Henagliflozin's Impact on Prediabetes Remission

Launched by SHANDONG PROVINCIAL HOSPITAL · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a medication called Henagliflozin works for people with prediabetes, especially when combined with lifestyle changes like diet and exercise. Prediabetes is a condition where blood sugar levels are higher than normal but not high enough to be classified as diabetes. The study will involve about 984 adults aged 18 to 65 years who meet specific health criteria, such as having certain blood sugar levels. Participants will be randomly assigned to receive either Henagliflozin in different doses or a placebo (a pretend medication) for six months, followed by an 18-month follow-up period to see how their health changes over time.

To be eligible for this trial, individuals should not be on any diabetes medications and must meet specific blood sugar level criteria. Throughout the study, participants will have regular health check-ups to monitor their blood sugar and overall health, helping researchers understand if Henagliflozin can help bring blood sugar levels back to normal. This trial aims to find new ways to manage prediabetes and potentially prevent it from progressing to type 2 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects between the ages of 18 and 65 years;
• • 2. Individuals without hypoglycemic therapy before, including hypoglycemic drugs or traditional Chinese medicine formulations with hypoglycemic effects;
• • 3. 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%;
• • 4. Individuals willing to provide written informed consent and can comply with study procedures and follow-up.
• Exclusion Criteria:
• • 1. Allergic to Henagliflozin;
• • 2. Previously diagnosed with diabetes;
• • 3. HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol/L or PPG ≥ 11.1 mmol/L;
• • 4. Use of GLP-1 receptor agonists, orlistat, or other weight-reducing drugs in the past 3 months;
• • 5. Fluctuation in weight by 5% or more in the past month;
• • 6. 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);
• • 7. Untreated hyperthyroidism or hypothyroidism, excluding those with normal thyroid function after treatment;
• • 8. 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);
• • 9. 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;
• • 10. Other obesity caused by endocrine disorders, such as Cushing's syndrome;
• • 11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 3 times of the upper limit of the normal range (UNL);
• • 12. eGFR less than 30 mL/min/1.73 m2, severe kidney damage, end-stage renal disease or requiring dialysis;
• • 13. Significant cardiovascular diseases including myocardial infarction, congestive heart failure (≥grade III New York Heart Association), left ventricular ejection fraction≤40%, or cerebrovascular accidents;
• • 14. Impaired consciousness and various mental health disorders;
• • 15. Malignant tumors and other serious illnesses;
• • 16. Pregnant or breast-feeding or planning pregnancy within 24 months;
• • 17. Enrolled in another clinical trial currently or within the 3 months prior to enrollment;
• • 18. 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).