Study to evaluate the efficacy and safety of rosuvastatin in indian population who have diabetes with abnormal lipid levels (dyslipidemia)

Recruiting

• Conditions: Dyslipidemia in patients with Diabetes Mellitus; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12607000473460
• Lead Sponsor: Ranbaxy Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Diabetes Type II defined by American Diabetes Association (ADA) criteria of fasting venous plasma glucose of = 126 mg/dl, 2 hour post prandial plasma glucose of = 200 mg/dl or already on treatment of diabetes.
•Dyslipidemia defined by LDL Cholesterol more than 100 mg/dl or on prior statin therapy.
•Age of = 30 and = 70 years
•Informed consent by the patient.

Exclusion Criteria

•Failure to give informed consent
•A history of hypersensitivity to statins
•Evidence of Fundoscopy grade 2 hypertensive or diabetic retinopathy
•Serum creatinine > 1.5 mg/dl
•Overt Proteinuria
•Pregnant or lactating mothers
•Evidence / History of Heart Failure
•Systolic Blood Pressure above 180 mmHg and Diastolic Blood Pressure above 110 mmHg
•Recent history of Cerebrovascular disease, myocardial infarction, unstable angina, new onset LBBB in the past 4 weeks
•Documented case of homozygous familial hypercholesterolemia
•Type I Diabetes Mellitus
•Use of concomitant medications (cyclosporine, systemic itraconazole or ketoconazole, erythromycin, or clarithromycin, glucocorticoids or verapamil) known to affect the lipid profile or with potency safety concernRecent ongoing inter current infection / hs CRP > 10 mg/L
•Active liver disease or hepatic dysfunction (defined as alanine aminotransferase (ALT), aspartate aminotransferase, alkaline phosphate or bilirubin levels = 1.5 the upper limit of normal
•Diagnosed to have any other endocrinal or metabolic disease other than Type II DM that is known to influence serum lipids and lipoproteins
•Patients having history suggestive of myalgia / myositis / arthralgia
•Serious or unstable medical or psychological condition that could compromise the patient’s safety or successful trial participation
•History of alcohol consumption > 2 drinks/day (30 ml) or 10 drinks per week

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome will be measured by evaluating the blood samples of patients at Baseline, Week 6 and Week 12.<br>We will evaluate the mean change in the Total Cholesterol, Low Density Lipoprotein, High Denisty Lipoprotein, Triglycerides levels.[Baseline, Week 6 and Week 12]

Secondary Outcome Measures

Name	Time	Method
Mean Change in high sensitive-C-Reactive Protein, apoprotein B, apoB/apoA1 ratio, apoprotein A1, lipoprotein a and glycosylated hemoglobine[Baseline, Week 6 and Week 12]