A Diabetes Study to Treat A Population Previously Not at Target

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT00747149
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-08-06
• Results First Submitted QC: 2011-06-07
• Results First Posted: 2011-07-04
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 598

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin 1	Rosuvastatin	titrated
Rosuvastatin 2	Rosuvastatin	Non-titrated

Primary Outcome Measures

Name	Time	Method
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	12 Weeks	The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100

Secondary Outcome Measures

Name	Time	Method
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	6 and 12 Weeks	Proportion 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
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	6 and 12 Weeks
Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12	6 and 12 Weeks
Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy	6 and 12 Weeks

Trial Locations

Locations (1)

Research Site; 🇨🇦 Quebec, Canada