Status:
NOT_YET_RECRUITING
New Triple Therapy in Newly Diagnosed Type 2 Diabetes
Lead Sponsor:
Sun Yat-sen University
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to learn the efficany of combination therapy with semaglutide, empagliflozin and pioglitazone versus standard therapy in newly diagnosed type 2 diabetes. The main ob...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 IV in 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 to MTC due to hereditary conditions.
- History of fasting blood glucose≥13.9 mmol/L or the necessity for insulin use due to severe infection, diabetic foot, etc.
- History of acute diabetic complications: including diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis.
- 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.
- 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.
- 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 week cumulatively 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 or are unwilling to use adequate contraception.
- Deemed unsuitable for participation in this clinical trial at the discretion of the investigator.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT06946628
Start Date
June 1 2025
End Date
December 31 2030
Last Update
April 27 2025
Active Locations (1)
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1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080