A Diabetes Study to Treat A Population Previously Not at Target - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00747149

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Rosuvastatin	Phase IV

MedlinePlus related topics: Cholesterol Diabetes

Drug Information available for: Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)- BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	12-Week, Open-Label, Multi-Center, Prospective Study Evaluating the Effect of Individualizing Starting Doses of Rosuvastatin According to Baseline LDL-Cholesterol Levels on Achieving Cholesterol Targets in Type 2 Diabetic Patients

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Proportion of subjects achieving Canadian LDL-C target goals (i.e. LDL-C < 2.0 mmol/L). [ Time Frame: after 12 weeks of rosuvastatin therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects achieving TC/HDL-C ratio (i.e. TC/HDL < 4.0 mmol/L) [ Time Frame: at 6 and 12 weeks of treatment ] [ Designated as safety issue: No ]
Mean percent change in TC, LDL-C, HDL-C,TC/HDL-C ratio, Non-HDL-C, Triglycerides and ApoB/ApoA-1 ratio [ Time Frame: at 6 and 12 weeks ] [ Designated as safety issue: No ]
Mean hsCRP value [ Time Frame: at week 6 and 12 ] [ Designated as safety issue: No ]
Incidence of adverse events and abnormal laboratory values [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	May 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Type 2 diabetes
Previously treated with a commonly accepted start dose of a statin (see Appendix I) 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 in Appendix I
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%; (see Appendix H)
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747149

Contacts

Contact: Canada Clinical Study Information

1-800 565-5877

Show 84 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jefferson Tea	AstraZeneca
Principal Investigator:	David Lau, MD	Private Practice

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	AstraZeneca ( Michael Cressman - Medical Science Director )
Study ID Numbers:	D3560L00072
Study First Received:	September 2, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00747149
Health Authority:	Canada: Ethics Review Committee

Keywords provided by AstraZeneca:

diabetes
type 2

Study placed in the following topic categories:

Rosuvastatin
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009