RecruitingNCT06807190

General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus

A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan

Sponsor

Novo Nordisk A/S

Enrollment

630 participants

Start Date

May 30, 2025

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus, Type 1

Summary

The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.

Eligibility

Plain Language Summary

Simplified for easier understanding

This post-market surveillance study in Japan is collecting real-world safety and effectiveness data on Awiqli — a once-weekly long-acting insulin — in people with diabetes who have been prescribed it by their doctor in routine clinical practice. **You may be eligible if...** - You have diabetes (any type) - Your doctor has already decided to prescribe Awiqli for you as part of your regular treatment - You are willing to give consent for data collection **You may NOT be eligible if...** - You have already participated in this specific study before - You are currently taking part in another clinical drug trial - You are unable or unwilling to cooperate with the study due to mental incapacity or language barriers - You have a contraindication to Awiqli as listed in the Japanese prescribing information - You are currently experiencing symptoms of low blood sugar - You have had a previous allergic reaction to any ingredient in Awiqli Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInsulin Icodec

Participants will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.

Locations(80)

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, Japan

Jinnouchi Hospital_Internal Medicine

Kumamoto, Kumamoto, Japan, Japan

Abe Diabetes Clinic_Internal Medicine

Ōita, Oita, Japan, Japan

Miyachi Clinic

Aichi, Japan

Clinic Tosaki

Aichi, Japan

Fukuoka Naika Clinic_Internal Medicine

Aichi, Japan

Uenishi Internal Medicine Clinic

Aichi, Japan

Ichinomiyanishi Hospital

Aichi, Japan

Ohisama Clinic_Aomori

Aomori, Japan

Kakizaki Tonyobyo Naika Clinic

Aomori, Japan

Chiba Central Medical Center

Chiba, Japan

Shinmatsudo Central General Hospital_Diabetes and Endocrinology

Chiba, Japan

Kimitsu Chuo Hospital_Diabetology and Endocrinology

Chiba, Japan

Soyokaze CardioVascular Medicine and Diabetes Care

Ehime, Japan

Kyushu Rosai Hospital_Diabetes and Metabolism

Fukuoka, Japan

Kitakyushu Municipal Medical Center_Endocrinology and Diabetes

Fukuoka, Japan

Steel Memorial Yawata Hospital_Diabetes Internal Medicine

Fukuoka, Japan

Okada Naika Clinic

Fukuoka, Japan

Clinic Masae Minami

Fukuoka, Japan

Ito Naika Clinic_Internal Medicine

Fukuoka, Japan

Gifu University Hospital_Diabetes and Endocrinology

Gifu, Japan

Shimizu Naika

Gunma, Japan

Takasawa Diabetes Clinic

Hokkaido, Japan

Ito Hiroshi Naika Tonyobyonaika Clinic

Hokkaido, Japan

Takabe Diabetes Clinic

Hyogogoken, Japan

Kagayaki Diabetes and Endocrinology Clinic Sannomiya_Diabetes Internal Medicine

Hyōgo, Japan

Matsuda Diabetes Clinic

Hyōgo, Japan

Hyogo Prefectural Awaji Medical Center_Diabetes and Endocrinology

Hyōgo, Japan

Ushiku Aiwa General Hospital_Diabetes and Metabolism

Ibaraki, Japan

Mitoyo General Hospital_Internal Medicine

Kagawa, Japan

Tempozan Clinic of Internal Medicine

Kagoshima-shi, Kagoshima, Japan

Teikyo Univ.HP, Mizonokuchi_Fourth Internal Medicine

Kanagawa, Japan

Yokohama Rosai Hospital_Diabetes and Endocrinology

Kanagawa, Japan

Hiyoshi Clinic_Diabetes Internal Medicine

Kanagawa, Japan

H.E.C Science Clinic

Kanagawa, Japan

Kikuchi Naika Clinic_Kanagawa

Kanagawa, Japan

Hotaruno hakuyukai Medical Corporation of Japan

Kisarazu-shi, Chiba, Japan

Kumamoto University Hospital, Diabetes, Metabo and Endo

Kumamoto-shi, Kumamoto, Japan

Kamiuchi Naika Clinic

Kyoto, Japan

Kyoto University Hospital_Department of Diabetes, Endocr

Kyoto-shi, Kyoto, Japan

MG Clinic

Mie, Japan

Kanno Naika_Internal Medicine

Mitaka-shi, Tokyo, Japan

Heiwadai Hospital_Diabetes and Internal Medicine

Miyazaki, Japan

Asama General Hospital_Diabetology

Nagano, Japan

Minamiminowa Clinic_Internal Medicine and Endocrinology and Metabolism

Nagano, Japan

Sasebo City General Hospital_Diabetes and Endocrinology

Nagasaki, Japan

Kuriya Clinic_Diabetes and Internal Medicine

Nagasaki, Japan

Minagawa Clinic Internal Medicine

Niigata, Japan

Kitakamiekimae Naika Clinic

Numakunai, Japan

Okayama Medical Center_Diabetes and Endocrinology

Okayama, Japan

Chibana Clinic

Okinawa, Japan

Osaka General Hospital of West Japan Railway Company_Diabetes and Metabolism

Osaka, Japan

Kansai Electric Power Hospital_Center for Diabetes

Osaka, Japan

Osaka General Medical Center_Diabetes and Endocrinology

Osaka, Japan

Ogawa Clinic

Osaka, Japan

Matsuda Gastroenterology and Diabetes Clinic

Osaka, Japan

Okamoto Clinic for Diabetes and Endocrinology

Ōita, Japan

Imari Arita Kyoritsu Hospital_Internal Medicine

Saga, Japan

Higashisakado Clinic_Diabetes Internal Medicine

Saitama, Japan

Matsudakai Tsurugaya Clinic, Internal medicine

Sendai-shi, Miyagi, Japan

Nagahama City Hospital_Nephrology and Metabolism

Shiga, Japan

Yamauchi Naika_Internal Medicine

Shimane, Japan

Yamane Hospital

Shimane, Japan

Kikuchi Medical Clinic

Shizuoka, Japan

Nagasaki Hospital_Internal Medicine

Tochigi, Japan

Kudanzaka Hospital_Internal Medicine

Tokyo, Japan

Aoi Clinic_Diabetes and Internal Medicine

Tokyo, Japan

The Jikei University Hospital Dept of Diabetes, Metabolic

Tokyo, Japan

Okamoto Naika Clinic

Tokyo, Japan

Matsuura Clinic

Tokyo, Japan

Mishuku Hospital_Endocrinology and Metabolism

Tokyo, Japan

Tokyo Kyosai Hospital_Diabetes and Endocrinology

Tokyo, Japan

Kanto Central Hospital of the Mutual Aid Association of Public School Teachers_Diabetes and Endocrinology

Tokyo, Japan

Tokyo Women's Medical University_Diabetes and Metabolism

Tokyo, Japan

National Center for Global Health and Medicine_Diabetes and Endocrinology

Tokyo, Japan

KAWASAKI internal medicine clinic & Diabetic

Tokyo, Japan

Tamacenter Clinic Mirai

Tokyo, Japan

Honda Clinic_Internal Medicine

Tottori, Japan

Tohoku Central Hospital_Diabetes Internal Medicine

Yamagata, Japan

Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

Yamato-shi, Kanagawa, Japan

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NCT06807190

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