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Clinical Trial
. 2020 May;11(3):647-652.
doi: 10.1111/jdi.13187. Epub 2020 Jan 3.

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

Xinhua Xiao  1 , Changjiang Wang  2 , Xiaoyang Lai  3 , Bin Zhang  4 , Liqun Gu  4 , Jianing Hou  5 , Zhiguang Zhou  6
Affiliations
Clinical Trial

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

Xinhua Xiao et al. J Diabetes Investig. 2020 May.

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.

Keywords: Composite end-point; Dulaglutide; Type 2 diabetes.

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Conflict of interest statement

BZ and JNH are employees of Eli Lilly and Company. LQG was an employee of Eli Lilly and Company at the time of manuscript preparation. The other authors declare no conflict if interest.

Figures

Figure 1
Figure 1
Proportion of patients achieving the composite end‐point of glycated hemoglobin <7%, no weight gain and no hypoglycemia. Hypoglycemia with blood glucose ≤3.9 mmol/L or any report of severe hypoglycemia, modified intention‐to‐treat and Fisher’s exact test versus active comparator: ***P < 0.001. DU, dulaglutide; GLAR, insulin glargine; GLIM, glimepiride; HbA1c, glycated hemoglobin; mono, monotherapy; OAD, oral antihyperglycemic drug.
Figure 2
Figure 2
Proportion of patients achieving the composite end‐point of (a) glycated hemoglobin <7.0% and no weight gain, (b) glycated hemoglobin <7.0% and no hypoglycemia. Hypoglycemia with blood glucose ≤3.9 mmol/L or any report of severe hypoglycemia, modified intention‐to‐treat, Fisher’s exact test versus active comparator: *P < 0.05, ***P < 0.001. DU, dulaglutide; GLAR, insulin glargine; GLIM, glimepiride; mono, monotherapy; OAD, oral antihyperglycemic drug.
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