Triple drug combination versus standard treatment in newly diagnosed type 2 diabetes
Tests semaglutide, empagliflozin and pioglitazone together in adults newly diagnosed with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: New Triple Therapy in Newly Diagnosed Type 2 Diabetes
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06946628, who can take part
Where in China
- the First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-sen University
- Trial code
- NCT06946628
- Record updated
- 27 April 2025
- Original description
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 objectives to achieve are:Read full original descriptionShow less
Combination Therapy With Semaglutide, Empagliflozin and Pioglitazone Versus Standard Therapy in Newly Diagnosed Type 2 Diabetes: a Multi-center Randomized Controlled Trial
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 objectives to achieve are:
1. To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM. 2. To compare the effects on β-cell function and glycemic control of the triple combination therapy against standard therapy in patients newly diagnosed with T2DM
Researchers will compare drug new triple combination therapy with semaglutide, empagliflozin, and pioglitazone to standard therapy (metformin-based treatment) to see if new triple combination therapy works better in achieving type 2 diabetes remission .
Participants will:
1. Take new triple combination therapy or a standard therapy every day for 6 months 2. Visit the clinic once every 0.5-1 month for checkups and tests 3. Keep a diary of their fingertip blood glucose and adverse events
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: 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; 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; 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; 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.