Status:
COMPLETED
Compare the Impact of Xuezhikang and Atorvastatin on Glucose Metabolism in Dyslipidemia Patients With Prediabetes
Lead Sponsor:
Heart Health Research Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Metabolism Disorder, Lipid
Metabolism Disorder, Glucose
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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 o...
Detailed Description
Up to now, there is no published RCTs to compare the impact of XZK and statins on glucose metabolism in Prediabetes with dyslipidemia. However, systematic reviews of several large observational studie...
Eligibility Criteria
Inclusion
- 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 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
- 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.
- Diagnosed diabetes According to 2021 the American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" FPG≥126mg/dL(7.0mmol/L). A know 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.
- Patientswithanyantidiabeticdrugs.
- ContraindicationstoXZKorAtorvastatin: Allergic to XZK or Atorvastatin. Pregnancy or breastfeeding
- Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg and/ or diastolic blood pressure ≥110 mm Hg) at screening.
- 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).
- Otherendocrinediseasesthatmightinfluencethelevelsoflipidorlipoprotein, such as hypothyroidism.
- Patient has participated in clinical trials of other drugs in the past three months.
- 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)
- Estimated life expectancy \< 6 months at the time of enrollment
- Abuse of alcohol, or history of alcohol abuse.
- Close affiliation with the investigators, e.g., a close relative for the investigator, dependent person (e.g., employee or student of the investigators)
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT05238012
Start Date
August 2 2022
End Date
April 2 2024
Last Update
May 21 2024
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China