これまでインスリンを使用したことのない2型糖尿病患者を対象に、2種類のインスリン（新しいインスリン「インスリン・イコデック」と既存のインスリン「インスリン・グラルギン」）を比較する研究調査

基本情報

NCT ID

NCT04460885

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

984

治験依頼者名

Novo Nordisk A/S

概要

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

対象疾患

介入

依頼者（Sponsor）

実施施設 (15)