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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00379769

NCT00379769
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Type 2 diabetes, as defined by World Health Organisation guidelines.
  • Your blood sugar control level (measured by an HbA1c blood test) is between 7.0% and 9.0% at your first visit.
  • You have been taking a tablet or pill to help manage your blood sugar for at least 6 months, and that medication has not changed in the last 2 months.
  • Your body mass index (BMI), which is a measure of body weight relative to height, is above 25.0.

Who may not be able to join:

  • You are currently taking any blood sugar lowering medication other than metformin or a sulfonylurea (a common type of diabetes tablet).
  • Your blood pressure is very high — specifically, the top number is above 180 or the bottom number is above 105 (confirm with trial site).
  • You have ever needed to use insulin injections at any point in the past to control your blood sugar.
  • You have been admitted to hospital for a serious heart or blood vessel related event in the last 3 months.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
GlaxoSmithKline
Registry
clinicaltrials_gov
Start date
1 April 2001
Est. completion
1 December 2008

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇬 Bulgaria 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇸🇰 Slovakia 🇪🇸 Spain 🇸🇪 Sweden 🇺🇦 Ukraine 🇬🇧 United Kingdom

11 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events; Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause; Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions; Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fata...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov