New combo pill aims to simplify diabetes care from day one
NCT ID NCT06888050
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 268 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Zhejiang Provincial People's Hospital
RECRUITINGHangzhou, Zhejiang, 310000, China