulin (GLAR). 22 In another study of East Asian patients (77% Chinese population), the incidence of hypoglycemia was significantly lower with dulaglutide 1.5 mg (5.7%) and dulaglutide 0.75 mg treatment (3.6%) than with the administration of glimepiride (15.6%).99 In addition to the lower risk of hypoglycemia, it was also shown that the administration of GLP-1RAs during hypoglycemia counteracted the endothelial dysfunction, oxidative stress, and inflammatory response the hypoglycemia triggered, which are likely to be related to the antioxidant activity of GLP-1RAs23 .…”