Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Treatment
Group A (triple combination therapy group)
Group B (standard therapy group)
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, 18 years≤age≤75 years at the time of signing informed consent.
Newly diagnosed with type 2 diabetes, or diagnosed within 1 years according to theWHO diagnostic criteria.
Individuals who had not received previous antidiabetic therapy, or had not receivedantidiabetic therapy within 3 months prior to screening, or had not receivedantidiabetic therapy for more than 3 consecutive months or a combined total of morethan 3 months in the past 2 years.
6.5%≤HbA1c≤9.0% at screening confirmed by central laboratory analysis.
BMI≥24 kg/m2.
Exclusion
Exclusion Criteria:
Individuals with type 1 diabetes or special types of diabetes.
Allergy or intolerance to investigational drugs.
Estimated Glomerular Filtration Rate (eGFR) <20 mL/min/1.73 m².
Individuals with heart failure in New York Heart Association [NYHA] class III or IVin the 6 months prior to randomization.
History of bladder cancer or hematuria.
History of Multiple Endocrine Neoplasia Type 2 (MEN 2) or relevant family history.
History or family history of Medullary Thyroid Carcinoma (MTC), or susceptibility toMTC due to hereditary conditions.
History of fasting blood glucose≥13.9 mmol/L or the necessity for insulin use due tosevere infection, diabetic foot, etc.
History of acute diabetic complications: including diabetic ketoacidosis,hyperglycemic hyperosmolar state, lactic acidosis.
Severe diabetic microvascular complications: proliferative retinopathy, or urinaryAER>300mg/g, or urinary protein positive, quantitative >0.5g/24h.
Uncontrolled painful diabetic neuropathy and significant diabetic autonomicneuropathy.
Severe diabetic macrovascular complications: myocardial infarction, stroke orhospitalization for unstable angina and/or transient ischemic attack and/orperipheral arterial disease required for vascular intervention or amputation withinthe 12 months prior to screening.
Blood pressure persistently higher than 180/110 mmHg and not controllable to ≤160/100 mmHg within 1 week.
Alanine Aminotransferase (ALT) ≥2.5 times the upper normal limit, total bilirubin ≥1.5 times the upper normal limit.
Hemoglobin <100g/L or requiring regular blood transfusion.
Use of medicines potentially affecting blood glucose for more than 1 weekcumulatively in the past 12 weeks, such as corticosteroids, growth hormone analogs,estrogen/progestogen, high-dose diuretics, antipsychotic drugs, etc.
Participation in another trial involving medicine therapy within the past 3 months.
Expected lifespan less than 2 years as per the investigator's clinical judgment,e.g., but not limited to malignancy.
Pregnant or lactating females, or females of childbearing potential who cannot orare unwilling to use adequate contraception.
Deemed unsuitable for participation in this clinical trial at the discretion of theinvestigator.
Study Design
Connect with a study center
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available

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