A randomized, open-labelled, parallel, comparative study of the efficacy and tolerability of rosuvastatin in low-density lipoprotein-cholestrol reduction using different dosing regimens of 5 mg daily, 10 mg daily and 10 mg on alternate days in Hong Kong Chinese type 2 diabetic patients

Completed

• Conditions: Dyslipidaemia; Circulatory System

• Registration Number: ISRCTN72526711
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-01
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>2. Effects on glycemic control as determined by fasting glucose and HbA1c at 12 weeks and 24 weeks<br>3. Effects on insulin resistance as determined by Homeostasis Model Assessment (HOMA) at 12 and 24 weeks<br> 4. Effects on urinary albumin excretion and creatinine clearance as assessed at 12 and 24 weeks