Compare the Impact of Xuezhikang and Atorvastatin on Glucose Metabolism in Dyslipidemia Patients With Prediabetes

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective, randomized, open-label, multi-center trial. The primary objective of the study is to assess whether XZK 1200mg/d, compared to atorvastatin 20mg/d, has a favorable impact on HbA1c levels at 24 weeks of treatment in dyslipidemia patients with prediabetes

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heart Health Research Center
• Collaborator: AstraZeneca
• Treatments: Atorvastatin; Calcium

Criteria

Inclusion Criteria:

• 1. Written informed consent provided

• 2. Age ≥40 years

• 3 Diagnosed Prediabetes, meeting one of the following conditions: ü Impaired fasting glucose (IFG): 5.6 mmol/L ≤ FPG <7.0 mmol/L ; ü Impaired glucose tolerance (IGT): 7.8mmol/L ≤ 2h PPG during 75g OGTT <11.0 mmol/L; ü HbA1c 5.7-6.4% (39-47 mmol/mol)

• 4. Dyslipidemia meets one of the following conditions: ü Fasting LDL-C ≥3.4mmol/L and<4.9mmol/L，and TG≤5.6 mmol/L ü Fasting non-HDL-C ≥4.1mmol/L and < 5.7 mmol/L , and TG≤5.6 mmol/L

• 5. Completed one-week Patient diary, recorded at least 5 days in a week.

Exclusion Criteria:

• 1. Patient with proven or documented atherosclerotic cardiovascular disease (ASCVD), including acute coronary syndrome (ACS), history of myocardial infarction (MI), stable or unstable angina pectoris, coronary or other revascularization, ischemic stroke, transient ischemic attack and peripheral vascular disease (PAD), etc.

• 2.Diagnosed diabetes According to 2021 the American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" FPG≥126mg/dL(7.0mmol/L). 2-hPG≥200mg/dL(11.1mmol/L)duringOGTT. A1C≥6.5%(48mmol/mol). In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).

• 3. Patientswithanylipidloweringdrugsintheprevious3months,includingbut not limited to statins, bile acid sequestrants, cholesterol absorption inhibitors, PCSK9 inhibitors, nicotinic acid, fibric acid derivatives, fibrates, other traditional Chinese medicine and n-3 fatty acids.

• 4.Patientswithanyantidiabeticdrugs.

• 5.ContraindicationstoXZKorAtorvastatin: Allergic to XZK or Atorvastatin. Pregnancy or breastfeeding

• 6.Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg and/ or diastolic blood pressure ≥110 mm Hg) at screening.

• 7.Active liver disease or hepatic dysfunction, including continuously elevated liver transaminase due to unknown causes. Abnormal liver function test at baseline (ALT or AST >3×ULN).

• 8. Knownrenaldysfunctionorelevatedserumcreatininelevelsatbaseline(with an eGFR≤60 mL/min/1.73 m2).

• 9.Otherendocrinediseasesthatmightinfluencethelevelsoflipidorlipoprotein, such as hypothyroidism.

• 10.Patient has participated in clinical trials of other drugs in the past three months.

• 11.Previous statin treatment causes creatine kinase (CK) increased 10 times, or myalgia myopathy (muscle pain or muscle weakness, accompanied by Creatine phosphokinase (CK) exceeds 10 times the ULN)

• 12.Estimated life expectancy < 6 months at the time of enrollment

• 13.Abuse of alcohol, or history of alcohol abuse.

• 14.Close affiliation with the investigators, e.g., a close relative for the investigator, dependent person (e.g., employee or student of the investigators)