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New combo pill aims to simplify diabetes care from day one

NCT ID NCT06888050

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a once-daily combination of henagliflozin and metformin works better than standard metformin alone in people newly diagnosed with type 2 diabetes. 268 adults will take either the combo pill or metformin twice a day for 24 weeks. Researchers will measure changes in blood sugar, weight, and how many achieve diabetes remission.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Henagliflozin proline and metformin hydrochloride extended-release tablets
What this could lead to
If successful, this could show that a once-daily combination pill controls blood sugar and weight better than standard metformin alone in early diabetes.
What could go wrong
This is a Phase 4 study, so the drugs are already approved; the main question is whether the combo is significantly better. Side effects like urinary infections or dehydration are possible with henagliflozin.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 268 people

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

Started

Apr 2025

Expected to finish

Dec 2026

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: * Age between 18 and 75 years old. * Diagnosed with type 2 diabetes according to WHO diagnostic criteria, with HbA1c between 7% and 9% at this examination, fasting venous blood glucose ≤ 11.1 mmol/L, and BMI ≥ 18.5 kg/m2; known disease duration ≤ 24 months. * Voluntary participation in this study and signing of the informed consent form. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness must be present to observe the informed consent process and sign the informed consent form on their behalf. * No previous use of hypoglycemic drugs. Exclusion Criteria: * Type 1 diabetes. * Participants who have participated in other clinical trials of diabetes treatment drugs before the start of this study. * Those who have experienced diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non-ketotic coma within the past six months and required hospitalization. * Those who have experienced decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, undergone cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within the past six months. * Those taking glucocorticoid drugs (excluding topical or inhaled medications). * Those with a life expectancy of less than one year due to malignant tumors, active tuberculosis, or acute infections. * Those with clinically significant urinary tract or genital infections, or a history of recurrent urinary tract or genital infections. * Those with a history of hypertension whose blood pressure has not been effectively controlled despite antihypertensive drug treatment: systolic blood pressure (SBP) \> 160 mmHg and/or diastolic blood pressure (DBP) \> 100 mmHg. * Those with liver and kidney function indicators meeting the following criteria: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 3.0×ULN; estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73 m² (calculated according to the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula). * Those allergic to the investigational drug or its components. * Pregnant or lactating women and those with the intention to conceive within three months of the last dose. * Other patients deemed unsuitable for participation in this clinical trial by 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

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310000, China