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To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

NCT06481085 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-07-28

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo controlled, parallel group study, which aims to provide data on efficacy, safety and pharmacokinetics (PK) of multiple dose levels of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise.

Conditions

Interventions

DRUG

HDM1002 50 mg

HDM1002 tablets, 50 mg once daily, 12 weeks

DRUG

HDM1002 100 mg

HDM1002 tablets, 100 mg once daily, 12 weeks

DRUG

HDM1002 200 mg

HDM1002 tablets, 200 mg once daily, 12 weeks

DRUG

HDM1002 400 mg

HDM1002 tablets, 400 mg once daily, 12 weeks

DRUG

HDM1002 200 mg BID

HDM1002 tablets, 200 mg twice daily, 12 weeks

DRUG

Placebo

Matching placebo will be provided

Sponsors & Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yiming Mu, Ph.D · Chinese PLA General Hospital

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
2024-06-27
Primary Completion
2025-05-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06481085 on ClinicalTrials.gov