← Trials/Trial dossier/NCT07082114
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 19-40•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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:
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
Weight & body composition
3 endpointsChange 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
Percentage change from baseline in body weight
Time frame:Baseline, Weeks 40, Week 52
Body weight, % change
percent change from baseline, improvement
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 endpointsChange From Baseline in HbA1c at Week 40
Time frame:Baseline, Week 40
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change From Baseline in HbA1c at Week 52
Time frame:Baseline, Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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
Change From Baseline in Fasting plasma Glucose
Time frame:Baseline, Weeks 40, Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change from baseline in fasting C-peptide and fasting insulin
Time frame:Baseline, Weeks 40, Week 52
change from baseline, improvement
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
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
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 endpointsChange 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
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 endpointChange 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 endpointsNumber 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
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 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.