← Trials/Trial dossier/NCT06946628

Not yet recruitingPhase 3

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

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 ≥24HbA1c ≤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

NCT IDNCT06946628
Org study IDNew Triple-2025

Timeline

Milestones

Study first posted2025-04-27actual
Last update posted2025-04-27actual
Study start2025-06-01estimated
Primary completion2028-12-31estimated
Study completion2030-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
10
Other (unclassified)
3
Weight & body composition
1
Patient-reported / QoL
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight 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 endpoints
Primary/protocol endpoint

Diabetic remission rate

Time frame:6 months after discontinuation of medication

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Diabetic remission rate

Time frame:3 and 12 months after discontinuation of medication

threshold achievement, improvement

Secondary/protocol endpoint

Time required to achieve glycemic goal

Time frame:6 months of medication

time to event, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Blood insulin level

Time frame:baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication

descriptive

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

EQ-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 endpoints
Secondary/protocol endpoint/low confidence

Incremental cost per additional remission

Time frame:6 months after discontinuation of medication

descriptive

Secondary/protocol endpoint/low confidence

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

Secondary/protocol endpoint/low confidence

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.