A Diabetes Study to Treat A Population Previously Not at Target

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at LDL-C targets.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Diagnosis of Type 2 diabetes

• Previously treated with a commonly accepted start dose of a statin for the last 4 weeks prior to study entry

• Fasting LDL-C concentration of > 2.0 mmol/L (and ≤ 5.0 mmol/L) (in the past 3 months)

• History of serum TG level of ≤ 4.6 mmol/l (in the past 3 months)

Exclusion Criteria:

• If currently receiving therapy with any statin at a dose higher than listed

• Rosuvastatin (current use)

• Fibrates, niacin or resins that was not discontinued a minimum of 2 months prior to enrolment.

• Type 1 diabetes; glycated haemoglobin (HbA1c) > 9.0%

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 1.5 × upper limit of normal (ULN) (in the past 2 months)

• Resting diastolic or systolic blood pressure of > 95 mmHg or > 180 mmHg, respectively (in the past 2 months)

• Unexplained serum creatine kinase (CK) level > 3 × ULN (in the past 2 months).