Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

NCT ID: NCT00648284

Last Updated: 2008-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus CV Risk

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Type 2 diabetes CV risk rosiglitazone AVANDIA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GSK

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

Review the countries where the study has at least one active or historical site.

Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Avandia OB

Identifier Type: -

Identifier Source: secondary_id

104243

Identifier Type: -

Identifier Source: org_study_id