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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 July 31, 2014