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
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 598
Study Start Date: May 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin 1
titrated
Drug: Rosuvastatin
Oral
Other Name: Crestor
Experimental: Rosuvastatin 2
Non-titrated
Drug: Rosuvastatin
Oral
Other Name: Crestor

  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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747149

  Show 84 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Davide Meani AstraZeneca
Principal Investigator: David Lau, MD Private Practice
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00747149     History of Changes
Other Study ID Numbers: D3560L00072
Study First Received: September 2, 2008
Results First Received: August 6, 2010
Last Updated: August 29, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by AstraZeneca:
diabetes
type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014