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心不全、肥満、2型糖尿病患者におけるセマグルチドの効果を検証する研究

基本情報

NCT ID
NCT04916470
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
617
治験依頼者名
Novo Nordisk A/S

概要

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle and physical activity. The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor. * At 6 of the visits participants will have blood samples taken. * At 5 of the visits participants will be asked to fill in a questionnaire * At 4 of the visits participants will have to do a 6-minute walking test * At 3 of the visits participants will have a test to check the heart. * participants will have their eyes checked before or at the start of the study and at the end of the study Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

対象疾患

Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

介入

Semaglutide(DRUG)
Placebo (Semaglutide)(DRUG)

依頼者(Sponsor)

実施施設 (8)

兵庫県立はりま姫路総合医療センター

Himeji-shi, Hyogo, Japan

小倉記念病院

Kitakyushu-shi,Fukuoka, Japan

近江八幡市立総合医療センター

Omihachiman-shi, Siga, Japan

医療法人春林会 華岡青洲記念病院

Sapporo-shi, Hokkaido, Japan

地方独立行政法人 大阪府立病院機構 大阪国際がんセンター

Osaka, Japan

公益財団法人田附興風会 医学研究所北野病院

Osaka-shi, Osaka, Japan

岡山大学病院

Okayama-shi, Okayama, Japan

社会医療法人社団東京巨樹の会 東京品川病院

Tokyo, Japan