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Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

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ClinicalTrials.gov Identifier: NCT00648284
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : October 15, 2008
Sponsor:
Information provided by:
GlaxoSmithKline

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.

Condition or disease
Type 2 Diabetes Mellitus CV Risk

Study Type : Observational
Enrollment : 1100 participants
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
Study Start Date : March 2004

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00648284


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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00648284     History of Changes
Other Study ID Numbers: 104243
Avandia OB
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008

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

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