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

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-15

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Awiqli

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

Insulin Icodec

Intervention Type DRUG

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

Interventions

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Insulin Icodec

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

Intervention Type DRUG

Other Intervention Names

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Awiqli

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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