Actively Recruiting
Phase IIIb Study Comparing GZR4 and Insulin Icodec in Adults with Type 2 Diabetes Treated with Basal Insulin
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-11-25
300
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and patient-reported outcomes of GZR4 compared to Insulin Icodec in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with basal insulin. This Phase IIIb clinical study aims to better understand how these treatments perform, either alone or with other non-insulin antidiabetic agents, in managing blood sugar levels in this population. The study involves two groups one receiving GZR4 and the other receiving Insulin Icodec. Both treatments are administered subcutaneously once weekly using a treat-to-target dosing approach. Participants will continue their basal insulin treatment during the study period. Participants will be monitored over 26 weeks, with researchers measuring changes in HbA1c levels from baseline to week 26 as the primary outcome. Secondary outcomes include tracking hypoglycemia events, adverse events, and changes in weight. Safety and treatment effects will be assessed through regular visits and evaluations throughout the study period.
CONDITIONS
Brief Title
A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
Research Team
J
juan wu
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