RecruitingPhase 3NCT07193459

Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise Only


Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

360 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new oral medication called HDM1002 for adults with Type 2 diabetes who are managing their blood sugar with diet and exercise alone (no diabetes drugs yet), to see if it safely lowers blood sugar levels. **You may be eligible if...** - You are between 18 and 75 years old with a confirmed Type 2 diabetes diagnosis of at least 10 weeks - You have been managing your diabetes with diet and exercise only (no blood sugar-lowering medication) for at least 10 weeks before signing consent - Your HbA1c (a 3-month blood sugar average) is between 7.5% and 10.5% - Your BMI is between 22.5 and 40.0 kg/m² - You agree to use highly effective contraception if applicable **You may NOT be eligible if...** - You are taking any blood sugar-lowering (hypoglycemic) medications - Your HbA1c is outside the 7.5–10.5% range - Your BMI is outside 22.5–40.0 kg/m² - You have been diagnosed with Type 2 diabetes for less than 10 weeks 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 200 mg

HDM1002 tablets, 200 mg once daily

DRUGHDM1002 400 mg

HDM1002 tablets, 400 mg once daily

DRUGPlacebo

Placebo tablets, once daily


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT07193459


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