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Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study: DUET-beta study

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Abstract

Aims

This randomized, open-label, parallel-group, controlled trial compared the effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes.

Materials and methods

For 24 weeks, participants received dulaglutide (0.75 mg/week) or trelagliptin (100 mg/week), after which beta-cell function was evaluated using a glucagon stimulation test-based disposition index. The primary endpoint was the change in disposition index over the 24-week treatment period.

Results

Fifty patients with type 2 diabetes who received metformin with or without basal insulin were randomized to receive dulaglutide or trelagliptin. Forty-eight patients completed the 24-week dulaglutide (n = 23) or trelagliptin (n = 25) treatment. The dulaglutide group reduced HbA1c levels more than the trelagliptin group (dulaglutide: − 0.77% ± 0.07% vs. trelagliptin: − 0.57% ± 0.07%; p = 0.04). Change in disposition index during the 24 weeks did not differ between the groups (dulaglutide: − 0.07 ± 1.08 vs. trelagliptin: + 0.59 ± 1.04; p = 0.66), but the dulaglutide group increased HOMA2-%β levels more than the trelagliptin group (dulaglutide: + 26.2 ± 4.3% vs. trelagliptin: + 5.4 ± 4.1%; p = 0.001). The dulaglutide group showed greater body fat mass reduction than the trelagliptin group (dulaglutide: − 1.2 ± 0.3 kg vs. trelagliptin: − 0.3 ± 0.2 kg; p = 0.02) without skeletal muscle mass loss.

Conclusion

Dulaglutide and trelagliptin had similar effects on beta-cell function according to the glucagon stimulation test-based disposition index. However, dulaglutide promoted improved HOMA2-%β levels compared to trelagliptin and body fat mass was reduced without loss of skeletal muscle mass (UMIN-CTR 000024164).

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Data availability

In order to protect the privacy of the participants in this study, and because permission to share data with third parties was not obtained in the informed consent form, data from this study cannot be provided.

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Acknowledgements

This study was presented in part as a general poster session at the 78th Scientific Sessions of the American Diabetes Association, Orlando, Florida, June 22-26, 2018, and the 54th European Association for the Study of Diabetes Annual Meeting, Berlin, Germany, October 1-5, 2018.

Funding

This work was self-funded.

Author information

Authors and Affiliations

  1. Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan

    Yoshinobu Kondo & Yasuo Terauchi

  2. Department of Endocrinology and Metabolism, Chigasaki Municipal Hospital, 5-15-1 Honson, Chigasaki, Kanagawa, 253-0042, Japan

    Yoshinobu Kondo & Shinobu Satoh

  3. Tsunashima-East Internal Medicine and Diabetes Clinic, 2-2-14 Tsunashima-Higashi, Kouhoku-ku, Yokohama, Kanagawa, 223-0052, Japan

    Yoshinobu Kondo

  4. Department of Diabetes and Metabolism, Fujisawa Shonandai Hospital, 2345 Takakura, Fujisawa, Kanagawa, 252-0802, Japan

    Shinobu Satoh

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  1. Yoshinobu Kondo
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  3. Yasuo Terauchi
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Contributions

All authors participated in study design, data analysis, interpretation of study results, drafting, revision, and approval of the final version of the manuscript. All authors accept responsibility for all aspects of this work.

Corresponding author

Correspondence to Yoshinobu Kondo.

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Conflict of interest

Yoshinobu Kondo received honoraria for lectures from Novo Nordisk Pharma. Shinobu Satoh received honoraria for lectures from Novo Nordisk Pharma and Eli Lilly. Yasuo Terauchi received honoraria for lectures from MSD; Ono Pharmaceutical; Nippon Boehringer Ingelheim; Mitsubishi Tanabe Pharma; Daiichi Sankyo; Kowa; Novo Nordisk Pharma; Eli Lilly; Sanofi; Sumitomo Pharma; Bayer, and AstraZeneca, and has obtained research support from Nippon Boehringer Ingelheim; Mitsubishi Tanabe Pharma; Daiichi Sankyo; Eli Lilly; Sanofi; and Sumitomo Pharma.

Human rights statement

The protocol for this study was approved by the Institutional Review Board of Yokohama City University (date of approval: November 24, 2016, approval No. B161110001) and Chigasaki Municipal Hospital (date of approval: November 18, 2016, approval No. 2016-09), and this study was also registered in the clinical trial registry (University hospital Medical Information Network Clinical Trials Registry 000024164). All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and/or with the Helsinki Declaration of 1964 and later versions.

Informed consent

All participants were fully informed of the aims and conduct of the study. Written informed consent was obtained from all participants prior to enrollment.

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Kondo, Y., Satoh, S. & Terauchi, Y. Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study: DUET-beta study. Diabetol Int (2024). https://doi.org/10.1007/s13340-024-00717-6

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