Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan

Onishi, Yukiko; Oura, Tomonori; Matsui, Akiko; Matsuura, Jun; Iwamoto, Noriyuki

doi:10.1507/endocrj.ej16-0552

Cited by 25 publications

(34 citation statements)

References 16 publications

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“…Thus, this mechanism of action could be hypothesized to account for the sex‐specific differences observed. In addition, subgroup analysis of dulaglutide treatment in Japanese patients also resulted in greater weight loss in women . Future investigations would be needed to clarify the observed differences in weight loss between men and women.…”

Section: Discussionsupporting

confidence: 90%

“…A study of liraglutide in a real clinical practice context also showed no differences in HbA1c reductions between women and men, consistent with our findings . Furthermore, no difference in HbA1c changes was also observed between men and women in dulaglutide‐treated Japanese patients . Dulaglutide‐treated women from these AWARD trials had a numerically greater weight loss or less weight gain compared with men, and this is consistent with results reported with exenatide twice daily or once weekly .…”

Section: Discussionsupporting

confidence: 80%

“…14 Furthermore, no difference in HbA1c changes was also observed between men and women in dulaglutide-treated Japanese patients. 15 Dulaglutide-treated women from these AWARD trials had a numerically greater weight loss or less weight gain compared with men, and this is consistent with results reported with exenatide twice daily or once weekly. 11,12 It has been hypothesized that the differences in response may be related to interaction with other hormones known to be different between sexes, such as leptin.…”

Section: Gastrointestinal Adverse Eventssupporting

confidence: 83%

“…In addition, subgroup analysis of dulaglutide treatment in Japanese patients also resulted in greater weight loss in women. 15 Future investigations would be needed to clarify the observed differences in weight loss between men and women. tide twice daily, 11 exenatide once weekly, 12 liraglutide, 17 or albiglutide treatments.…”

Section: Gastrointestinal Adverse Eventsmentioning

confidence: 99%

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Effect of once‐weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c

Gallwitz

Dagogo‐Jack

Thieu

et al. 2017

Diabetes Obesity Metabolism

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AimsTo evaluate the efficacy and safety of dulaglutide 1.5 and 0.75 mg in patients with type 2 diabetes by subgroups of gender, duration of diabetes and baseline glycated haemoglobin (HbA1c) in the dulaglutide clinical development programme (AWARD‐1 to ‐6 and ‐8 clinical trials).MethodsChange in HbA1c was analysed by gender, duration of diabetes (<5, ≥5 years and <10, ≥10 years), and baseline HbA1c (<8.5%, ≥8.5%) in pooled and individual studies. Changes from baseline in weight, hypoglycaemia and gastrointestinal adverse events were evaluated for individual trials.ResultsIn the pooled analysis of patients treated with dulaglutide 1.5 mg at 6 months, the reductions in HbA1c from baseline were similar across gender (men: least squares [LS] mean −1.26% [95% confidence interval {CI} −1.36, −1.16]; women: LS mean −1.33% [95% CI −1.43, −1.24]) and among duration of diabetes subgroups (<5 years: LS mean −1.32% [95% CI −1.43, −1.22]; ≥5 and <10 years: LS mean −1.33% [95% CI −1.43, −1.22]; ≥10 years: −1.24% [95% CI −1.35, −1.14]). Patients with baseline HbA1c ≥8.5% had greater HbA1c reductions than patients with baseline HbA1c <8.5%, (≥8.5%: LS mean −1.86% [95% CI −1.97, −1.75]; <8.5%: LS mean −1.02% [95% CI −1.12, −0.93]). Reductions in fasting blood glucose (FBG) were consistent with HbA1c changes. Similar results were observed with dulaglutide 0.75 mg. In general, body weight changes were similar among duration of diabetes and in baseline HbA1c subgroups, respectively; women had a numerically greater weight loss or less weight gain than men with both dulaglutide doses. There was no clinically meaningful difference in hypoglycaemia trends by gender or duration of diabetes. Hypoglycaemia incidence and rate were generally lower in patients with baseline HbA1c ≥8.5% than in those with <8.5%, except for the AWARD‐4 study (combination with mealtime insulin).ConclusionsAcross the AWARD studies, dulaglutide demonstrated significant improvements in glycaemic control irrespective of gender, duration of diabetes, or baseline HbA1c, with greater HbA1c and FBG reductions in patients with a higher baseline HbA1c. Dulaglutide was well tolerated, with a safety profile similar to other glucagon‐like peptide‐1 receptor agonists.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 80%

Section: Gastrointestinal Adverse Eventssupporting

confidence: 83%

Section: Gastrointestinal Adverse Eventsmentioning

confidence: 99%

See 2 more Smart Citations

Effect of once‐weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c

Gallwitz

Dagogo‐Jack

Thieu

et al. 2017

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

show abstract

“…The adverse events associated with the treatments, such as hypoglycemia and gastrointestinal symptoms, were rarely experienced during the present study and did not affect treatment satisfaction levels. The reason for this is probably that the incidences of hypoglycemia and gastrointestinal symptoms are similar for patients in each group.…”

Section: Discussionmentioning

confidence: 98%

Improvement in treatment satisfaction after switching from liraglutide to dulaglutide in patients with type 2 diabetes: A randomized controlled trial

Takase

Nakamura

Yamamoto

et al. 2018

J of Diabetes Invest

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Aims/Introduction We compared treatment satisfaction in type 2 diabetes patients taking daily and weekly glucagon‐like peptide‐1 receptor agonists. Materials and Methods The study was a 12‐week, multicenter, open‐label, prospective, randomized, parallel‐group comparison trial. The participants were Japanese patients with type 2 diabetes being administered with the glucagon‐like peptide‐1 receptor agonist, liraglutide, daily for >3 months. Patients were randomly assigned to either continue taking liraglutide once daily (Lira group) or switch to dulaglutide once weekly (Dula group). The primary outcome was the change in the Diabetes Treatment Satisfaction Questionnaire score from baseline to week 12 in the two groups. The secondary outcomes comprised changes in the Diabetes Therapy‐Related Quality of Life score, body mass and glycemic control. Results A total of 33 participants were initially enrolled in the trial, and 31 participants completed the protocol. The change in the Diabetes Treatment Satisfaction Questionnaire score in the Dula group was significantly greater than that in the Lira group (+0.1 ± 4.7 in the Lira group vs +4.9 ± 5.2 in the Dula group; P = 0.013). The change in Diabetes Therapy‐Related Quality of Life score in the Dula group was significantly greater than that in the Lira group (−3.7 ± 6.9 vs +8.9 ± 15.1; P = 0.007). There were no significant differences between groups in the changes in body mass, plasma glucose or glycated hemoglobin. Conclusions Weekly administration of dulaglutide was superior to liraglutide with regard to treatment satisfaction in patients with type 2 diabetes, in the absence of any negative effect on glycemic control.

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Sex differences in type 2 diabetes

2023

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The prevalence of type 2 diabetes mellitus is increasing in both sexes, but men are usually diagnosed at a younger age and lower body fat mass than women. Worldwide, an estimated 17.7 million more men than women have diabetes mellitus. Women appear to bear a greater risk factor burden at the time of their type 2 diabetes diagnosis, especially obesity. Moreover, psychosocial stress might play a more prominent role in diabetes risk in women. Across their lifespan, women experience greater hormone fluctuations and body changes due to reproductive factors than men. Pregnancies can unmask pre-existing metabolic abnormalities, resulting in the diagnosis of gestational diabetes, which appears to be the most prominent risk factor for progression to type 2 diabetes in women. Additionally, menopause increases women’s cardiometabolic risk profile. Due to the progressive rise in obesity, there is a global increase in women with pregestational type 2 diabetes, often with inadequate preconceptual care. There are differences between men and women regarding type 2 diabetes and other cardiovascular risk factors with respect to comorbidities, the manifestation of complications and the initiation of and adherence to therapy. Women with type 2 diabetes show greater relative risk of CVD and mortality than men. Moreover, young women with type 2 diabetes are currently less likely than men to receive the treatment and CVD risk reduction recommended by guidelines. Current medical recommendations do not provide information on sex-specific or gender-sensitive prevention strategies and management. Thus, more research on sex differences, including the underlying mechanisms, is necessary to increase the evidence in the future. Nonetheless, intensified efforts to screen for glucose metabolism disorders and other cardiovascular risk factors, as well as the early establishment of prophylactic measures and aggressive risk management strategies, are still required for both men and women at increased risk of type 2 diabetes. In this narrative review we aim to summarise sex-specific clinical features and differences between women and men with type 2 diabetes into risk factors, screening, diagnosis, complications and treatment. Graphical abstract

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Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan

Cited by 25 publications

References 16 publications

Effect of once‐weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c

Effect of once‐weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c

Improvement in treatment satisfaction after switching from liraglutide to dulaglutide in patients with type 2 diabetes: A randomized controlled trial

Sex differences in type 2 diabetes

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