New Triple Combination Therapy in Newly Diagnosed Type 2 Diabetes

Korábbi kezelés

• Allergy or intolerance to investigational drugs.
• Individuals with heart failure in New York Heart Association [NYHA] class III or IV in the 6 months prior to randomization.
• Severe diabetic macrovascular complications: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack and/or peripheral arterial disease required for vascular intervention or amputation within the 12 months prior to screening.
• Participation in another trial involving medicine therapy within the past 3 months.

Más betegség

• Individuals with type 1 diabetes or special types of diabetes.
• 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 to MTC due to hereditary conditions.
• History of acute diabetic complications: including diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis.
• Expected lifespan less than 2 years as per the investigator's clinical judgment, e.g., but not limited to malignancy.

Laborértékek

• Estimated Glomerular Filtration Rate (eGFR) <20 mL/min/1.73 m².
• History of fasting blood glucose≥13.9 mmol/L or the necessity for insulin use due to severe infection, diabetic foot, etc.
• 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 week cumulatively in the past 12 weeks, such as corticosteroids, growth hormone analogs, estrogen/progestogen, high-dose diuretics, antipsychotic drugs, etc.

Egyéb

• Severe diabetic microvascular complications: proliferative retinopathy, or urinary AER>300mg/g, or urinary protein positive, quantitative >0.5g/24h.
• Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy.
• Blood pressure persistently higher than 180/110 mmHg and not controllable to ≤160/100 mmHg within 1 week.
• Pregnant or lactating females, or females of childbearing potential who cannot or are unwilling to use adequate contraception.
• Deemed unsuitable for participation in this clinical trial at the discretion of the investigator.

• 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 the WHO diagnostic criteria.
• Individuals who had not received previous antidiabetic therapy, or had not received antidiabetic therapy within 3 months prior to screening, or had not received antidiabetic therapy for more than 3 consecutive months or a combined total of more than 3 months in the past 2 years.
• 6.5%≤HbA1c≤9.0% at screening confirmed by central laboratory analysis.
• BMI≥24 kg/m2.