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回投与のセマグルチドと比較して、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（COMBINE 2）

基本情報

NCT ID

NCT05259033

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

683

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 semaglutide 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 semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they 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 18 clinic visits, 34 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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (9)