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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

Apr 15, 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

Inclusion Criteria4

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • The decision to initiate treatment with commercially available Awiqli has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
  • Male or female with no age limitation.
  • Diagnosis of diabetes mellitus. There is no limitation for type of diabetes mellitus and prior treatment for diabetes mellitus.

Exclusion Criteria6

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Treatment with any investigational drug within 30 days prior to enrolment into the study.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Contraindication described in Japanese package insert.
  • Participants showing hypoglycaemic symptoms.
  • Participants with a history of hypersensitivity to any ingredients of this drug.

Interventions

DRUGInsulin Icodec

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

Locations(43)

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Japan, Japan

Jinnouchi Hospital_Internal Medicine

Kumamoto, Kumamoto, Japan, Japan

Miyachi Clinic

Aichi, Japan

Clinic Tosaki

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

Kimitsu Chuo Hospital_Diabetology and Endocrinology

Chiba, Japan

Soyokaze CardioVascular Medicine and Diabetes Care

Ehime, Japan

Clinic Masae Minami

Fukuoka, Japan

Ito Naika Clinic_Internal Medicine

Fukuoka, 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

Mitoyo General Hospital_Internal Medicine

Kagawa, Japan

Yokohama Rosai Hospital_Diabetes and Endocrinology

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

Kyoto University Hospital

Kyoto-shi, Kyoto, Japan

MG Clinic

Mie, Japan

Kanno Naika_Internal Medicine

Mitaka-shi, Tokyo, Japan

Minamiminowa Clinic_Internal Medicine and Endocrinology and Metabolism

Nagano, Japan

Minagawa Clinic Internal Medicine

Niigata, Japan

Kitakamiekimae Naika Clinic

Numakunai, Japan

Osaka General Hospital of West Japan Railway Company_Diabetes and Metabolism

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

Yamane Hospital

Shimane, Japan

Kikuchi Medical Clinic

Shizuoka, Japan

Aoi Clinic_Diabetes and Internal Medicine

Tokyo, Japan

The Jikei University Hospital Dept of Diabetes, Metabolic

Tokyo, Japan

Matsuura Clinic

Tokyo, Japan

Mishuku Hospital

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

Tamacenter Clinic Mirai

Tokyo, Japan

Honda Clinic_Internal Medicine

Tottori, Japan

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