Back to resultsEffect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring rosiglitazone, Type 2 diabetes, intima media thickness, Insulin resistance
Eligibility Criteria
Inclusion criteria: insulin resistant syndrome or Type 2 Diabetes. Exclusion criteria: Use of >= 2 concomitant oral antihyperglycaemic agents within 3 months of study start. Initiation of anti-hypertensive or lipid lowering therapy <= 6 months prior to study start or who increased the dose 3 months prior to study start. Unstable or severe angina or congestive heart failure NYHA class i-iv, history of acute myocardial infarction or stroke within last 6 months. Any history of surgical intervention in the right carotid artery. Clinically significant hepatic disease. Creatinine clearance <40ml/min.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
study drug
Outcomes
Primary Outcome Measures
Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.
Secondary Outcome Measures
Plaque occurrence & stenosis within the right carotid artery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00306644
Brief Title
Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
Official Title
Effect of Rosiglitazone and Placebo on Carotid Intima Media Thickness in Patients With Insulin Resistance Syndrome and/or Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes.
Detailed Description
RAS Rosiglitazone and Atherosclerosis Study: A 1 year randomised, double-blind, parallel group, placebo controlled study to evaluate the efficacy of rosiglitazone on the progression of intima-media thickness in the carotid artery in subjects with insulin resistance syndrome and/or type 2 diabetes mellitus
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
rosiglitazone, Type 2 diabetes, intima media thickness, Insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
556 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
study drug
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Intervention Description
study drug
Primary Outcome Measure Information:
Title
Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Plaque occurrence & stenosis within the right carotid artery.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
insulin resistant syndrome or Type 2 Diabetes.
Exclusion criteria:
Use of >= 2 concomitant oral antihyperglycaemic agents within 3 months of study start.
Initiation of anti-hypertensive or lipid lowering therapy <= 6 months prior to study start or who increased the dose 3 months prior to study start.
Unstable or severe angina or congestive heart failure NYHA class i-iv, history of acute myocardial infarction or stroke within last 6 months.
Any history of surgical intervention in the right carotid artery.
Clinically significant hepatic disease.
Creatinine clearance <40ml/min.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
17305652
Citation
Hedblad B, Zambanini A, Nilsson P, Janzon L, Berglund G. Rosiglitazone and carotid IMT progression rate in a mixed cohort of patients with type 2 diabetes and the insulin resistance syndrome: main results from the Rosiglitazone Atherosclerosis Study. J Intern Med. 2007 Mar;261(3):293-305. doi: 10.1111/j.1365-2796.2007.01767.x.
Results Reference
result
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
49653/334
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
49653/334
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
49653/334
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
49653/334
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
49653/334
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
49653/334
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
49653/334
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
We'll reach out to this number within 24 hrs