Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00306644 |
Recruitment Status
:
Completed
First Posted
: March 24, 2006
Last Update Posted
: September 1, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Rosiglitazone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 556 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Rosiglitazone and Placebo on Carotid Intima Media Thickness in Patients With Insulin Resistance Syndrome and/or Type 2 Diabetes |
Study Start Date : | May 2002 |
Actual Primary Completion Date : | November 2004 |
Actual Study Completion Date : | November 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
study drug
|
Drug: Rosiglitazone
study drug
|
- Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment. [ Time Frame: 52 weeks ]
- Plaque occurrence & stenosis within the right carotid artery. [ Time Frame: 52 weeks ]

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Ages Eligible for Study: | 35 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306644
Sweden | |
GSK Investigational Site | |
Malmö, Sweden, SE-205 02 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications of Results:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00306644 History of Changes |
Other Study ID Numbers: |
49653/334 |
First Posted: | March 24, 2006 Key Record Dates |
Last Update Posted: | September 1, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Keywords provided by GlaxoSmithKline:
rosiglitazone Type 2 diabetes intima media thickness Insulin resistance |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Metabolic Syndrome X Glucose Metabolism Disorders Metabolic Diseases |
Insulin Endocrine System Diseases Hyperinsulinism Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs |