General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus
ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNovo Nordisk A/S
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population comprises patients who are diagnosed with diabetes mellitus and who agree to be treated with Awiqli after consultation with their physician independently from the decision to participate in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Insulin Icodec
DrugParticipants will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
Treatment groups
630 Participants
are divided into 1 treatment groupGroup A: Awiqli1 intervention
Trial outcomes
Primary outcomes
1
Number of Adverse Reactions (ARs)
Measured as number of events.
Time frame
From baseline (week 0) to end of study (week 52)Secondary outcomes
1
Number of Adverse Events (AEs)
Measured as number of events.
Time frame
From baseline (week 0) to end of study (week 52)2
Number of Serious Adverse Events (SAEs)
Measured as number of events.
Time frame
From baseline (week 0) to end of study (week 52)3
Number of Serious Adverse Reactions (SARs)
Measured as number of events.
Time frame
From baseline (week 0) to end of study (week 52)4
Change in Glycosylated Haemoglobin (HbA1c)
Measured as percentage (%) point of HbA1c.
Time frame
From baseline (week 0) to end of study (week 52)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov