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
介入
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