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Efficacy and Safety of QLG1090 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.
Official title: A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled Clinical Trial to Evaluate Efficacy and Safety of QLG1091 Versus Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
478
Start Date
2026-04-01
Completion Date
2027-05
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
QLG1091
Oral administration once-daily.
Rybelsus
Oral administration once-daily