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To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
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
Asset
HDM1002
Oral · GLP-1 agonist
Listed sites
31
Recruiting sites
—
Enrollment
324
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI 22.5-40•HbA1c 7.5-10.5%
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 (WHO 1999) and meets one of the following conditions:
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
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 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:
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.
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
Time frame:Baseline, Week 12
Body weight, absolute change (kg)
change from baseline, improvement
Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%
Time frame:Baseline, Week 12
≥10% weight-loss responders
threshold achievement, improvement
components≥5% weight-loss responders, ≥10% weight-loss responders
Change From Baseline in Body Weight According to Treatment Background ( Metformin or Diet and Exercise Alone)
Time frame:Baseline, Week 12
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
8 endpointsChange From Baseline in HbA1c at Week 12
Time frame:Baseline, Week 12
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change From Baseline in HbA1c at Week 4, Week 8
Time frame:Baseline, Week 4, Week 8
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5%
Time frame:Baseline, Week 12
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Change From Baseline in Fasting plasma Glucose
Time frame:Baseline, Week 12
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
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)
Time frame:Baseline, Week 12
change from baseline, improvement
componentsPostprandial glucose, C-peptide AUC
Change From Baseline in Fasting C-Peptide, Fasting Insulin, and Fasting Glucagon
Time frame:Baseline, Week 12
change from baseline, improvement
componentsC-peptide AUC, HOMA-IR (insulin sensitivity), Postprandial glucose
Change From Baseline in Homeostasis Model Assessment of β-Cell Function (HOMA-β) and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:Baseline, Week 12
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Change From Baseline in Glycaemic Indicators According to Treatment Background ( Metformin or Diet and Exercise Alone)
Time frame:Baseline, Week 12
change from baseline, improvement
componentsHbA1c, change, Fasting glucose, change, Postprandial glucose
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, Week 12
change from baseline, improvement
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame:Baseline, Week 12
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Safety / tolerability / PK
3 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 16
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 and Electrocardiogram
Time frame:Baseline Through Week 16
descriptive
Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)
Time frame:Baseline, Day 71
concentration, 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.