A 52-Week Observational Study in Japan Evaluating the Safety and Effects of Awiqli Insulin Icodec in People With Diabetes Mellitus

What this Trial Is About

Researchers are evaluating the safety and clinical effects of Awiqli Insulin Icodec in people with diabetes mellitus in Japan through a non-interventional observational study. The study focuses on real-world use of Awiqli prescribed by doctors as part of routine clinical care, with no restrictions on diabetes type or prior treatments. This research aims to gather information about adverse reactions and clinical outcomes over a one-year period. Participants will receive commercially available Awiqli once weekly, with treatment decisions made by their doctors following normal clinical practice. The study does not assign treatment but observes patients using Awiqli as prescribed. Data will be collected throughout the 52-week period to monitor safety and clinical parameters under real-world conditions. During the study, participants will be monitored for adverse reactions, serious adverse events, and changes in blood sugar control, including glycosylated hemoglobin HbA1c and fasting plasma glucose. Quality of life related to diabetes therapy will also be assessed. The study involves regular data collection over approximately one year, and participants continue with their usual care while contributing information to the study.

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