hyperliipidaemia
Conditions
Interventions
Two groups:rosuvastatin 5 mg daily or 10 mg daily or 10 mg on alternate days versus Rosuvastatin 10mg alt day is compared with Rosuvastatin 5mg qd and Rosuvastatin 10mg qd for 24 weeks
Sponsors
Dr Francis C.C. Chow
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetic patients 18 to 75 years of age; 2. Treated with diet alone, oral hypoglycemic agents and/or insulin; 3. LDL-Cholesterol >/= 2.6 mmol/l; 4. Dyslipidaemia persisting after diet control for eight weeks or more; 5. Alcohol consumption <50 g/day; 6. Not on treatment with drugs known to interfere with glucose tolerance or drugs that have a major effect on lipid metabolism e.g. thiazide diuretics and beta-blockers; 7. Good compliance to diet and drugs; 8. HbA1c <9% (glucosylated haemoglobin <9%); 9. Blood pressure <160/95 mmHg.
Exclusion criteria
Exclusion criteria: 1. Significantly impaired renal function (plasma creatinine >150 micromol; 2. Impaired liver function (Serum Glutamic Pyruvic Transaminase [SGPT] or alanine aminotransferase [ALT] twice the upper limit of normal); 3. Secondary dyslipidaemia, diabetic dyslipidaemia; 4. Pregnant women or those planning a pregnancy; 5. Lactation; 6. Progressive fatal disease; 7. History of drug or alcohol abuse; 8. History of hypersensitivity to study medication or drugs with a similar chemical structure; 9. Likelihood of requiring treatment during the study period with the following drugs: cyclosporine, erythromycin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change of LDL-Cholesterol at 12 weeks and 24 weeks from baseline parameter in the three study arms using different dosing regimes of rosuvastatin.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage change of total cholesterol, triglyceride levels and High-Density Lipoprotein-Cholesterol (HDL-C) at 12 weeks and 24 weeks from baseline parameters in the three study arms using different dosing regimes of rosuvastatin. 2. Effects on glycemic control as determined by fasting glucose and HbA1c at 12 weeks and 24 weeks. 3. Effects on insulin resistance as determined by Homeostasis Model Assessment (HOMA) at 12 and 24 weeks. 4. Effects on urinary albumin excretion and creatinine clear; | — |
Countries
China
Contacts
Public ContactDr Risa Ozaki
Outcome results
None listed