Efficacy and safety of subgroup analysis stratified by baseline HbA1c in a Japanese phase 3 study of dulaglutide 0.75 mg compared with insulin glargine in patients with type 2 diabetes

Kaneko, Shuji; Oura, Tomonori; Matsui, Akiko; Shingaki, Tomotaka; Takeuchi, Masakazu

doi:10.1507/endocrj.ej17-0189

Cited by 11 publications

(11 citation statements)

References 20 publications

(18 reference statements)

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“…In this study, baseline HbA1c was the most reliable clinical parameter for predicting the patients’ response to medication, and this finding is consistent with those of previous studies of dulaglutide [17, 23, 24] and other GLP-1 receptor agonists, such as semaglutide, albiglutide and liraglutide [25–27]. However, we have also shown a relationship between C-peptide concentration and the degree of reduction in HbA1c, suggesting that a less marked glycemic response could be expected in patients with low C-peptide levels.…”

Section: Discussionsupporting

confidence: 92%

Clinical Efficacy and Parameters Affecting the Response to Dulaglutide Treatment in Patients with Type 2 Diabetes: A Retrospective, Real-World Data Study

et al. 2019

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Introduction This study aimed to investigate the efficacy and clinical factors affecting the glycemic response to dulaglutide in type 2 diabetes (T2D) in a real-world clinical setting. Methods We conducted a retrospective study of 234 patients at the Asan Medical Center, Republic of Korea, who had T2D and initiated dulaglutide from June 2016 to December 2017. The primary outcome was the change in glycated hemoglobin (HbA1c) concentration between baseline and 6 months after the initiation of therapy. Multivariate regression analysis was used to determine the clinical parameters contributing to a superior glycemic response to dulaglutide. Results The mean age of the patients was 53, and 50% were male. Their mean baseline HbA1c, body mass index and duration of diabetes were 8.8%, 27.6 kg/m 2 and 10.2 years, respectively. The change in HbA1c between baseline and 6 months was − 0.92% (95% CI: − 1.1% to − 0.74%, p < 0.001). The reduction in body weight over the same period was −2.1 kg (95% CI: − 2.9 to − 1.3 kg, p < 0.001). Using multivariate regression analysis, baseline HbA1c was found to be a significant predictor of superior glycemic response to dulaglutide. Conclusion The use of dulaglutide was associated with a significant reduction in HbA1c and body weight over a 6-month period in a real-world clinical setting. T2D patients with higher baseline HbA1c concentrations were more likely to demonstrate good clinical responses to dulaglutide. Electronic Supplementary Material The online version of this article (10.1007/s13300-019-0658-7) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 92%

Clinical Efficacy and Parameters Affecting the Response to Dulaglutide Treatment in Patients with Type 2 Diabetes: A Retrospective, Real-World Data Study

et al. 2019

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“…These findings were also consistent with those of previous studies, which showed that dulaglutide treatment lowers blood glucose irrespective of age, sex, duration of diabetes, baseline BMI, and estimated GFR. 8,15,16,18,22 The adverse events associated with dulaglutide use reported in this study were similar to those previous reported. 23,24 The most commonly reported adverse events were gastrointestinal disorders, including nausea and dyspepsia, but these were tolerated over the period of the study.…”

Section: Discussionsupporting

confidence: 90%

“…Consistent results have been reported following subgroup analyses of data from clinical trials and observational studies of dulaglutide administration. [15][16][17][18][19][20] In previous studies of the addition of other long-acting GLP-1 RAs, including liraglutide and albiglutide, to insulin, participants with higher baseline HbA1c values also achieved larger reductions in HbA1c. 11,21 In the present analysis, other factors, such as age, sex, baseline body weight, and changes in total daily insulin dose, did not affect the change in HbA1c achieved.…”

Section: Discussionmentioning

confidence: 93%

<p>Dulaglutide as an Add-on to Insulin in Type 2 Diabetes; Clinical Efficacy and Parameters Affecting the Response in Real-World Practice</p>

Lee¹,

Cho²,

Kim³

et al. 2019

DMSO

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Purpose: For patients with type 2 diabetes (T2DM) who remain above their glycemic target on insulin therapy, a combination of insulin and a glucagon-like peptide 1 receptor agonist has been recommended. However, few studies have been conducted to determine the clinical efficacy and parameters affecting the response to this combination in a real-world setting. This study aimed to investigate the clinical efficacy and parameters affecting the glycemic response to dulaglutide as an add-on to insulin therapy for T2DM in a real-world clinical setting. Patients and methods: A retrospective study was performed in 120 patients with T2DM who had initiated dulaglutide as an add-on to insulin therapy between January 2017 and December 2018. After 6 months of treatment, the change in glycated hemoglobin (HbA1c) was evaluated. Multiple linear regression analysis was used to determine the parameters affecting the therapeutic response to dulaglutide. Results: The mean age of the patients was 55.1 years and 57.5% were male. The mean baseline HbA1c, body mass index, and duration of diabetes were 9.1%, 27.5 kg/m 2 , and 17.2 years, respectively. The change in HbA1c between baseline and 6 months was −0.97% (95% confidence interval [CI]: −1.28 to −0.66%, P<0.001), the change in body weight was −2.05 kg (95% CI: −2.93 to −1.17 kg, P<0.001), and the change in total daily insulin dose was −11.67 IU (95% CI: −14.55 to −8.78 IU, P<0.001). In multiple linear regression analysis, higher baseline HbA1c was associated with a greater reduction in HbA1c. The most frequent adverse events were gastrointestinal symptoms, but these were well-tolerated. Conclusion: Dulaglutide treatment in combination with insulin resulted in a significant improvement in HbA1c and body weight over a 6-month period in a real-world clinical setting. Higher baseline HbA1c was associated with a good clinical response.

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“…Several RCTs carried out in Japan or other Asian countries have compared the efficacy and safety of IGlar with that of GLP-1RAs [ 84 – 87 ] (Table 3 ). Consistent with global findings, GLP-1RAs had similar/slightly better efficacy to IGlar as first-line injectable therapy, and were associated with a lower incidence of hypoglycemia, weight loss (vs weight gain with IGlar), and increased incidence of gastrointestinal symptoms [ 84 , 85 , 88 ]. Other trials have shown that add-on GLP-1RAs can improve glycemic control in Japanese or mostly East Asian patients with inadequate glycemic control on insulin regimens [ 86 , 87 ].…”

Section: Insulin Glargine Vs Other Injectable Treatments In Patients supporting

confidence: 61%

Use of Insulin Glargine 100 U/mL for the Treatment of Type 2 Diabetes Mellitus in East Asians: A Review

et al. 2019

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Insulin glargine (IGlar) 100 U/mL (IGlar-100) is widely used in East Asian countries for the treatment of type 2 diabetes mellitus (T2DM) and is the gold standard of basal insulin treatment. In this review we summarize key information about clinical experience with IGlar-100 in East Asian patients with T2DM, including findings from clinical trials and postmarketing studies. We also provide recommendations and opinions on the optimal use of IGlar-100 in this population. The findings from the studies highlighted in our review indicate that IGlar-100 can be a suitable treatment option for East Asians with T2DM, from initial therapy in combination with oral antihyperglycemic medications through to different combinations and intensification models. Funding Eli Lilly and Company.

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Efficacy and safety of subgroup analysis stratified by baseline HbA1c in a Japanese phase 3 study of dulaglutide 0.75 mg compared with insulin glargine in patients with type 2 diabetes

Cited by 11 publications

References 20 publications

Clinical Efficacy and Parameters Affecting the Response to Dulaglutide Treatment in Patients with Type 2 Diabetes: A Retrospective, Real-World Data Study

Clinical Efficacy and Parameters Affecting the Response to Dulaglutide Treatment in Patients with Type 2 Diabetes: A Retrospective, Real-World Data Study

<p>Dulaglutide as an Add-on to Insulin in Type 2 Diabetes; Clinical Efficacy and Parameters Affecting the Response in Real-World Practice</p>

Use of Insulin Glargine 100 U/mL for the Treatment of Type 2 Diabetes Mellitus in East Asians: A Review

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