インスリン・イコデックとセマグルチドの配合剤である新しい週1回投与薬イコセマが、週1回投与のインスリン・イコデックと比較して、2型糖尿病患者の血糖値をどの程度コントロールできるかを調査する研究

基本情報

NCT ID

NCT05352815

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

1,291

治験依頼者名

Novo Nordisk A/S

概要

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin icodec. Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. Participants will get IcoSema or insulin icodec, which participants must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 21 clinic visits, 31 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (17)