RecruitingPhase 3NCT07082114

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

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


Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

800 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing a new oral tablet called HDM1002 as an add-on treatment for adults with Type 2 diabetes whose blood sugar is not well controlled on metformin alone. The goal is to see if HDM1002 can help lower blood sugar levels (HbA1c) safely and effectively. **You may be eligible if...** - You are between 18 and 75 years old with Type 2 diabetes diagnosed at least 3 months ago - You have been taking a stable dose of metformin (at least 1500 mg per day or the maximum tolerated dose) for at least 8 weeks - Your HbA1c (a 3-month blood sugar average) is between 7.5% and 11% - Your BMI is between 19 and 40 **You may NOT be eligible if...** - You have Type 1 diabetes or any form other than Type 2 - You have had a recent serious heart event, stroke, or uncontrolled heart failure within the past 3 months - You have a history of pancreatitis, thyroid cancer, or severe digestive problems - You are pregnant, breastfeeding, or have taken a GLP-1 drug (such as semaglutide) in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHDM1002 100 mg

HDM1002 tablets, 100 mg once daily, 52 weeks

DRUGHDM1002 200 mg

HDM1002 tablets, 200 mg once daily, 52 weeks

DRUGHDM1002 400 mg

HDM1002 tablets, 400 mg once daily, 52 weeks

DRUGDapagliflozin (DAPA)

dapagliflozin 10mg will be provided


Locations(1)

Yueyang People's Hospital

Yueyang, Hunan, China

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NCT07082114


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