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New triple therapy aims to reverse early diabetes

NCT ID NCT07635953

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of three diabetes drugs (tirzepatide, empagliflozin, and pioglitazone) can help people newly diagnosed with type 2 diabetes achieve remission—meaning their blood sugar stays normal even after stopping medication. About 296 adults will take either the triple therapy or standard metformin-based treatment for 6 months, then stop and be monitored for up to a year. The goal is to see if the triple combo is better at restoring normal blood sugar control without needing lifelong drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 296 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.