Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00648284
First received: March 27, 2008
Last updated: October 13, 2008
Last verified: October 2008
  Purpose

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.


Condition
Type 2 Diabetes Mellitus
CV Risk

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Observational Study to Assess the Impact of Pharmacological Intervention and Life Style Changes in the Reduction of Cardiovascular Disease in Patients With Diabetes Type 2 in Greece

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 1100
Study Start Date: March 2004
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648284

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00648284     History of Changes
Other Study ID Numbers: 104243, Avandia OB
Study First Received: March 27, 2008
Last Updated: October 13, 2008
Health Authority: Greece: National Organization of Medicines

Keywords provided by GlaxoSmithKline:
Type 2 diabetes
CV risk
rosiglitazone
AVANDIA

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014