A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin

Sponsor
Shandong Suncadia Medicine Co., Ltd.
Study ID
NCT06589765
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 27, 2024
Status verified
Sep 2024
Primary completion
Feb 18, 2026
Completion
Jul 18, 2026

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change from baseline in HbA1c at 32 weeks of treatment [ Time Frame: at 32 weeks ]

Central Contacts

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