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

August 29, 2011 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
598

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
      • Red Deer, Alberta, Canada
        • Research Site
      • Spruce Grove, Alberta, Canada
        • Research Site
      • St Albert, Alberta, Canada
        • Research Site
    • British Columbia
      • Chilliwack, British Columbia, Canada
        • Research Site
      • Coquitlam, British Columbia, Canada
        • Research Site
      • Delta, British Columbia, Canada
        • Research Site
      • Kelowna, British Columbia, Canada
        • Research Site
      • Maple Ridge, British Columbia, Canada
        • Research Site
      • Penticton, British Columbia, Canada
        • Research Site
      • Victoria, British Columbia, Canada
        • Research Site
    • Manitoba
      • Portage La Prairie, Manitoba, Canada
        • Research Site
      • Winnipeg, Manitoba, Canada
        • Research Site
    • New Brunswick
      • Bathurst, New Brunswick, Canada
        • Research Site
      • Woodstock, New Brunswick, Canada
        • Research Site
    • Newfoundland and Labrador
      • Carbonear, Newfoundland and Labrador, Canada
        • Research Site
      • Mount Pearl, Newfoundland and Labrador, Canada
        • Research Site
      • St John's, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
      • Kentville, Nova Scotia, Canada
        • Research Site
      • Pubnico, Nova Scotia, Canada
        • Research Site
      • Sydney Mines, Nova Scotia, Canada
        • Research Site
      • Truro, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Aylmer, Ontario, Canada
        • Research Site
      • Bolton, Ontario, Canada
        • Research Site
      • Chatham, Ontario, Canada
        • Research Site
      • Fort Erie, Ontario, Canada
        • Research Site
      • Georgetown, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Kingston, Ontario, Canada
        • Research Site
      • Kitchener, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Morrisburg, Ontario, Canada
        • Research Site
      • Nepean, Ontario, Canada
        • Research Site
      • Newmarket, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Oshawa, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Scaborough, Ontario, Canada
        • Research Site
      • Scarborough, Ontario, Canada
        • Research Site
      • Smith Falls, Ontario, Canada
        • Research Site
      • St Catherines, Ontario, Canada
        • Research Site
      • St. Catharines, Ontario, Canada
        • Research Site
      • Sudbury, Ontario, Canada
        • Research Site
      • Thornhill, Ontario, Canada
        • Research Site
      • Thorold, Ontario, Canada
        • Research Site
      • Thunder Bay, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • Welland, Ontario, Canada
        • Research Site
      • Willowdale, Ontario, Canada
        • Research Site
      • Windsor, Ontario, Canada
        • Research Site
      • Woodstock, Ontario, Canada
        • Research Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • Research Site
      • Kensington, Prince Edward Island, Canada
        • Research Site
      • Montague, Prince Edward Island, Canada
        • Research Site
    • Quebec
      • Anjou, Quebec, Canada
        • Research Site
      • Dolbeau-mistassini, Quebec, Canada
        • Research Site
      • Drummondville, Quebec, Canada
        • Research Site
      • Forestville, Quebec, Canada
        • Research Site
      • Gatineau, Quebec, Canada
        • Research Site
      • Joliette, Quebec, Canada
        • Research Site
      • L'ile- Perrot, Quebec, Canada
        • Research Site
      • La Sarre, Quebec, Canada
        • Research Site
      • Laval, Quebec, Canada
        • Research Site
      • Longueuil, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
      • Roberval, Quebec, Canada
        • Research Site
      • Roxton Pond, Quebec, Canada
        • Research Site
      • Saint-bruno-lac-saint-jean, Quebec, Canada
        • Research Site
      • Saint-charles-borromee, Quebec, Canada
        • Research Site
      • Saint-leonard, Quebec, Canada
        • Research Site
      • Saint-marc-des-carrieres, Quebec, Canada
        • Research Site
      • Saint-pie, Quebec, Canada
        • Research Site
      • Sainte Gedeon-de-beauce, Quebec, Canada
        • Research Site
      • Sherbrooke, Quebec, Canada
        • Research Site
      • Thetford Mines, Quebec, Canada
        • Research Site
      • Trois-rivieres, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Moose Jaw, Saskatchewan, Canada
        • Research Site
      • Porcupine Plain, Saskatchewan, Canada
        • Research Site
      • Saskatoon, Saskatchewan, Canada
        • Research Site
      • Yorkton, Saskatchewan, Canada
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rosuvastatin 1
titrated
Drug: Rosuvastatin
Oral
Other Names:
  • Crestor
Experimental: Rosuvastatin 2
Non-titrated
Drug: Rosuvastatin
Oral
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
6 and 12 Weeks
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
6 and 12 Weeks
Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12
Time Frame: 6 and 12 Weeks
6 and 12 Weeks
Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy
Time Frame: 6 and 12 Weeks
6 and 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Davide Meani, AstraZeneca
  • Principal Investigator: David Lau, MD, Private Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3560L00072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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