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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00747149
First received: September 2, 2008
Last updated: August 29, 2011
Last verified: August 2011

September 2, 2008
August 29, 2011
May 2008
August 2009   (final data collection date for primary outcome measure)
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 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
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
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 ]
Complete list of historical versions of study NCT00747149 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 6 and 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 and 12 Weeks ] [ Designated as safety issue: No ]
  • Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12 [ Time Frame: 6 and 12 Weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy [ Time Frame: 6 and 12 Weeks ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
A Diabetes Study to Treat A Population Previously Not at Target
12-week, Open-label, Multi-center, Prospective Study Evaluating the Effect of Individualizing Starting Doses of Rosuvastatin According to Baseline LDL (Low Density Lipoprotein)-Cholesterol Levels on Achieving Cholesterol Targets in Type 2 Diabetic Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Rosuvastatin
Oral
Other Name: Crestor
  • Experimental: Rosuvastatin 1
    titrated
    Intervention: Drug: Rosuvastatin
  • Experimental: Rosuvastatin 2
    Non-titrated
    Intervention: Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
598
August 2009
August 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00747149
D3560L00072
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Davide Meani AstraZeneca
Principal Investigator: David Lau, MD Private Practice
AstraZeneca
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP