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RecruitingPhase 3

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

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

800

estimated

Study population

Type 2 diabetes

Key I/E criteria

BMI 19-40HbA1c 7.5-11%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07082114
Org study IDHDM1002-303

Timeline

Milestones

Study start2025-07-14actual
Study first posted2025-07-24actual
Last update posted2025-07-24actual
Primary completion2027-02-16estimated
Study completion2027-05-17estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female subjects between 18 and 75 years of age (inclusive).

2. Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months based on the World Health Organization, and 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 8 weeks prior to screening; and must be stable for at least 12 weeks prior to randomization.

3. HbA1c ≥7.5% and ≤11.0% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤11.0% prior to randomization as assessed by the specified central laboratory.

4. Having a body mass index (BMI) of 19.0 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 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

1. Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus

2. Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months prior to signing the informed consent form (ICF).

3. Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2)

4. 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)

5. 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.

6. Have had any of the following within 3 months prior to screening:

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

7. 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.

8. 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.

9. Used strong CYP3A4 or P-gp inhibitors within 14 days prior to randomization or 5 half-lives (whichever is longer); current use with strong/moderate CYP3A4 inhibitors or strong P-gp inducers that cannot be discontinued during the trial; any prior use OATP1B1/OATP1B3 inhibitors; current use with narrow therapeutic index drugs that are substrates of CYP2C8, CYP3A4, UGT1A1, P-gp, or OATP1B1/OATP1B3 and cannot be discontinued during the trial.

10. Use of any glucose-lowering medication within 4 weeks prior to signing the 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 ≤ 7 days).

11. 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.

12. Pregnancy or lactation.

13. Subjects with a known hypersensitivity to SGLT-2i or GLP-1 receptor agonists (GLP-1RA), or a history of severe drug allergies.

14. 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).

15. Any other condition considered by the investigator which is not suitable for participating in this study.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Weight & body composition
3
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2
Patient-reported / QoL
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Change from baseline in body weight, body mass index (BMI), and waist circumference

Time frame:Baseline, Weeks 40, Week 52

change from baseline, improvement

componentsBody weight, absolute change (kg), BMI, change, Waist circumference, change

Secondary/protocol endpoint

Percentage change from baseline in body weight

Time frame:Baseline, Weeks 40, Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Weeks 40, Week 52

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Change From Baseline in HbA1c at Week 40

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in HbA1c at Week 52

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% with or without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia

Time frame:Baseline, Week 40, Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting plasma Glucose

Time frame:Baseline, Weeks 40, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in fasting C-peptide and fasting insulin

Time frame:Baseline, Weeks 40, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in homeostasis model assessment of β-cell function (HOMA-β) and insulin resistance (HOMA-IR)

Time frame:Baseline, Weeks 40, Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, Weeks 40, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in daily average levels of 7-point self-monitored blood glucose (SMBG) and mean postprandial glucose increment (all meals)

Time frame:Baseline, Weeks 40, Week 52

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

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:Baseline, Weeks 40, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic and Diastolic Blood Pressure

Time frame:Baseline, Weeks 40, Week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change from baseline in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) score

Time frame:Baseline, Weeks 40, Week 52

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

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:Baseline through Week 56

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Documented hypoglycemia

Secondary/protocol endpoint

Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination, Electrocardiogram and clinical laboratory evaluations

Time frame:Baseline through Week 56

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.