Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

An observational study of Type 2 Diabetes Mellitus and CV Risk, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Type 2 Diabetes Mellitus, CV Risk
How many people: 1,100 participants
Where: No sites listed yet
Study dates: Mar 2004to not given
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: Type 2 Diabetes Mellitus, CV Risk
Keywords: Type 2 diabetes, CV risk, rosiglitazone, AVANDIA
Medical subject headings: Diabetes Mellitus, Type 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004?

First posted1 Apr 2008 (estimated)
Study startMar 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 1,100 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00648284
Sponsor's protocol ID: 104243
Other IDs: Avandia OB
Status last verified: Oct 2008
First submitted: 27 Mar 2008
Last updated: 15 Oct 2008
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00648284
Acronym / sponsor ID: 104243
Conditions: Type 2 Diabetes Mellitus, CV Risk
Keywords: Type 2 diabetes, CV risk, rosiglitazone, AVANDIA
Study type: Observational
Recruitment status: Completed
Enrolment: 1,100 participants
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2004
First posted: 1 Apr 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Prospective

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials, MD study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus and CV Risk, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00648284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.