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Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Summary
The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
Official title: A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-07-25
Completion Date
2027-03
Last Updated
2026-01-02
Healthy Volunteers
No
Conditions
Interventions
HRS9531
HRS9531-low dose
HRS9531
HRS9531-high dose
Placebo
Placebo
Locations (1)
Perking University Peoples' Hospital
Beijing, Beijing Municipality, China