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New Triple Therapy in Newly Diagnosed Type 2 Diabetes
Combination Therapy With Semaglutide, Empagliflozin and Pioglitazone Versus Standard Therapy in Newly Diagnosed Type 2 Diabetes: a Multi-center Randomized Controlled Trial
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
296
estimated
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥24•HbA1c ≤9%
Primary endpoint
•HbA1c <6.5% achievement
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, 18 years≤age≤75 years at the time of signing informed consent.
2. Newly diagnosed with type 2 diabetes, or diagnosed within 1 years according to the WHO diagnostic criteria.
3. 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.
4. 6.5%≤HbA1c≤9.0% at screening confirmed by central laboratory analysis.
5. BMI≥24 kg/m2.
Exclusion criteria
1. Individuals with type 1 diabetes or special types of diabetes.
2. Allergy or intolerance to investigational drugs.
3. Estimated Glomerular Filtration Rate (eGFR) <20 mL/min/1.73 m².
4. Individuals with heart failure in New York Heart Association [NYHA] class III or IV in the 6 months prior to randomization.
5. History of bladder cancer or hematuria.
6. History of Multiple Endocrine Neoplasia Type 2 (MEN 2) or relevant family history.
7. History or family history of Medullary Thyroid Carcinoma (MTC), or susceptibility to MTC due to hereditary conditions.
8. History of fasting blood glucose≥13.9 mmol/L or the necessity for insulin use due to severe infection, diabetic foot, etc.
9. History of acute diabetic complications: including diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis.
10. Severe diabetic microvascular complications: proliferative retinopathy, or urinary AER>300mg/g, or urinary protein positive, quantitative >0.5g/24h.
11. Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy.
12. 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.
13. Blood pressure persistently higher than 180/110 mmHg and not controllable to ≤160/100 mmHg within 1 week.
14. Alanine Aminotransferase (ALT) ≥2.5 times the upper normal limit, total bilirubin ≥1.5 times the upper normal limit.
15. Hemoglobin <100g/L or requiring regular blood transfusion.
16. 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.
17. Participation in another trial involving medicine therapy within the past 3 months.
18. Expected lifespan less than 2 years as per the investigator's clinical judgment, e.g., but not limited to malignancy.
19. Pregnant or lactating females, or females of childbearing potential who cannot or are unwilling to use adequate contraception.
20. Deemed unsuitable for participation in this clinical trial at the discretion of the investigator.
Endpoints (15)
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
1 endpointWeight changes
Time frame:baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
10 endpointsDiabetic remission rate
Time frame:6 months after discontinuation of medication
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Diabetic remission rate
Time frame:3 and 12 months after discontinuation of medication
threshold achievement, improvement
Time required to achieve glycemic goal
Time frame:6 months of medication
time to event, improvement
HbA1c
Time frame:baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Blood glucose level
Time frame:baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Blood insulin level
Time frame:baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
descriptive
Blood C-peptide level
Time frame:baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
C-peptide AUC
descriptive
Pancreatic β-cell function
Time frame:baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
change from baseline, improvement
Insulin resistance
Time frame:baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Time in range (TIR)
Time frame:At baseline, at 6 months of medication treatment, and at 6 months after discontinuation of medication
CGM time-in-range
descriptive, improvement
Patient-reported / QoL
1 endpointEQ-5D-5L questionnaires, quality of life
Time frame:At baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
EQ-5D index
descriptive, improvement
Other (unclassified)
3 endpointsIncremental cost per additional remission
Time frame:6 months after discontinuation of medication
descriptive
Incremental cost per additional improvement in Time in Range (TIR)
Time frame:6 months of medication treatment, and at 6 months after discontinuation of medication
descriptive
Incremental cost per QALY gained
Time frame:at baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
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.