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

NCT05238012 | Completed Phase 4

• 1 other identifier: ESR-21-21279
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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 on HbA1c levels at 24 weeks of treatment in dyslipidemia patients with prediabetes

Conditions

Metabolism Disorder, Lipid; Metabolism Disorder, Glucose

Keywords

Dyslipidemia; Prediabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c levels

  To determine whether XZK 1200mg/d, compared to atorvastatin 20mg/d, has a favorable impact on HbA1c levels from baseline to 24 weeks in dyslipidemia patients with prediabetes.

  24 weeks

Secondary Outcomes (11)

• Fasting blood glucose(FBG),

  24 weeks

• Post prandial glucose(PPG) 2h

  24 weeks

• HOMA-IR

  24 weeks

• LDL-C levels

  24 weeks

• non HDL-C levels

  24 weeks

Study Arms (2)

Xuezhikang Capsule

EXPERIMENTAL

Experimental drug: Xuezhikang Capsule, specification: 300mg / capsule.

Drug: Xuezhikang Capsule

Atorvastatin Calcium Tablets

ACTIVE COMPARATOR

Control drug: Atorvastatin Calcium Tablets, specification: 20mg / tablet.

Drug: Atorvastatin Calcium Tablets

Interventions

Xuezhikang Capsule DRUG

Xuezhikang Capsule, 1200mg / day, twice a day, 2 capsules each time, after meals in the morning and evening.

Xuezhikang Capsule

Atorvastatin Calcium Tablets DRUG

Atorvastatin Calcium Tablets, 20mg/day, once a day, one tablet each time, before bedtime;

Atorvastatin Calcium Tablets

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Written informed consent provided
• \. Age ≥40 years
• 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)
• \. 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
• \. Completed one-week Patient diary, recorded at least 5 days in a week.

You may not qualify if:

• \. 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).
• \. 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).
• \. 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)

Sponsors & Collaborators

• Heart Health Research Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders; Glucose Metabolism Disorders; Dyslipidemias; Prediabetic State

Interventions

xuezhikang; Atorvastatin

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Changsheng Ma, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental group: Xuezhikang Capsule, 1200mg / day, twice a day, 2 capsules each time, after meals in the morning and evening. Control group: Atorvastatin Calcium Tablets, 20mg/day, once a day, one tablet each time, before bedtime; Continuous treatment for 24 weeks.

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 14, 2022
• Study Start: August 2, 2022
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (1)