Phase 4
Completed N=598
A Diabetes Study to Treat A Population Previously Not at Target
Source: ClinicalTrials.gov NCT00747149 ↗Enrolled (actual)
598
Serious AEs
0.7%
Results posted
Jul 2011
Primary outcomePrimary: Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy — 87; 87; 76; 63 Percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy |
87; 87; 76; 63 | — |
| SECONDARY Percentage of Subjects Achieving Total Cholesterol (TC)/ High-density Lipoprotein Cholesterol (HDLC) Ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 Weeks of Treatment |
— | — |
| SECONDARY Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio |
— | — |
| SECONDARY Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12 |
— | — |
| SECONDARY Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy |
— | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT00747149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.