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末梢動脈疾患および2型糖尿病患者を対象に、セマグルチドと呼ばれる薬剤とプラセボを比較する研究

基本情報

NCT ID
NCT04560998
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
792
治験依頼者名
Novo Nordisk A/S

概要

This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

対象疾患

Diabetes Mellitus, Type 2Peripheral Arterial Disease

介入

Semaglutide(DRUG)
Placebo (semaglutide)(DRUG)

依頼者(Sponsor)

実施施設 (12)

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan

Minamiosaka Hospital_Internal medicine

Osaka, Japan

社会医療法人誠光会 淡海ふれあい病院

Shiga, Japan

近江八幡市立総合医療センター

Omihachiman-shi, Siga, Japan

医療法人社団純英会 赤井町クリニック

Chiba-shi, Chiba, Japan

医療法人社団誠馨会新東京ハートクリニック

Chiba, Japan

医療法人 愛心会 東宝塚さとう病院

Hyōgo, Japan

Naka Kinen Clinic

Ibaraki, Japan

医療法人高橋医院 高橋医院

Hyōgo, Japan

神奈川県立循環器呼吸器病センター

Saitama, Japan

医療法人社団健心会 みなみ野循環器病院

Tokyo, Japan

Nishiyamado Keiwa Hospital_Internal Medicine

Ibaraki, Japan