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

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin Icodec

• Registration Number: NCT06807190
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study Start: 2025-02-01
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04
• Primary Completion: 2027-07-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 630

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Adverse Reactions (ARs)	From baseline (week 0) to end of study (week 52)	Measured as number of events.

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs)	From baseline (week 0) to end of study (week 52)	Measured as number of events.
Number of Serious Adverse Events (SAEs)	From baseline (week 0) to end of study (week 52)	Measured as number of events.
Number of Serious Adverse Reactions (SARs)	From baseline (week 0) to end of study (week 52)	Measured as number of events.
Change in Glycosylated Haemoglobin (HbA1c)	From baseline (week 0) to end of study (week 52)	Measured as percentage (%) point of HbA1c.
Change in Fasting Plasma Glucose (FPG)	From baseline (week 0) to end of study (week 52)	Measured as milligrams per decilitre (mg/dL).
Change in Diabetes Therapy-Related Quality Of Life (DTR-QOL)	From baseline (week 0) to end of study (week 52)	DTR-QOL is a Japanese questionnaire assessing the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 questions and the response scale is a 7-point scale (1: strongly agree to 7: strongly disagree). The score of each item will be reversed so that "7: strongly disagree" represents the highest/desirable QOL. The total score, after simple addition of the item scores, is converted to 0 to 100 (best-case response is 100; worst case response is 0).