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Type 2 DiabetesPhase 2NCT06481085

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

A Phase 2 study testing HDM1002 50 mg, HDM1002 100 mg and HDM1002 200 mg in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 31 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
HDM1002 50 mg, HDM1002 100 mg and HDM1002 200 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
324 participants
Where
31 sitesChina
Study dates
27 Jun 2024to 30 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects between 18 and 75 years of age (inclusive).
  • 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.
  • 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.
  • Having a body mass index (BMI) of 22.5 to 40.0 kg/m2, inclusive.
  • 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.
  • 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.

Who cannot join

  • Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus.
  • Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months before signing the ICF.
  • 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.
  • Severe infection within 4 weeks prior to screening and may affect glucose control in the opinion of the investigator.
  • Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2).
  • 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.
Show all 30Show fewer
  • 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.
  • 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.
  • 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).
  • 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).
  • Have a history of proliferative diabetic retinopathy and/or diabetic maculopathy, or evidence of other severe retinopathy that requires immediate treatment intervention.
  • 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.
  • 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.
  • 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).
  • Self-reported or documented change in body weight of ≥5% within 3 months before signing the ICF.
  • 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.
  • Estimated glomerular filtration rate (eGFR) < 45 mL/min.
  • 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.
  • 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).
  • Pregnancy or lactation.
  • Known allergy to any components of the investigational drug, metformin or its excipients.
  • 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).
  • 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).
  • Any other condition considered by the investigator which is not suitable for participating in this study.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • The Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality, 100039

  • Beijing Chaoyang Hospital Affiliated to Capital Medical University

    Beijing

  • Peking University Shougang Hospital

    Beijing

  • Cangzhou Central Hospital

    Cangzhou

  • The Second Hospital of Jilin University

    Changchun

  • The Fourth Hospital of Changsha City

    Changsha

  • The Third Hospital of Changsha City

    Changsha

  • Chengdu Second People's Hospital

    Chengdu

  • The Affiliated Hospital of Chengdu University

    Chengdu

  • Three Gorges Hospital Affiliated to Chongqing University

    Chongqing

  • The First Hospital of Handan City

    Handan

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

  • Huizhou Central People's Hospital

    Huizhou

  • Huzhou Central Hospital

    Huzhou

  • Jinan Central Hospital

    Jinan

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

  • The Third People's Hospital of Luoyang City

    Luoyang

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang

  • The First People's Hospital of Nanyang City

    Nanyang

  • Panjin Liaohe Oilfield General Hospital

    Panjin

  • The First Hospital of Qinhuangdao City

    Qinhuangdao

  • Suzhou Municipal Hospital

    Suzhou

  • The First Hospital of Shanxi Medical University

    Taiyuan

  • Tonghua Central Hospital

    Tonghua

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Xuzhou Cancer Hospital

    Xuzhou

  • Yueyang People's Hospital

    Yueyang

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: A Phase 2, 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 on Metformin or Diet and Exercise

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.

Read the detailed description

This phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel group study aims to assess the efficacy and safety of HDM1002 tablets in adult participants with T2DM inadequately controlled on metformin monotherapy or diet and exercise alone. At least 80% of the enrolled participants are required to be on metformin prior to screening. A total of 318 participants will be included in this study, and will be stratified according to baseline glycated hemoglobin (HbA1c) (≤ 8.5% or > 8.5%) and background diabetes treatment (metformin or diet and exercise alone). For cohort A to cohort E, approximately 293 participants will be randomized in a 57:57:57:65:57 ratio to receive different doses of HDM1002 or placebo. In addition, an open-label design will be used in cohort F to explore the efficacy and safety of HDM1002 tablets administered in 200 mg twice daily. About 25 participants will be enrolled in cohort F, all of which will receive HDM1002 tablets. Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a 2-week placebo run-in period (participants with diet and exercise alone) or a 6-week metformin run-in period (participants with metformin prior to screening) prior to randomization on Day 1. The treatment period will be 12 weeks, followed by an approximate 4-week follow-up. Dosing will occur with or without food once daily or twice daily, and up to 4 weeks of dose titration regimen will be adopted to maximize tolerability of HDM1002.

Conditions
Type 2 Diabetes
Being tested
HDM1002 50 mg, HDM1002 100 mg, HDM1002 200 mg, HDM1002 400 mg, HDM1002 200 mg BID
Keywords
HDM1002 tablet, type 2 diabetes, Glucagon-Like Peptide-1 Receptor Agonists
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDM1002 50 mgDrug

    Also called HDM1002

    HDM1002 tablets, 50 mg once daily, 12 weeks

  • HDM1002 100 mgDrug

    Also called HDM1002

    HDM1002 tablets, 100 mg once daily, 12 weeks

  • HDM1002 200 mgDrug

    Also called HDM1002

    HDM1002 tablets, 200 mg once daily, 12 weeks

  • HDM1002 400 mgDrug

    Also called HDM1002

    HDM1002 tablets, 400 mg once daily, 12 weeks

  • HDM1002 200 mg BIDDrug

    Also called HDM1002

    HDM1002 tablets, 200 mg twice daily, 12 weeks

  • PlaceboDrug

    Also called Matching placebo for group A to group E

    Matching placebo will be provided

Study groups in NCT06481085
Study groupRoleWhat they receive
HDM1002 50 mgExperimentalParticipants received 50 mg HDM1002 administered orally once daily (QD)
Receives: Drug: HDM1002 50 mg
HDM1002 100 mgExperimentalParticipants received maintenance dose of 100 mg with dose escalation starting from 50 mg HDM1002 administered orally once daily (QD)
Receives: Drug: HDM1002 100 mg
HDM1002 200 mgExperimentalParticipants received maintenance dose 200 mg with dose escalation starting from 50 mg, 100 mg and then 200 mg HDM1002 administered orally QD
Receives: Drug: HDM1002 200 mg
HDM1002 400 mgExperimentalParticipants received maintenance dose 200 mg with dose escalation starting from 50 mg, 100 mg, 200 mg and then 400 mg HDM1002 administered orally QD
Receives: Drug: HDM1002 400 mg
PlaceboPlacebo comparatorParticipants received matching placebo administered orally QD
Receives: Drug: Placebo
HDM1002 200 mg bidExperimentalParticipants 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)
Receives: Drug: HDM1002 200 mg BID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HbA1c at Week 12

    HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control

    Measured: Baseline, Week 12

Secondary outcomes (12)

  1. Change From Baseline in HbA1c at Week 4, Week 8

    HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control

    Measured: Baseline, Week 4, Week 8

  2. Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5%

    The target HbA1c level for people with diabetes is usually less than 7%.

    Measured: Baseline, Week 12

  3. Change From Baseline in Fasting plasma Glucose

    The fasting plasma glucose measures the levels of glucose in the blood, with a normal range of 70 mg/dL to 99 mg/dL.

    Measured: Baseline, Week 12

  4. Change From Baseline in Postprandial 2-hour Glucose (PPG2h), Area Under the Curve of Plasma Glucose (AUC0-4h, Glucose), C-Peptide (AUC0-4h, C-peptide), Insulin (AUC0-4h, Insulin), and Glucagon (AUC0-4h, Glucagon)

    These indicators were assessed using the mixed-meal tolerance test

    Measured: Baseline, Week 12

  5. Change From Baseline in Fasting C-Peptide, Fasting Insulin, and Fasting Glucagon

    C-Peptide, Fasting Insulin, and Fasting Glucagon were measured at planned time points

    Measured: Baseline, Week 12

  6. Change From Baseline in Homeostasis Model Assessment of β-Cell Function (HOMA-β) and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    HOMA-IR and HOMA-β are commonly used to estimate insulin resistance and beta cell function.

    Measured: Baseline, Week 12

  7. Change From Baseline in Fasting Lipid Profiles, including: Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Total Cholesterol (TC), Non-HDL-C and Lipoprotein (a) [Lp(a)]

    Fasting Lipid Profiles were measured at planned time points.

    Measured: Baseline, Week 12

  8. Change From Baseline in Systolic and Diastolic Blood Pressure

    Blood Pressure was measured using an automated device

    Measured: Baseline, Week 12

  9. Change From Baseline in Body Weight

    Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.

    Measured: Baseline, Week 12

  10. Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%

    Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.

    Measured: Baseline, Week 12

  11. Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]), Adverse Events of Special Interest (AESI), Incidence and Severity of Hypoglycaemic Events, etc.

    A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.

    Measured: Baseline Through Week 16

  12. Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination and Electrocardiogram

    Vital signs (blood pressure, pulse rate, body temperature, respiratory rate), physical examination, ECG and clinical laboratory evaluations (hematology, clinical chemistry, coagulation, urinalysis, calcitonin, serum amylase and lipase)

    Measured: Baseline Through Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start27 Jun 2024
  3. Primary completion30 May 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481085
Sponsor's protocol ID
HDM1002-202
Status last verified
Jul 2025
First submitted
13 Jun 2024
Last updated
28 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HDM1002 50 mg, HDM1002 100 mg and HDM1002 200 mg in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06481085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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