A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07082114
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • HDM1002 100 mg — DRUG
    HDM1002 tablets, 100 mg once daily, 52 weeks
  • HDM1002 200 mg — DRUG
    HDM1002 tablets, 200 mg once daily, 52 weeks
  • HDM1002 400 mg — DRUG
    HDM1002 tablets, 400 mg once daily, 52 weeks
  • Dapagliflozin (DAPA) — DRUG
    dapagliflozin 10mg will be provided

Study Details

This is a multicenter, randomized, double-blind, active-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets compared with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.

Key Dates

Start date
Jul 14, 2025
Status verified
Jul 2025
Primary completion
Feb 16, 2027
Completion
May 17, 2027

Study Design

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

Arms

  • Experimental: HDM1002 100mg
    Participants received maintenance dose of 100 mg with dose escalation starting from 50 mg HDM1002 administered orally once daily (QD)
  • Experimental: HDM1002 200mg
    Participants received maintenance dose 200 mg with dose escalation starting from 50 mg, 100 mg and then 200 mg HDM1002 administered orally QD
  • Experimental: HDM1002 400mg
    Participants received maintenance dose 400 mg with dose escalation starting from 50 mg, 100 mg, 200 mg and then 400 mg HDM1002 administered orally QD
  • Active Comparator: Dapagliflozin
    Participants received dapagliflozin 10 mg administered orally QD

Primary Outcome Measure

Change From Baseline in HbA1c at Week 40 [ Time Frame: Baseline, Week 40 ]

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