General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insulin Icodec.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Insulin Icodec
Participants will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.
Primary outcome measures
- Number of Adverse Reactions (ARs) [Time frame: From baseline (week 0) to end of study (week 52)]
Secondary outcome measures (6)
- Number of Adverse Events (AEs) [Time frame: From baseline (week 0) to end of study (week 52)]
- Number of Serious Adverse Events (SAEs) [Time frame: From baseline (week 0) to end of study (week 52)]
- Number of Serious Adverse Reactions (SARs) [Time frame: From baseline (week 0) to end of study (week 52)]
- Change in Glycosylated Haemoglobin (HbA1c) [Time frame: From baseline (week 0) to end of study (week 52)]
- Change in Fasting Plasma Glucose (FPG) [Time frame: From baseline (week 0) to end of study (week 52)]
- Change in Diabetes Therapy-Related Quality Of Life (DTR-QOL) [Time frame: From baseline (week 0) to end of study (week 52)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Japan · 112 centers
- Seino Internal Medicine Clinic_Internal medicine — Koriyama-shi, Fukushima
- Abe Diabetes Clinic_Internal Medicine — Oita-shi, Oita,
- Jinnouchi Hospital_Internal Medicine — Kumamoto
- Miyachi Clinic — Aichi
- Clinic Tosaki — Aichi
- Fukuoka Naika Clinic_Internal Medicine — Aichi
- Hattori Clinic Chiryu_Diabetes and Endocrinology — Aichi
- Uenishi Internal Medicine Clinic — Aichi
- … and 104 more centers
Identifiers
NCT: NCT06807190 · NN1436-7680 · U1111-1286-0463