NCT06807190
Recruiting
Not Applicable
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
InterventionsInsulin Icodec
DrugsInsulin Icodec
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 630
- Locations
- 122
- Primary Endpoint
- Number of Adverse Reactions (ARs)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Awiqli
Participants with diabetes mellitus will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
Intervention: Insulin Icodec (Drug)
Outcomes
Primary Outcomes
Number of Adverse Reactions (ARs)
Time Frame: From baseline (week 0) to end of study (week 52)
Measured as number of events.
Secondary Outcomes
- Number of Adverse Events (AEs)(From baseline (week 0) to end of study (week 52))
- Number of Serious Adverse Events (SAEs)(From baseline (week 0) to end of study (week 52))
- Number of Serious Adverse Reactions (SARs)(From baseline (week 0) to end of study (week 52))
- Change in Glycosylated Haemoglobin (HbA1c)(From baseline (week 0) to end of study (week 52))
- Change in Fasting Plasma Glucose (FPG)(From baseline (week 0) to end of study (week 52))
- Change in Diabetes Therapy-Related Quality Of Life (DTR-QOL)(From baseline (week 0) to end of study (week 52))
Investigators
Study Sites (122)
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