Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients

Launched by YANGJIN · Jun 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called SGLT2 inhibitors to see how safe and effective it is for people who are pre-diabetic. Pre-diabetes means that your blood sugar levels are higher than normal but not high enough to be classified as diabetes. The trial aims to find out if SGLT2 inhibitors can help improve blood sugar levels and prevent the progression to type 2 diabetes.

To participate in this trial, you need to be between 18 and 65 years old and have been diagnosed with pre-diabetes within the last six months. You should not be taking any diabetes medications or weight-loss drugs during this time. If you join the study, you will receive the SGLT2 inhibitor medication and be monitored for its effects. This trial is important because it may offer an alternative treatment option for people who can't tolerate other diabetes medications. If successful, it could help many individuals maintain better blood sugar control and reduce the risk of developing diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 \~65 years old;
• • 2. OGTT received within half a year and were diagnosed with prediabetes In accordance with the gout classification criteria of the American Diabetes Association: ① Fasting blood glucose (FPG)≥6.1 mmol/L and \< 7.0 mmol/L; ② The blood glucose (2h-PG) concentration at OGTT 2h was ≥7.8 and \< 11.1mmol/L; ③ Glycosylated hemoglobin (HbA1c) ≥5.7% and \< 6.4%;
• • 3. No antidiabetic drugs (including traditional Chinese medicine) were taken within 6 months before screening;
• • 4. Sign the informed consent form.
• Exclusion Criteria:
• • 1. Diagnosed with diabetes;
• • 2. Taking medications that affect glucose and lipid metabolism (excluding thiazide diuretics at a daily dose of ≤ 12.5 mg);
• • 3. Taking weight-loss drugs (including traditional Chinese medicine) within 6 months before screening;
• • 4. Patients with acute infection, surgery, acute alcoholism, mental illness, etc;
• • 5. Patients with liver and kidney dysfunction, severe chronic gastrointestinal disease, uncontrolled thyroid disease, cancer, and ventilator use;
• • 6. Systolic blood pressure ≥180 mmHg (1 mmHg = 0.133 kPa) or diastolic blood pressure ≥110 mmHg at screening;
• • 7. Electrocardiogram within 12 weeks before screening indicating arrhythmia requiring urgent diagnosis or treatment (e.g., clinically newly identified severe arrhythmia or conduction disturbance), myocardial infarction, unstable angina, or stroke requiring cardiovascular and cerebrovascular intervention;
• • 8. A history of traumatic amputation within the past year, or active skin ulcers, osteomyelitis, gangrene, or critical lower limb ischemia within the past 6 months;
• • 9. Enrolled in drug/device clinical studies (including vaccines) within 12 weeks before screening;
• • 10. Pregnant, lactating women, or those planning a recent pregnancy;
• • 11. Allergic constitution or multi-drug allergy;
• • 12. Receiving bariatric surgery within the past 2 years.