Henagliflozin's Impact on Prediabetes Remission

Prior treatment

• Previously diagnosed with diabetes;
• Use of GLP-1 receptor agonists, orlistat, or other weight-reducing drugs in the past 3 months;
• Persistently uncontrolled hypertension (used antihypertensive drugs but was not effectively controlled in the 3 months prior to enrollment) or currently use 3 or more antihypertensive drugs (including diuretics);
• Enrolled in another clinical trial currently or within the 3 months prior to enrollment;

Other illness

• Allergic to Henagliflozin;
• Assessed by the investigator to be at high risk of genitourinary system infections, such as history of recurrent urinary tract infections or reproductive system infections, long-term placement of urinary catheters, or history of urological surgery;
• Other obesity caused by endocrine disorders, such as Cushing's syndrome;
• Impaired consciousness and various mental health disorders;
• Malignant tumors and other serious illnesses;

Lab values

• HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol/L or PPG ≥ 11.1 mmol/L;
• Use of drugs affecting glucose synthesis, absorption, or metabolism, such as glucocorticoids (e.g., prednisone, dexamethasone), contraceptives, growth hormone, hormonal replacement therapy (estrogen and progesterone), immunosuppressants (e.g., cyclosporine A, tacrolimus), anti-tuberculosis drugs (e.g., isoniazid, rifampicin);
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 3 times of the upper limit of the normal range (UNL);
• eGFR less than 30 mL/min/1.73 m2, severe kidney damage, end-stage renal disease or requiring dialysis;
• Significant cardiovascular diseases including myocardial infarction, congestive heart failure (≥grade III New York Heart Association), left ventricular ejection fraction≤40%, or cerebrovascular accidents;

Other

• Fluctuation in weight by 5% or more in the past month;
• Untreated hyperthyroidism or hypothyroidism, excluding those with normal thyroid function after treatment;
• Pregnant or breast-feeding or planning pregnancy within 24 months;
• Identified by the investigator that lacks sufficient motivation to continue the long-term clinical trial (e.g., out-of-town study, work plan, need to care for family members), or considered prefer to withdraw from the trial for non-medical reasons (such as social issues).

• Male or female subjects between the ages of 18 and 65 years;
• Individuals without hypoglycemic therapy before, including hypoglycemic drugs or traditional Chinese medicine formulations with hypoglycemic effects;
• Prediabetic patients as defined by Expert Consensus on Intervention for Prediabetes in Chinese Adults, 2023 Edition:1)Fasting plasma glucose (FPG) between 6.1 and 7.0 mmol/L and/or 2-hour postprandial glucose (2h-PPG) between 7.8 and 11.1 mmol/L; 2)And/or HbA1c between 5.7% and 6.5%;
• Individuals willing to provide written informed consent and can comply with study procedures and follow-up.