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

NCT07082114 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-07-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HDM1002 100 mg

HDM1002 tablets, 100 mg once daily, 52 weeks

DRUG

HDM1002 200 mg

HDM1002 tablets, 200 mg once daily, 52 weeks

DRUG

HDM1002 400 mg

HDM1002 tablets, 400 mg once daily, 52 weeks

DRUG

Dapagliflozin (DAPA)

dapagliflozin 10mg will be provided

Sponsors & Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-14
Primary Completion
2027-02-16
Completion
2027-05-17
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082114 on ClinicalTrials.gov