Henagliflozin–metformin extended-release versus metformin for newly diagnosed type 2 diabetes

Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients With New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study

This trial tests whether a once-daily henagliflozin–metformin extended-release pill helps people with newly diagnosed type 2 diabetes lower their HbA1c better than standard metformin with lifestyle changes.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 268 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Provincial People's Hospital (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06888050 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, phase 4 study will enroll 268 adults with new-onset type 2 diabetes and randomly assign them 1:1 to either henagliflozin–metformin extended-release (5 mg/500 mg once daily) plus lifestyle intervention or metformin (500 mg twice daily) plus lifestyle intervention. The primary endpoint is change in glycated hemoglobin (HbA1c) from baseline at 24 weeks, with secondary outcomes including fasting and postprandial glucose, body weight, metabolic parameters, diabetes remission rate, and safety assessments. Eligible participants are 18–75 years old with disease duration ≤24 months, HbA1c 7.0–9.0%, fasting venous glucose ≤11.1 mmol/L, BMI ≥18.5 kg/m2, and no prior use of hypoglycemic drugs. The trial is led by Zhejiang Provincial People's Hospital with pharmaceutical collaboration and is intended to provide evidence on early combination therapy in newly diagnosed patients.

Who should consider this trial

Good fit: Adults 18–75 years with newly diagnosed (≤24 months) type 2 diabetes, HbA1c between 7% and 9%, fasting venous glucose ≤11.1 mmol/L, BMI ≥18.5 kg/m2, and no prior use of diabetes medications.

Not a fit: People with type 1 diabetes, long-standing diabetes, HbA1c outside the specified range, prior hypoglycemic treatment, or recent severe metabolic complications are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this regimen could offer once-daily combination therapy that improves blood sugar control and may help reduce weight for people with newly diagnosed type 2 diabetes.

How similar studies have performed: Other trials combining an SGLT2 inhibitor with metformin have shown improved glycemic control and weight effects, though this specific henagliflozin–metformin extended-release formulation is less widely studied.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiaohong Wu

Conditions New-onset Type 2 Diabetes