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

Launched by ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a new medication called Henagliflozin-Metformin Sustained-Release Tablets compared to standard Metformin Tablets for people who have recently been diagnosed with type 2 diabetes. The study will involve 268 participants who will be randomly divided into two groups: one group will take the new medication along with some lifestyle changes, while the other group will take regular Metformin and also make lifestyle changes. The main goal is to see how much the medication can lower blood sugar levels over a 24-week period. Researchers will also look at other factors like weight changes and overall health.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a recent diagnosis of type 2 diabetes. They should not have used diabetes medications before and must meet specific health criteria. If you decide to participate, you can expect to visit a medical center for assessments and to receive the assigned medication. It's important to know that this study is currently not recruiting participants, but it aims to provide valuable information about the best treatment options for people who are newly diagnosed with diabetes.

Gender

ALL

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 ≤ 6 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.