1型糖尿病患者を対象に、新しい週1回投与インスリン「インスリン・イコデック」と既存の1日1回投与インスリン「インスリン・デグルデック」を食事時インスリンと併用した場合の効果を比較する研究（ONWARDS 6）

基本情報

NCT ID

NCT04848480

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

582

治験依頼者名

Novo Nordisk A/S

概要

This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec 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 degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin. 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 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken. At 6 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 your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year). 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 (7)