Type 2 DiabetesPhase 3NCT07193459
Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
A Phase 3 study testing HDM1002 200 mg and HDM1002 400 mg in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 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 200 mg and HDM1002 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2025to 1 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 10 weeks based on the World Health Organization, and meet the following conditions:a) had been treated with diet and exercise for at least 10 weeks prior to signing ICF; b) Not been treated with any hypoglycemic drugs within 10 weeks prior to signing ICF.
- 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 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 prior to signing ICF.
- Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2)
- History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator)
- Have had dysphagia, or any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of surgery affecting gastric emptying, gastroesophageal reflux disease, pyloric obstruction, irritable bowel syndrome, etc.
- Have had any of the following within 3 months prior to screening:
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- 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
- Have a history of proliferative diabetic retinopathy and/or diabetic maculopathy that requires treatment, or evidence of other severe retinopathy that requires treatment during the study.
- 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.
- Those who have used the following drugs within 14 days before randomization or within 5 half-lives (whichever is longer), or who need to use the following drugs for a long time during the trial, are excluded: strong or moderate inhibitors of cytochrome P450 enzyme (CYP) 3A4, strong inducers of CYP3A4, strong inhibitors of P-gp, strong inducers of P-gp, inhibitors of OATP1B1 or OATP1B3, or narrow therapeutic index drugs that are CYP2C8, CYP3A4, UGT1A1, P-gp, OATP1B1 or OATP1B3 substrates.
- Use of any glucose-lowering medication within 10 weeks prior to signing ICF, including but not limited to: α-glucosidase inhibitors (e.g., acarbose), thiazolidinediones, and dipeptidyl peptidase-4 inhibitors (DPP-4i) inhibitors, glucose kinase activators, sodium-glucose cotransporter-2 inhibitors (SGLT-2i) ,with the exception of short-term insulin therapy due to a concomitant illness, stress, or perioperative period (cumulative duration ≤ 14 days).
- Having used a Glucagon-like peptide-1 (GLP-1) analogue within 3 months prior to signing the ICF; or previous discontinuation of a GLP-1 analogue due to safety/tolerability or lack of efficacy.
- Pregnancy or lactation.
- Subjects with a known hypersensitivity to GLP-1 receptor agonists (GLP-1RA), or a history of severe drug allergies.
- Enrolled in or participated in any other clinical study of drugs or medical devices within 3 months (or within 5 half-lives, whichever is longer) prior to signing the ICF (except for subjects who signed written informed consent without any intervention of investigational product or medical devices).
- Any other condition considered by the investigator which is not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Linong Ji, 010-88325578, jiln@bjmu.edu.cn
About this study
Official title: 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
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
Read the detailed description
This phase 3, 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 with diet and exercise only. A total of 360 participants will be randomized in this study, and will be stratified according to baseline glycated hemoglobin (HbA1c) (≤ 8.5% or > 8.5%). Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a 2-week placebo run-in period prior to randomization on Day 1. Eligible participants will be randomized in a 1:1:1 ratio to receive different doses of HDM1002 or placebo once daily for 52 weeks, followed by an approximate 4-week follow-up. During the treatment period, dose escalation will occur every 4 weeks until the target dose is reached. The evaluation of the primary endpoint will be conducted at Week 40
- Conditions
- Type 2 Diabetes
- Being tested
- HDM1002 200 mg, HDM1002 400 mg, Placebo
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, HDM1002 tablet, type 2 diabetes
- 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 200 mgDrug
HDM1002 tablets, 200 mg once daily
HDM1002 400 mgDrug
HDM1002 tablets, 400 mg once daily
PlaceboDrug
Placebo tablets, once daily
| Study group | Role | What they receive |
|---|---|---|
| HDM1002 200mg | Experimental | Participants 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 400mg | Experimental | Participants received maintenance dose 400 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 |
| Placebo | Placebo comparator | Participants received placebo orally QD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c at Week 40
Measured: Week 40
Secondary outcomes (12)
Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia
Measured: Week 40
Change from baseline in body weight, body mass index (BMI), and waist circumference
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Measured: Weeks 40
Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%
Measured: Weeks 40
Change From Baseline in Fasting plasma Glucose, fasting C-peptide and fasting insulin
The fasting plasma glucose measures the levels of glucose in the blood, with a normal range of 70 mg/dL to 99 mg/dL;C-Peptide and Fasting Insulin were measured at planned time points
Measured: Weeks 40
Change from baseline in daily average levels of 7-point self-monitored blood glucose (SMBG) and mean postprandial glucose increment (all meals)
Measured: Weeks 40
Change From Baseline in Postprandial 2-hour Glucose, C-Peptide, Insulin
These indicators were assessed using the mixed-meal tolerance test
Measured: Weeks 40
Change from baseline in homeostasis model assessment of β-cell function (HOMA-β) and insulin resistance (HOMA-IR)
HOMA-IR and HOMA-β are commonly used to estimate insulin resistance and beta cell function
Measured: Weeks 40
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)]
Measured: Weeks 40
Change From Baseline in Systolic and Diastolic Blood Pressure
Measured: Weeks 40
Change from baseline in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) score
Measured: Weeks 40
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.
Measured: through study completion, an average of 1 year
Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination, Electrocardiogram and clinical laboratory evaluations
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start12 Aug 2025
- Primary completion10 Oct 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193459
- Sponsor's protocol ID
- HDM1002-302
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07193459
- Acronym / sponsor ID
- HDM1002-302
- Conditions
- Type 2 Diabetes
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, HDM1002 tablet, type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This phase 3, 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 with diet and exercise only. A total of 360 participants will be randomized in this study, and will be stratified according to baseline glycated hemoglobin (HbA1c) (≤ 8.5% or > 8.5%). Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a 2-week placebo run-in period prior to randomization on Day 1. Eligible participants will be randomized in a 1:1:1 ratio to receive different doses of HDM1002 or placebo once daily for 52 weeks, followed by an approximate 4-week follow-up. During the treatment period, dose escalation will occur every 4 weeks until the target dose is reached. The evaluation of the primary endpoint will be conducted at Week 40
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HDM1002 200mg | Experimental | Drug: HDM1002 200 mgParticipants received maintenance dose 200 mg with dose escalation starting from 50 mg, 100 mg and then 200 mg HDM1002 administered orally QD |
| HDM1002 400mg | Experimental | Drug: HDM1002 400 mgParticipants received maintenance dose 400 mg with dose escalation starting from 50 mg, 100 mg, 200 mg and then 400 mg HDM1002 administered orally QD |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo orally QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects between 18 and 75 years of age (inclusive).
- Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 10 weeks based on the World Health Organization, and meet the following conditions:a) had been treated with diet and exercise for at least 10 weeks prior to signing ICF; b) Not been treated with any hypoglycemic drugs within 10 weeks prior to signing ICF.
- 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 ICF and until 30 days (female) or 90 days (male) after the final dose administration.
Key exclusion criteria (21 listed)
- 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 prior to signing ICF.
- Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2)
- History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator)
- Have had dysphagia, or any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of surgery affecting gastric emptying, gastroesophageal reflux disease, pyloric obstruction, irritable bowel syndrome, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDM1002 200 mgHDM1002 tablets, 200 mg once daily | Drug | HDM1002 200mg |
| HDM1002 400 mgHDM1002 tablets, 400 mg once daily | Drug | HDM1002 400mg |
| PlaceboPlacebo tablets, once daily | Drug | Placebo |
Primary outcome
Change From Baseline in HbA1c at Week 40
Time frame: Week 40
12 secondary outcomes
Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia
Time frame: Week 40
Change from baseline in body weight, body mass index (BMI), and waist circumference
Time frame: Weeks 40
Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%
Time frame: Weeks 40
Change From Baseline in Fasting plasma Glucose, fasting C-peptide and fasting insulin
Time frame: Weeks 40
Change from baseline in daily average levels of 7-point self-monitored blood glucose (SMBG) and mean postprandial glucose increment (all meals)
Time frame: Weeks 40
Change From Baseline in Postprandial 2-hour Glucose, C-Peptide, Insulin
Time frame: Weeks 40
Change from baseline in homeostasis model assessment of β-cell function (HOMA-β) and insulin resistance (HOMA-IR)
Time frame: Weeks 40
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)]
Time frame: Weeks 40
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: Weeks 40
Change from baseline in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) score
Time frame: Weeks 40
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.
Time frame: through study completion, an average of 1 year
Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination, Electrocardiogram and clinical laboratory evaluations
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDM1002 200 mg and HDM1002 400 mg in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site 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 6 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in HbA1c at Week 40 (time frame: Week 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2025.