A Phase 3 clinical study investigating insulin degludec injection for subjects with Type 2 Diabetes reached primary completion on 2025-12-31. This significant milestone for trial NCT04955834 indicates the conclusion of the main data collection phase for evaluating the drug's efficacy and safety.
Background
The trial, officially titled "A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 Diabetes," is designed to assess the therapeutic potential of insulin degludec injection. This investigational drug is being developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. The study aims to gather comprehensive data on how insulin degludec injection performs in managing Type 2 Diabetes.
Trial design
The study (NCT04955834) is a Phase 3, multi-center, randomized, open-label, parallel, positive-controlled clinical trial. It enrolled 344 participants diagnosed with Type 2 Diabetes. The interventions being evaluated include insulin degludec injection and Tresiba®, which serves as a positive control arm. The trial's design allows for a direct comparison to assess the efficacy and safety profile of the investigational insulin degludec.
What this means
The primary completion of this Phase 3 trial signifies that all planned primary outcome data collection for insulin degludec injection in Type 2 Diabetes has concluded. This stage is crucial as it precedes the comprehensive analysis of the collected data. Researchers will now proceed with evaluating the extensive dataset to determine the efficacy and safety of the investigational drug. The eventual reporting of these findings will provide important insights for the treatment landscape of Type 2 Diabetes.
Source
The information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT04955834, titled "A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 Diabetes," was posted on 2025-12-31 on clinicaltrials.gov.