Efficacy and safety of once‐weekly dulaglutide versus insulin glargine in mainly Asian patients with type 2 diabetes mellitus on metformin and/or a sulphonylurea: A 52‐week open‐label, randomized phase III trial

Wang, Weiqing; Nevarez, Luis A; Filippova, E. O.; Song, Ki Ho; Tao, Bei; Gu, Li-Qun; Wang, Feng; Li, Pengfei; Yang, Jun

doi:10.1111/dom.13506

Cited by 42 publications

(68 citation statements)

References 29 publications

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“…In both Chinese studies, DU (1.5/0.75 mg) has an acceptable safety and tolerability profile, which is similar to the GLP‐1RA class of drugs, suggesting a satisfactory risk‐to‐benefit ratio for DU. The findings of the present post‐hoc analysis are similar to the findings from global studies (AWARD trials) with DU and with published studies of other GLP‐1RAs.…”

Section: Discussionmentioning

confidence: 87%

“…Data from two randomized, multinational, parallel‐arm, non‐inferiority, phase III trials (AWARD‐CHN1 study [NCT01644500] and AWARD‐CHN2 study [NCT01648582]) of DU in type 2 diabetes patients were analyzed. Both studies enrolled adult type 2 diabetes patients, and were intended to assess the non‐inferiority and superiority of DU with active comparators.…”

Section: Methodsmentioning

confidence: 99%

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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

Xiao

Wang

Lai

et al. 2020

J of Diabetes Invest

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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.

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Section: Discussionmentioning

confidence: 87%

Section: Methodsmentioning

confidence: 99%

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

Xiao

Wang

Lai

et al. 2020

J of Diabetes Invest

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“…Several lines of clinical evidences suggest a better risk-to-benefit ratio of GLP-1RAs compared with traditional antidiabetic drugs, such as glimepiride, which is widely used across East Asia. GLP-1RAs are generally well tolerated, although gastrointestinal (GI) AEs are commonly observed across the class [11][12][13][14].…”

Section: Introductionmentioning

confidence: 99%

“…Dulaglutide, a long-acting glucagon-like peptide-1 receptor agonist, was approved in 2014 for the treatment of T2DM [12]. Dulaglutide has been evaluated across the diabetes treatment continuum in the Assessment of Weekly AdministRation of LY2189265 in Diabetes (AWARD) trials in mainly Caucasians patients with T2DM [9].…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, lower risk of weight gain or hypoglycemia was observed with dulaglutide compared with active comparators such as metformin, sitagliptin, exenatide twice daily, and insulin glargine. Efficacy and safety of dulaglutide were also studied in two phase III randomized trials (AWARD-China 1 [CHN1] and AWARD-CHN2 study) in Chinese adult patients with T2DM, which demonstrated significant HbA1c reduction [11,12]. However, the effects of dulaglutide in Chinese patients with T2DM and different baseline HbA1c levels (\ 8.5% and C 8.5%) have not yet been reported.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis

Yuan

Zhang

et al. 2020

Diabetes Ther

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Introduction: To evaluate the efficacy and safety of dulaglutide 0.75 and 1.5 mg in patients with type 2 diabetes mellitus (T2DM) by baseline glycated hemoglobin (HbA1c) \ 8.5% or C 8.5% after 26 weeks of treatment.Methods: Assessment of the Weekly Admin-istRation of dulaglutide in Diabetes (AWARD) China 1 (CHN1) study (NCT01644500, n = 556) included patients on dulaglutide vs. glimepiride who were treatment naïve or on monotherapy but discontinued therapy. AWARD-CHN2 (NCT01 648582, n = 591) patients were on dulaglutide vs. insulin glargine and continued on metformin and/or sulfonylurea. Mean daily dose of glimepiride and insulin glargine was 2.51 mg and 21.0 IU, respectively. Post hoc analyses were conducted based on mixed-model repeated measures using a modified intent-to-treat analysis set with only the Chinese population. Change from baseline in HbA1c and body weight was analyzed by individual study. Results: In the two studies, 70.1% of patients in AWARD-CHN1 and 59.7% in AWARD-CHN2 had baseline HbA1c \ 8.5% (mean HbA1c 7.4% and 7.6%, respectively) and 29.9% in AWARD-CHN1 and 40.3% in AWARD-CHN2 had baseline HbA1c C 8.5% (mean HbA1c 9.2% and 9.4%, respectively). In AWARD-CHN1, the HbA1c reductions at 26 weeks with baseline HbA1c \ 8.5% and C 8.5%, respectively, were dulaglutide 1.5 mg: -1.1% and -2.2%; dulaglutide 0.75 mg: -0.9% and -2.0%; glimepiride: -0.7% and -1.4%. In AWARD-CHN2, the HbA1c reductions at 26 weeks with baseline HbA1c \ 8.5% and C 8.5%, respectively, were dulaglutide 1.5 mg: -1.2% and -2.3%; dulaglutide 0.75 mg: -1.0% and -1.7%; and insulin glargine: -0.6% and -1.7%. Irrespective of baseline HbA1c, body Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11439636.Electronic supplementary material The online version of this article (https://doi.org/10.1007/s13300-020-00804-2) contains supplementary material, which is available to authorized users.

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Switching from insulin to dulaglutide therapy in patients with type 2 diabetes: A real‐world data study

Lee

Kim

Jung

et al. 2021

Diabetes Metabolism Res

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Aim Patients with type 2 diabetes (T2DM) who require injectable therapy have been conventionally treated with insulin. A glucagon‐like peptide 1 receptor agonist was recently recommended as first‐line injectable treatment, but few studies have investigated the effects of switching from insulin to dulaglutide. This study investigated the clinical efficacy and parameters affecting responses to dulaglutide as an alternative to insulin in patients with T2DM in a real‐world clinical setting. Methods Ninety‐eight patients with T2DM who were switched from insulin to dulaglutide therapy were retrospectively evaluated. Changes in HbA1c concentrations were assessed after 6 months of consistent treatment with dulaglutide. Multiple linear regression analysis was performed to evaluate parameters affecting the response to dulaglutide treatment. Results After treatment with dulaglutide for 6 months, patients experienced changes in HbA1c of −0.95% (95% confidence interval [CI]: −1.30% to −0.59%, P < 0.001) and in body weight of −1.75 kg (95% CI: −2.42 to −1.08 kg, P < 0.001). Multiple linear regression analysis showed that higher baseline HbA1c was significantly associated with a greater reduction in HbA1c. The most frequent adverse events were gastrointestinal symptoms. Conclusion Switching from insulin to dulaglutide can lead to significant improvement in HbA1c levels and body weight reduction in T2DM patients over 6 months. Higher baseline HbA1c is associated with a better clinical response to dulaglutide.

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Efficacy and safety of once‐weekly dulaglutide versus insulin glargine in mainly Asian patients with type 2 diabetes mellitus on metformin and/or a sulphonylurea: A 52‐week open‐label, randomized phase III trial

Abstract: Once-weekly dulaglutide provides greater improvement in HbA1c, with weight loss and less hypoglycaemia, than once-daily insulin glargine in a population of mainly Asian patients with T2DM who had failed to achieve optimal glycaemic control on metformin and/or a sulphonylurea.

Cited by 42 publications

References 29 publications

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

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

Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis

Switching from insulin to dulaglutide therapy in patients with type 2 diabetes: A real‐world data study

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