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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

598

Phase

  • 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

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
Intervention / Treatment
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

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

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

AstraZeneca

Investigators

  • 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

May 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

August 31, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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