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General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus | Clinical Trials | Clareo Health

RECRUITING

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

NCT06807190•Novo Nordisk A/S

View on ClinicalTrials.gov

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

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.

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

Key Dates

Start Date

April 15, 2025

Primary Completion Date

July 31, 2027

Completion Date

January 31, 2028

Last Updated

October 14, 2025

Enrollment

630

ESTIMATED participants

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Icodec

DRUG

Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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