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セマグルチドとNNC0480-0389の併用が2型糖尿病患者にどれほど有効であるかを検証した研究

基本情報

NCT ID
NCT05144984
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
500
治験依頼者名
Novo Nordisk A/S

概要

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes. The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies. Participants will either get: Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine). NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance. Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo. Participant must inject the study medicines themself into the stomach, thigh, or upper arm. The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study. Women can only take part in the study if they are not able to become pregnant

対象疾患

Diabetes Mellitus, Type 2

介入

NNC0480-0389(DRUG)
Semaglutide(DRUG)
Placebo (NNC080-0389)(DRUG)
Placebo (semaglutide)(DRUG)

依頼者(Sponsor)

実施施設 (6)

関西電力株式会社 関西電力病院

Osaka, Japan

医療法人平心会 ToCROMクリニック

Tokyo, Japan

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan

医療法人社団慶幸会 東新宿クリニック

Tokyo, Japan

医療法人 雄信会 よしむら循環器内科クリニック

Kumamoto, Japan

医療法人社団知正会 東京センタークリニック

Tokyo, Japan