A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female, 18-75 age years, both inclusive;
• Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
• HbA1c 7.5-11.0% (both inclusive) at screening;
• Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.
Locations
Other Locations
China
Beijing Hospital
RECRUITING
Beijing
Contact Information
Primary
Jian Lei
jian.lei.jl9@hengrui.com
00-86-518-82342973
Time Frame
Start Date: 2024-09-27
Estimated Completion Date: 2026-07-18
Participants
Target number of participants: 800
Treatments
Experimental: Treatment group A
subjects will receive HRS-7535 tablet orally at dose 1.
Experimental: Treatment group B
subjects will receive HRS-7535 tablet orally at dose 2.
Experimental: Treatment group C
subjects will receive HRS-7535 tablet orally at dose 3.
Active_comparator: Treatment group D
subjects will receive dapagliflozin tablet orally.
Related Therapeutic Areas
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.