A Phase 3, Randomized, Double-blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets Compared With Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Male or female subjects between 18 and 75 years of age (inclusive).

• Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months based on the World Health Organization, and participants treated with a stable dose of metformin (with maintenance dose of at least 1500 mg/day or a maximally tolerated dose not less than 1000 mg) for at least 8 weeks prior to screening; and must be stable for at least 12 weeks prior to randomization.

• HbA1c ≥7.5% and ≤11.0% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤11.0% prior to randomization as assessed by the specified central laboratory.

• Having a body mass index (BMI) of 19.0 to 40.0 kg/m2, inclusive.

• Female participants of childbearing potential and male participants must agree to use highly effective contraception method from the day of signing the ICF and until 30 days (female) or 90 days (male) after the final dose administration.

• Able to understand and comply with protocol requirements, agree to maintain the same dietary and exercise habits throughout the trial, be willing to complete the trial in strict compliance with the clinical trial protocol and provide written informed consent.

Locations
Other Locations
China
Yueyang People's Hospital
RECRUITING
Yueyang
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2027-05-17
Participants
Target number of participants: 800
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov