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

ISRCTN	ISRCTN72526711
DOI	https://doi.org/10.1186/ISRCTN72526711
Protocol serial number	N/A
Sponsor	Chinese University of Hong Kong
Funder	Chinese University of Hong Kong (investigator-initiated study)

Submission date: 13/01/2006
Registration date: 01/03/2006
Last edited: 01/03/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Francis C.C. Chow
Scientific

Flat 8A
Block B
Staff Quarters
Prince of Wales Hospital
Shatin, New Territories
-
Hong Kong

Study information

Primary study design	Interventional
Study design	Randomized, open-labelled, parallel-group study using rosuvastatin 5 mg daily, 10 mg daily or 10 mg on alternate days in patients with Low-Density Lipoprotein (LDL) Cholesterol >/= 2.6 mmol/l after following a standard lipid lowering diet
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Alternate day dosing of rosuvastatin 10 mg is comparable to daily dosing of rosuvastatin 5 mg
Ethics approval(s)	Study protocol, informed consent documents, any addenda or amendments have been reviewed and approved jointly by the Chinese University of Hong Kong, New Territories and the East Cluster Clinical Research Ethics Committee, reference number CRE-2005.095-T
Health condition(s) or problem(s) studied	Dyslipidaemia
Intervention	Drug intervention: rosuvastatin 5 mg daily or 10 mg daily or 10 mg on alternate days
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Rosuvastatin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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 clearance as assessed at 12 and 24 weeks
Completion date	18/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	18/06/2005
Date of final enrolment	18/12/2006

Locations

Countries of recruitment

Hong Kong

Study participating centre

Flat 8A

Shatin, New Territories
-
Hong Kong

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan