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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

556

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline

Completed

Started May 2002

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

May 1, 2002

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed

Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

March 22, 2006

Last Update Submit

August 31, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

rosiglitazoneType 2 diabetesintima media thicknessInsulin resistance

Outcome Measures

Primary Outcomes (1)

Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.
52 weeks

Secondary Outcomes (1)

Plaque occurrence & stenosis within the right carotid artery.
52 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

study drug

Drug: Rosiglitazone

Interventions

RosiglitazoneDRUG

study drug

Arm 1

Eligibility Criteria

Age35 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

insulin resistant syndrome or Type 2 Diabetes.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

GlaxoSmithKlinelead

Study Sites (1)

GSK Investigational Site

Malmo, SE-205 02, Sweden

Location

Related Publications (1)

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.
PMID: 17305652RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

GSK Clinical Trials
GlaxoSmithKline
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 24, 2006

Study Start

May 1, 2002

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

September 1, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing: Will share

Locations

SE(1)

Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Arm 1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Available IPD Datasets

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Arm 1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Available IPD Datasets

Locations