An open-label, prospective, non-comparative clinical trial to evaluate the efficacy and safety of rosuvastatin in high risk Indian population with diabetes and dyslipidemia

Completed

• Conditions: Diabetes patients with dyslipidemia; Nutritional, Metabolic, Endocrine; Dyslipidemia

• Registration Number: ISRCTN22416062
• Lead Sponsor: Ranbaxy Laboratories Ltd (India)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

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

Inclusion Criteria

1. Diabetes type II defined by American Diabetes Association criteria of fasting venous plasma glucose of greater than or equal to 126 mg/dl, two-hour post prandial plasma glucose of greater than or equal to 200 mg/dl or already on treatment of diabetes
2. Dyslipidemia defined by Low Density Lipoprotein (LDL) cholesterol more than 100 mg/dl or on prior statin therapy
3. Age of greater than or equal to 30 and less than or equal to 70 years
4. Informed consent by the patient

Exclusion Criteria

1. Failure to give informed consent
2. A history of hypersensitivity to statins
3. Evidence of fundoscopy grade 2 hypertensive or diabetic retinopathy
4. Serum creatinine greater than 1.5 mg/dl
5. Overt proteinuria
6. Pregnant or lactating mothers
7. Evidence/history of heart failure
8. Systolic blood pressure above 180 mmHg and diastolic blood pressure above 110 mmHg
9. Recent history of cerebrovascular disease, myocardial infarction, unstable angina, new onset Left Bundle Branch Block (LBBB) in the past 4 weeks
10. Documented case of homozygous familial hypercholesterolemia
11. Type I Diabetes Mellitus (DM)
12. Use of concomitant medications (cyclosporin, systemic itraconazole or ketoconazole, erythromycin, or clarithromycin, glucocorticoids or verapamil) known to affect the lipid profile or with potency safety concern
13. Recent ongoing inter-current infection/high sensitivity C-Reactive Protein (hsCRP) greater than 10 mg/L
14. Active liver disease or hepatic dysfunction (defined as Alanine aminotransferase [ALT], aspartate aminotransferase [AST], Gamma-Glutamyl Transferase [GGT], alkaline phosphate or bilirubin levels greater than or equal to 1.5 the upper limit of normal)
15. Diagnosed to have any other endocrinal or metabolic disease other than Type II DM that is known to influence serum lipids and lipoproteins
16. Patients having history suggestive of myalgia/myositis/arthralgia
17. Serious or unstable medical or psychological condition that could compromise the patient?s safety or successful trial participation
18. History of alcohol consumption greater than 2 drinks/day (30 ml) or 10 drinks per week

Study & Design

• Study Type: Interventional
• Study Design: Not specified