A Diabetes Study to Treat A Population Previously Not at Target (ADAPT)

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00747149

D3560L00072

Details and patient eligibility

About

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.

Enrollment

598 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).