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This study evaluates the effect of Rosuvastatin on the function of HDL ('good') cholesterol in people with type 2 diabetes. Adults aged 30 and older with type 2 diabetes, an HbA1c of 7.5% or higher, low HDL, and at least one cardiovascular risk factor were able to take part. The study was carried out in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Type 2 diabetes 2. HbA1c ≥ 7.5% 3. Age ≥ 30 4. low HDL-C (\<40 mg/dl in men or \<50 mg/dl in women) and having 1 or more risk factors: 1) Body mass index (BMI) ≥ 25 kg/m2 (overweight); 2) LDL-C level ≥ 130 mg/dl; 3) TG level ≥150 mg/dl; 4) Systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥140/90 mmHg or taking antihypertensive medication; 5) Current smoker; 6) Family history of CHD. Exclusion Criteria: 1. Contraindication to rosuvastatin 2. Pregnant or breast feeding women 3. Reproductive-age women who refuse contraception 4. Type 1 diabetes, gestational diabetes, or diabetes with secondary cause 5. Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal) 6. Renal failure (Cr \> 2.0) 7. Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) 8. Not appropriate for lipid lowering treatment 9. Medications which affect glycemic control 10. Diseases which affect efficacy and safety of statin 11. Other clinical trial within 30 days