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回服用薬イコセマが、インスリン・アスパルトと併用して毎日服用するインスリン・グラルギンと比較して、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 3）

基本情報

NCT ID

NCT05013229

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

679

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 glargine taken daily with insulin aspart 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 glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines 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 be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. 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 (11)