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毎日インスリンを使用している2型糖尿病患者を対象に、2種類のインスリン(新しい週1回投与のインスリン「インスリン・イコデック」と既存の1日1回投与のインスリン「インスリン・デグルデック」)を比較する研究調査

基本情報

NCT ID
NCT04770532
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
526
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 degludec (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 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 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 8 months. Participants will have 17 clinic visits and 13 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 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 their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

対象疾患

Diabetes Mellitus, Type 2

介入

Insulin degludec(DRUG)
Insulin Icodec(DRUG)

依頼者(Sponsor)

実施施設 (9)

Juntendo University Hospital_Tokyo

Tokyo, Japan

ゆり形成内科整形おおの

Sapporo-shi, Hokkaido, Japan

Noritake Clinic

Ushiku-shi, Ibaraki, Japan

医療法人 二田哲博クリニック姪浜

Fukuoka-shi, Fukuoka, Japan

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, Japan

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan

小山イーストクリニック

Tochigi, Japan

林眼科病院付属林内科クリニック

Chigasaki-shi, Kanagawa, Japan, Japan

さくらい循環器・内科クリニック

Chiba, Japan