To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
NCT ID: NCT06481085
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
324 participants
INTERVENTIONAL
2024-06-27
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
NCT07193459
A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin
NCT07109700
A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
NCT07082114
Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus
NCT06498284
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
NCT02077452
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HDM1002 50 mg
Participants received 50 mg HDM1002 administered orally once daily (QD)
HDM1002 50 mg
HDM1002 tablets, 50 mg once daily, 12 weeks
HDM1002 100 mg
Participants received maintenance dose of 100 mg with dose escalation starting from 50 mg HDM1002 administered orally once daily (QD)
HDM1002 100 mg
HDM1002 tablets, 100 mg once daily, 12 weeks
HDM1002 200 mg
Participants received maintenance dose 200 mg with dose escalation starting from 50 mg, 100 mg and then 200 mg HDM1002 administered orally QD
HDM1002 200 mg
HDM1002 tablets, 200 mg once daily, 12 weeks
HDM1002 400 mg
Participants received maintenance dose 200 mg with dose escalation starting from 50 mg, 100 mg, 200 mg and then 400 mg HDM1002 administered orally QD
HDM1002 400 mg
HDM1002 tablets, 400 mg once daily, 12 weeks
Placebo
Participants received matching placebo administered orally QD
Placebo
Matching placebo will be provided
HDM1002 200 mg bid
Participants received maintenance dose 400 mg with dose escalation starting from 25 mg, 50 mg, 100 mg and then 200 mg HDM1002 administered orally twice daily (BID)
HDM1002 200 mg BID
HDM1002 tablets, 200 mg twice daily, 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HDM1002 50 mg
HDM1002 tablets, 50 mg once daily, 12 weeks
HDM1002 100 mg
HDM1002 tablets, 100 mg once daily, 12 weeks
HDM1002 200 mg
HDM1002 tablets, 200 mg once daily, 12 weeks
HDM1002 400 mg
HDM1002 tablets, 400 mg once daily, 12 weeks
HDM1002 200 mg BID
HDM1002 tablets, 200 mg twice daily, 12 weeks
Placebo
Matching placebo will be provided
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months based on the World Health Organization (WHO 1999) and meets one of the following conditions:
* 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 6 weeks prior to screening; and must be stable for at least 12 weeks prior to randomization.
* Participants on diet and exercise alone for at least 12 weeks prior to screening will be limited to ≤20% of total participant population.
3. HbA1c ≥7.5% and ≤10.5% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤10.5% prior to randomization as assessed by the specified central laboratory.
4. Having a body mass index (BMI) of 22.5 to 40.0 kg/m2, inclusive.
5. Female participants of childbearing potential and male participants must agree to use highly effective contraception method from the day of signing the informed consent form (ICF) and until 30 days (female) or 90 days (male) after the final dose administration.
6. 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.
Exclusion Criteria
2. Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months before signing the ICF.
3. History of level 3 hypoglycemia (as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery) , or history of asymptomatic hypoglycaemic episodes within 6 months prior to signing the ICF.
4. Severe infection within 4 weeks prior to screening and may affect glucose control in the opinion of the investigator.
5. Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2).
6. Evidence of uncontrolled hypothyroidism or hyperthyroidism as judged by the investigator at the time of signing the ICF, or on a stable dose of medication therapy less than 3 months, or having been expected to require dose adjustments throughout the trial.
7. History of acute or chronic pancreatitis, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease within 6 months before signing the ICF.
8. Any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
9. Uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg under stable treatments of antihypertensive drugs at screening; or previous evidence of renal artery stenosis or unstable blood pressure (including postural hypotension).
10. Have had any of the following within 6 months before signing the ICF:
* unstable angina；
* heart failure (New York Heart Association, class III or IV);
* myocardial infarction (MI)；
* coronary artery bypass grafting or percutaneous coronary intervention；
* Uncontrolled severe arrhythmias (including: ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second to third degree atrioventricular block, sick sinus node syndrome, pre-excitation syndrome, etc.)；
* cerebrovascular accident (including stroke or transient ischemic attack).
11. Have a history of proliferative diabetic retinopathy and/or diabetic maculopathy, or evidence of other severe retinopathy that requires immediate treatment intervention.
12. Have a known history of liver disease, including: acute or chronic active liver disease (except non-alcoholic steatohepatitis) such as active hepatitis B, hepatitis C; or primary biliary cholangitis.
13. Have evidence of a significant, active autoimmune abnormality (for example, lupus or rheumatoid arthritis) that, in the opinion of the investigator, requires concurrent treatment with systemic glucocorticoids during the trial.
14. Evidence of any malignancy with 5 years before signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured).
15. Self-reported or documented change in body weight of ≥5% within 3 months before signing the ICF.
16. Having used a Glucagon-like peptide-1 (GLP-1) analogue within 6 months prior to signing the ICF; or previous discontinuation of a GLP-1 analogue due to safety/tolerability or lack of efficacy.
17. Estimated glomerular filtration rate (eGFR) \< 45 mL/min.
18. Positive result on HBsAg, anti-hepatitis C virus (HCV) antibodies, anti-immunodeficiency virus (HIV) antibodies, or a positive test result for antibodies to syphilis spirochetes.
19. History of alcohol abuse (i.e., drinking more than 14 standard units of alcohol per week for men and 7 standard units of alcohol per week for women, with 1 standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of spirits with alcohol content of 40% or 150 mL of wine) or drug addiction within one year before signing the ICF; or presence of a psychiatric disorder that, in the opinion of the investigator, could interfere with participation in the study (e.g., depression).
20. Pregnancy or lactation.
21. Known allergy to any components of the investigational drug, metformin or its excipients.
22. Have any of the following conditions: an investigator or sub-investigator, or a research assistant, or a pharmacist, or a study coordinator, or other staff member directly involved in the study, or any person who is dependent on the study site, the investigator, or the sponsor (such as employees or their immediate family member).
23. Enrolled in or participated in any other clinical study within 3 months (or within 5 times the elimination half-life, whichever is longer) prior to signing the ICF (except for subjects who signed written informed consent without any intervention of investigational product).
24. Any other condition considered by the investigator which is not suitable for participating in this study.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yiming Mu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing, , China
Peking University Shougang Hospital
Beijing, , China
Cangzhou Central Hospital
Cangzhou, , China
The Second Hospital of Jilin University
Changchun, , China
The Fourth Hospital of Changsha City
Changsha, , China
The Third Hospital of Changsha City
Changsha, , China
Chengdu Second People's Hospital
Chengdu, , China
The Affiliated Hospital of Chengdu University
Chengdu, , China
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, , China
The First Hospital of Handan City
Handan, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Huizhou Central People's Hospital
Huizhou, , China
Huzhou Central Hospital
Huzhou, , China
Jinan Central Hospital
Jinan, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
The Third People's Hospital of Luoyang City
Luoyang, , China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, , China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, , China
The First People's Hospital of Nanyang City
Nanyang, , China
Panjin Liaohe Oilfield General Hospital
Panjin, , China
The First Hospital of Qinhuangdao City
Qinhuangdao, , China
Suzhou Municipal Hospital
Suzhou, , China
The First Hospital of Shanxi Medical University
Taiyuan, , China
Tonghua Central Hospital
Tonghua, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
Xuzhou Cancer Hospital
Xuzhou, , China
Yueyang People's Hospital
Yueyang, , China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HDM1002-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.