Treatment Burden on Once-Weekly Omarigliptin Versus Daily Dipeptidyl Peptidase-4 Inhibitors in Patients with Type 2 Diabetes: Randomized Controlled Trial (ONWARD-DPP4 Study)

Hitoshi Ishii; Nozomu Kamei; Dai Shimono; Tetsuji Niiya; Takahiro Tosaki; Toru Kitazawa; Daisuke Suzuki; Yutaka Wakasa; Hiroaki Seino; Mariko Oishi; Hiroshi Ohashi; Kenshi Higami; Hiroaki Akai; ONWARD-DPP4 study investigators

doi:10.1007/s13300-023-01442-0

Treatment Burden on Once-Weekly Omarigliptin Versus Daily Dipeptidyl Peptidase-4 Inhibitors in Patients with Type 2 Diabetes: Randomized Controlled Trial (ONWARD-DPP4 Study)

Diabetes Ther. 2023 Oct;14(10):1639-1658. doi: 10.1007/s13300-023-01442-0. Epub 2023 Jul 19.

Authors

Affiliations

¹ Department of Doctor-Patient Relationships, Nara Medical University, 840 Shijo-Cho, Kashihara, Nara, 634-8521, Japan. hit3910@gmail.com.
² Department of Endocrinology and Metabolism, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Hiroshima, Japan.
³ Futata Tetsuhiro Clinic, Fukuoka, Fukuoka, Japan.
⁴ Mikannohana Clinic Diabetes, Endocrinology and Metabolism, Matsuyama, Ehime, Japan.
⁵ TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology, Nagoya, Aichi, Japan.
⁶ Internal Medicine and Cardiovascular Murai Clinic, Bunkyo-ku, Tokyo, Japan.
⁷ Department of Diabetes, Metabolism and Endocrinology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan.
⁸ STOP DM Suzuki Diabetes Clinic, Atsugi, Kanagawa, Japan.
⁹ Wakasa Medical Clinic, Kanazawa, Ishikawa, Japan.
¹⁰ Seino Internal Medical Clinic, Koriyama, Fukushima, Japan.
¹¹ Oishi Clinic, Kyoto, Kyoto, Japan.
¹² Oyama East Clinic, Oyama, Tochigi, Japan.
¹³ Higami Clinic of Rheumatology and Diabetology, Kashihara, Nara, Japan.
¹⁴ Division of Metabolism and Diabetes, Faculty of Medicine, Tohoku Medical and Pharmaceutical University, Sendai, Miyagi, Japan.

Abstract

Introduction: Preference for quality of life is important in deciding the treatment strategy for patients with type 2 diabetes mellitus. This study aimed to assess the effect of omarigliptin on patients' psychological attitudes and responses compared with daily dipeptidyl peptidase-4 inhibitors (DPP4is) by measuring the burden of pharmacotherapy using the Diabetic Treatment Burden Questionnaire (DTBQ).

Methods: Patients with type 2 diabetes mellitus who were taking daily DPP-4is were enrolled and randomized to a group that switched to omarigliptin or a group that continued daily DPP4is and were monitored for 12 weeks. The primary endpoint was the change in the DTBQ score from baseline to week 12. The secondary endpoints included changes in blood test results, medication preferences and medication adherence.

Results: The DTBQ total score significantly decreased from baseline to week 12 in both groups; however, no significant intergroup differences were observed. The DTBQ subscale, implementation and flexibility burden scores significantly decreased in the group that switched to omarigliptin, although no significant intergroup difference in the change was observed. DTBQ scores and medication preferences were associated with improvements in the DTBQ scores.

Conclusion: Although this study failed to demonstrate the improvement of DTBQ total score by switching from daily DPP4is to omarigliptin compared with continuing the daily DPP4is, the DTBQ subscale score implementation and flexibility burden score were significantly improved only in the group that switched to omarigliptin, suggesting the possibility of switching from daily DPP4is to omarigliptin to decrease the patients' medication burden.

Trial registration: jRCTs031200437.

Keywords: Dipeptidyl peptidase-4 inhibitor; Omarigliptin; Quality of life; Treatment burden; Type 2 diabetes mellitus.