Trial comparing treatments for New-onset Type 2 Diabetes
Official title 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
ClinicalTrials.gov ID: NCT06888050
What this study is testing
What is henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ)?
henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for new-onset type 2 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This multicenter, randomized controlled trial aims to evaluate the efficacy and safety of Henagliflozin-Metformin Sustained-Release Tablets (I) versus Metformin Tablets in newly diagnosed type 2 diabetes mellitus (T2DM). A total of 268 participants will be randomized (1:1) into two groups: the experimental group receiving Henagliflozin-Metformin Sustained-Release Tablets (I) (5mg/500mg, once daily) with lifestyle intervention, and the control group receiving Metformin Tablets (500mg, twice daily) with lifestyle intervention.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 ≤...
- 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...
- No previous use of hypoglycemic drugs.
You likely can't join if
- 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...
- Those who have experienced decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial...
- 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.
See the full eligibility 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 people), a witness must be present to observe the informed...
- No previous use of hypoglycemic drugs.
- 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...
- 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) \>...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.