NCT00648284

Brief Summary

The primary objective of this study is to assess the total CV risk in patients with type 2 diabetes and also to assess the impact of rosiglitazone in the total CV risk and the parameters of metabolic syndrome.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for all trials

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

Study Start

First participant enrolled

March 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

October 15, 2008

Status Verified

October 1, 2008

First QC Date

March 27, 2008

Last Update Submit

October 13, 2008

Conditions

Type 2 Diabetes MellitusCV Risk

Keywords

Type 2 diabetesCV riskrosiglitazoneAVANDIA

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diabetes type 2 that their physician has decided to prescribe AVANDIA for better control of their condition
  • Have signed informed consent

You may not qualify if:

  • Patients with ALT \> 2.5x the normal value
  • With heart failure symptoms
  • With diagnosis of angina pectoris or stable angina demanding continuous treatment with nitrates
  • With recent myocardial infarction (\<6 months)
  • With severe renal disfunction
  • Pregnant or lactating or planned to be pregnant during the study
  • Under investigational drug treatment
  • Alcoholic or drug abuser

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

March 1, 2004

Last Updated

October 15, 2008

Record last verified: 2008-10