Diabetes MellitusPhase 3NCT06946628
New Triple Therapy in Newly Diagnosed Type 2 Diabetes
A Phase 3 study testing Group A (triple combination therapy group) and Group B (standard therapy group) in people with Diabetes Mellitus, run by Sun Yat-sen University at 1 site in China.
Trial 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 objectives to achieve are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Group A (triple combination therapy group) and Group B (standard therapy group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Hai Li, MD, PHD, +86-15920362668, lihai8@mail.sysu.edu.cn
About this study
Official title: 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:
- To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM.
- 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
Read more
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:
- Take new triple combination therapy or a standard therapy every day for 6 months
- Visit the clinic once every 0.5-1 month for checkups and tests
- Keep a diary of their fingertip blood glucose and adverse events
- Conditions
- Diabetes Mellitus
- Being tested
- Group A (triple combination therapy group), Group B (standard therapy group)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (triple combination therapy group)Drug
- Initiate with Semaglutide 0.25 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, if blood glucose is not controlled, adjust to Semaglutide 0.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd. If Semaglutide is well-tolerated, increase to 1 mg qw after 1 week; 3)If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.
Group B (standard therapy group)Drug
metformin-based treatment is recommended when not contraindicated. 1).Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After another month, if blood glucose remains uncontrolled, add Semaglutide 0.25 mg qw, then increase to 0.5 mg qw after 1 month. If well-tolerated, increase to 1.0 mg qw after 1 week; 4) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group A (triple combination therapy group) | Experimental | semaglutide, empagliflozin, and pioglitazone treatment. 1) Initiate with Semaglutide 0.25 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, if blood glucose is not controlled, adjust to Semaglutide 0.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd. If Semaglutide is well-tolerated, increase to 1 mg qw after 1 week; 3)If blood glucose remains uncontrolled after 1 month, add basal insulin therapy. Receives: Drug: Group A (triple combination therapy group) |
| Group B (standard therapy group) | Active comparator | metformin-based treatment is recommended when not contraindicated. 1).Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After another month, if blood glucose remains uncontrolled, add Semaglutide 0.25 mg qw, then increase to 0.5 mg qw after 1 month. If well-tolerated, increase to 1.0 mg qw after 1 week; 4) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy. Receives: Drug: Group B (standard therapy group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic remission rate
Diabetic remission rate at 6 months after discontinuation of medication (percentage of patients with HbA1c <6.5% at 6 months after discontinuation of medication)
Measured: 6 months after discontinuation of medication
Secondary outcomes (14)
Diabetic remission rate
Diabetic remission rate at 3 and 12 months after discontinuation of medication and the time of diabetic remission
Measured: 3 and 12 months after discontinuation of medication
Time required to achieve glycemic goal
The time required to achieve glycemic goal(FBG <6.1mmol/L, 2h PPG <8.0mmol/L or HbA1c<6.5%)
Measured: 6 months of medication
EQ-5D-5L questionnaires, quality of life
EQ-5D-5L questionnaires, assessment of quality of life. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: At baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
Incremental cost per additional remission
Incremental cost per additional remission at 6 months after discontinuation of medication
Measured: 6 months after discontinuation of medication
HbA1c
HbA1c level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Measured: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood glucose level
Fasting and 2-hour postprandial blood glucose level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Measured: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood insulin level
Fasting and 2-hour postprandial insulin level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Measured: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood C-peptide level
Fasting and 2-hour postprandial C-peptide level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Measured: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Pancreatic β-cell function
HOMA-B at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Measured: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Insulin resistance
HOMA-IR at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Measured: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Weight changes
Weight at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Measured: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Time in range (TIR)
Time within the target blood glucose range (3.9-10.0 mmol/L)
Measured: At baseline, at 6 months of medication treatment, and at 6 months after discontinuation of medication
Incremental cost per additional improvement in Time in Range (TIR)
Incremental cost per additional improvement in Time in Range (TIR) at 6 months of medication treatment, and at 6 months after discontinuation of medication
Measured: 6 months of medication treatment, and at 6 months after discontinuation of medication
Incremental cost per QALY gained
Incremental cost per QALY gained, derived from EQ-5D-5L assessments at baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
Measured: at baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A (triple combination therapy group): semaglutide, empagliflozin, and pioglitazone treatment. Group B (standard therapy group): metformin-based treatment is recommended when not contraindicated.
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbing Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946628
- Sponsor's protocol ID
- New Triple-2025
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Semaglutide, Empagliflozin and Pioglitazone Versus Standard Therapy in Newly Diagnosed Type 2 Diabetes: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06946628
- Acronym / sponsor ID
- New Triple-2025
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM.
- 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:
- Take new triple combination therapy or a standard therapy every day for 6 months
- Visit the clinic once every 0.5-1 month for checkups and tests
- Keep a diary of their fingertip blood glucose and adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A (triple combination therapy group): semaglutide, empagliflozin, and pioglitazone treatment. Group B (standard therapy group): metformin-based treatment is recommended when not contraindicated.
| Arm | Type | Receives |
|---|---|---|
| Group A (triple combination therapy group) | Experimental | Drug: Group A (triple combination therapy group)semaglutide, empagliflozin, and pioglitazone treatment. 1) Initiate with Semaglutide 0.25 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, if blood glucose is not controlled, adjust to Semaglutide 0.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd. If Semaglutide is well-tolerated, increase to 1 mg qw after 1 week; 3)If blood glucose remains uncontrolled after 1 month, add basal insulin therapy. |
| Group B (standard therapy group) | Active comparator | Drug: Group B (standard therapy group)metformin-based treatment is recommended when not contraindicated. 1).Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After another month, if blood glucose remains uncontrolled, add Semaglutide 0.25 mg qw, then increase to 0.5 mg qw after 1 month. If well-tolerated, increase to 1.0 mg qw after 1 week; 4) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A (triple combination therapy group)1) Initiate with Semaglutide 0.25 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, if blood glucose is not controlled, adjust to Semaglutide 0.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd. If Semaglutide is well-tolerated, increase to 1 mg qw after 1 week; 3)If blood glucose remains uncontrolled after 1 month, add basal insulin therapy. | Drug | Group A (triple combination therapy group) |
| Group B (standard therapy group)metformin-based treatment is recommended when not contraindicated. 1).Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After another month, if blood glucose remains uncontrolled, add Semaglutide 0.25 mg qw, then increase to 0.5 mg qw after 1 month. If well-tolerated, increase to 1.0 mg qw after 1 week; 4) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy. | Drug | Group B (standard therapy group) |
Primary outcome
Diabetic remission rate
Time frame: 6 months after discontinuation of medication
Diabetic remission rate at 6 months after discontinuation of medication (percentage of patients with HbA1c <6.5% at 6 months after discontinuation of medication)
14 secondary outcomes
Diabetic remission rate
Time frame: 3 and 12 months after discontinuation of medication
Time required to achieve glycemic goal
Time frame: 6 months of medication
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
Incremental cost per additional remission
Time frame: 6 months after discontinuation of medication
HbA1c
Time frame: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood glucose level
Time frame: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood insulin level
Time frame: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood C-peptide level
Time frame: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Pancreatic β-cell function
Time frame: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Insulin resistance
Time frame: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Weight changes
Time frame: baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Time in range (TIR)
Time frame: At baseline, at 6 months of medication treatment, and at 6 months after discontinuation of medication
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group A (triple combination therapy group) and Group B (standard therapy group) in people with Diabetes Mellitus, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hai Li, MD, PHD (+86-15920362668, lihai8@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic remission rate (time frame: 6 months after discontinuation of medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.