| Project/Area Number |
17K08956
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Applied pharmacology
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| Research Institution | Yokohama City University |
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Principal Investigator |
Yoshinobu Kondo 横浜市立大学, 附属市民総合医療センター, 助教 (20782593)
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| Co-Investigator(Kenkyū-buntansha) |
寺内 康夫 横浜市立大学, 医学研究科, 教授 (40359609)
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| Project Period (FY) |
2017-04-01 – 2020-03-31
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| Project Status |
Completed (Fiscal Year 2019)
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| Budget Amount *help |
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2019: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2018: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2017: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
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| Keywords | 2型糖尿病 / β細胞機能 / SGLT-2阻害薬 / DPP-4阻害薬 / 糖尿病 / 臨床 / 薬理学 |
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| Outline of Final Research Achievements |
Some studies with sodium-glucose cotransporter-2 inhibitors (SGLT-2-I) and dipeptidyl peptidase-4 inhibitors (DPP-4-I) have suggested positive effects on the beta-cells. But the direct comparison between SGLT-2-I: empagliflozin (Empa) and DPP-4-I: omarigliptin (Omari) effects on beta-cell function has not yet been clarified. Therefore, we compared the effects of Empa and Omari on beta-cell function in patients with type 2 diabetes in a randomized controlled trial. In this trial, subjects received Empa 10 mg/day or Omari 25 mg/week for 24 weeks. Beta-cell function was assessed by the insulin secretion-sensitivity index-2 (ISSI-2) at baseline, 24 weeks, and 28 weeks. At 24 weeks, all patients stopped their study medication before undergoing a washout ISSI-2 evaluation for the persistence of effects. By 15 April 2020, nine patients were randomized to Empa or Omari, and seven patients completed 28 weeks of follow-up. No patients had serious adverse events. This study is still ongoing.
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| Academic Significance and Societal Importance of the Research Achievements |
2型糖尿病は進行性の病態であり、2型糖尿病患者のβ細胞機能は年間約4％ずつ低下してゆく。 β細胞機能の低下は血糖管理を困難にし、糖尿病合併症の進行を促進してしまうため、β細胞機能の保護、改善が課題となっている。 本検討により、SGLT-2阻害薬、DPP-4阻害薬によるβ細胞機能への効果を明らかにすることは、2型糖尿病の病態の根幹であるβ細胞機能の改善につながり、糖尿病発症予防への応用が期待される。
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