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. The primary outcome is the change in glycated hemoglobin (HbA1c) from baseline at 24 weeks. Secondary outcomes include changes in fasting/postprandial blood glucose, body weight, metabolic parameters, diabetes remission rate, and safety assessments. This trial will provide evidence for early combination therapy in newly diagnosed T2DM patients.
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.
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.
Parallel
henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ)
Drughenagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) (5mg/500mg, once a day, two tablets each time) plus lifestyle intervention
Metformin
DrugMetformin (500mg, twice a day) plus lifestyle intervention
Glycosylated Hemoglobin, Type A1C（HbA1C）
Fasting blood glucose (FBG)
2-hour postprandial blood glucose (PBG)
Diabetes reversal rate
fasting insulin/C-peptide and postprandial 2-hour insulin/C-peptide
Click on the lead sponsor to view all of their trials.
Zhejiang Provincial People's Hospital
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Collaborator
