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
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We analyzed the efficacy and safety of once weekly dulaglutide 0.75 mg by sex in 2 randomized, controlled phase 3 studies in Japanese patients with type 2 diabetes (a 52-week monotherapy study [comparator liraglutide 0.9 mg] and a 26-week combination therapy study [comparator insulin glargine]). Females comprised 18% of patients in the monotherapy study and 29% of patients in the combination therapy study. Mean reductions from baseline in glycated hemoglobin (HbA1c) were similar between the sexes for dulaglutide- and liraglutide-treated patients (range -1.17% to -1.49%). Females had numerically greater weight loss or less weight gain than males across all treatment groups. The percentages of patients with reductions in both HbA1c and weight from baseline were also greater for females than for males in all treatment groups. In all treatment groups, the incidences of treatment-emergent adverse events tended to be greater among females than among males. No differences in the incidences of total or nocturnal hypoglycemia were observed between the sexes in any treatment group. Overall, in 2 studies in Japan, across all treatment groups it appeared that HbA1c lowering was unaffected by patient sex, while female patients had greater weight loss or less weight gain and greater incidence of adverse events, including nausea, compared to male patients. Incidences of patients discontinuing dulaglutide early due to adverse event were low (<10%) for both sexes, and no new safety concerns related to dulaglutide were identified for either sex. Therefore, the benefit/risk ratio for dulaglutide remains unchanged, positive for both sexes.
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The mechanism behind the better female response to weight reduction remains unclear, but it could potentially be associated with increased drug exposure observed in women, possibly due to their lower average body weight.
“The mechanism behind the better female response to weight reduction remains unclear, but it could potentially be associated with increased drug exposure observed in women, possibly due to their lower average body weight [57].”
From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [57]
The Discussion reports greater weight loss in females and proposes that their lower mean body weight might lead to higher drug concentrations, potentially contributing to the difference. However, it explicitly says exposure was not measured, so the claim that increased exposure was observed is unsupported. No page number is provided in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn a comparative study of dulaglutide versus liraglutide, dulaglutide seemed to provoke a more prominent weight loss effect, but in all groups examined females consistently benefited from greater weight loss compared with males.
“In more detail, in a comparative study of dulaglutide versus liraglutide, the former seemed to provoke a more prominent weight loss effect. Still, in all groups examined, females consistently benefited from greater weight loss when compared with males [−1.32 kg in females (p = 0.001) vs. + 0.09 kg in males for dulaglutide (p < 0.001) and −0.51kg (p = 0.413) vs.−0.03 kg (p = 0.014) for liraglutide,”
From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [57]
The Efficacy section reports greater mean weight loss or less weight gain in females across all treatment groups; its monotherapy figures also show greater weight loss with dulaglutide than liraglutide among females. However, the p-values attached to the weight changes in the citing sentence are identified in Figure 1 as p-values for correlations between HbA1c and weight changes, not tests of weight loss. The paper does not establish that dulaglutide produced greater weight loss than liraglutide in every group. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn an analysis of data from two randomized control trials testing monotherapy with dulaglutide versus liraglutide, more women reported overall treatment-emergent adverse events compared to men in both arms (86.5% of women vs. 61.4% of men for dulaglutide and 83.3% vs. 65.5% for liraglutide).
“In an analysis of data derived from two randomized control trials, testing monotherapy with dulaglutide versus liraglutide for the treatment of T2DM, more women reported overall treatment-emergent adverse events compared to men in both arms of the study (86.5% of women vs. 61.4% of men for dulaglutide and 83.3% vs. 65.5% for liraglutide, respectively).”
From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [57]
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Experimental — accuracy not yet measuredStudies using dulaglutide and liraglutide have generated similar findings of greater weight loss in females.
“Studies that used different representatives of the class, such as dulaglutide and liraglutide, have generated similar findings [50,57].”
From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [57]
Patients with higher percentages of GI adverse events were more likely to achieve greater weight loss.
“Interestingly, patients with higher percentages of GI AE were more likely to achieve greater weight loss.”
From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [57]
The percentage of patients having experienced episodes of nocturnal or total hypoglycemia did not differ significantly between sexes.
“In contrast to the above, the percentage of patients having experienced episodes of nocturnal or total hypoglycemia did not differ significantly between sexes [57].”
From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [57]
GI adverse events in particular occurred more frequently in women.
“GI AE in particular also occurred more frequently in women.”
From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [57]
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References 16 · Cited by 47
- Authors
- Onishi, Y., Oura, T., Matsui, A., Matsuura, J., & Iwamoto, N.
- Affiliations
- The Institute of Medical Science, Asahi Life Foundation (JP)
- Eli Lilly (Japan) (JP)
- Venue
- Endocrine Journal
- Publisher
- Japan Endocrine Society
- Published
- 2017
- Volume
- 64
- Issue
- 5
- Pages
- 553-560
- ISSN
- 0918-8959 (ISSN-L)
- 1348-4540
- OpenAlex
- W2603170664
- Cited by
- 47
- References
- 16
- Citations by year
- 2026: 9 · 2025: 12 · 2024: 9 · 2023: 7 · 2022: 2 · 2021: 1 · 2020: 3 · 2019: 1 · 2018: 2 · 2017: 1
- FWCI
- 1.51
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- Endocrine Journal (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- dulaglutide, type 2 diabetes, sex differences, HbA1c, HbA1c reduction, weight loss, nausea, adverse events, liraglutide, insulin glargine, GLP-1 receptor agonists, Japanese patients, treatment discontinuation
- MeSH terms
- Insulin Glargine, Liraglutide, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Glucagon-Like Peptides, Female, Humans, Hypoglycemic Agents, Immunoglobulin Fc Fragments, Japan, Male, Middle Aged, Recombinant Fusion Proteins, Sex Factors, Treatment Outcome
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