CClinicalTrials.gg
CompletedNCT00648284Updated Oct 15, 2008

Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

An observational study in Type 2 Diabetes Mellitus and CV Risk, sponsored by GlaxoSmithKline. Completed. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-10-15.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
1,100
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • CV Risk

Keywords

  • Type 2 diabetes
  • CV risk
  • rosiglitazone
  • AVANDIA
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,100 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Time perspective
Prospective
Enrollment
1,100 participants
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00648284
Lead sponsor
GlaxoSmithKline
First posted
Apr 1, 2008
Start date
Mar 2004
Last update
Oct 15, 2008

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion