Phase 3 Type 2 Diabetes Trial, Completed NCT00379769 Sponsor: GlaxoSmithKline Condition: Type 2 Diabetes
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial involved people with type 2 diabetes who were already taking one of two common diabetes medicines — metformin or a sulphonylurea — and were then randomly assigned to add a second medicine to their treatment. The four treatment groups compared adding rosiglitazone (RSG) or a sulphonylurea (SU) to metformin, and adding rosiglitazone or metformin to a sulphonylurea. Across the four groups, roughly 1,100 people started in each, giving a total of about 4,447 participants in the main study phase. A later observational follow-up phase tracked approximately 2,530 of those participants (grouped into a combined RSG group and a combined comparison group) without any change to their treatment. The reported data shows that the main thing the trial was measuring was how many people in each broad treatment group experienced either a hospitalisation for a heart or blood vessel problem, or a death from a cardiovascular (heart/blood vessel) cause. According to the results reported on ClinicalTrials.gov, 321 participants in the combined RSG group and 323 participants in the combined comparison group (those who had added metformin or sulphonylurea) had one of these events. For secondary measures — which looked at a wider range of events including heart attacks, strokes, heart failure, and deaths from any cause — the reported numbers were broadly similar between the two broad groups. For example, 154 participants in the combined RSG group and 165 in the comparison group had a heart attack or cardiovascular death; 171 versus 184 died from any cause. One notable secondary measure was blood sugar control: far fewer participants in the rosiglitazone-added groups (281 and 365, depending on the background medicine) had their blood sugar levels rise to the point of being classified as a treatment failure, compared with the comparison groups (451 and 424 respectively). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Type 2 Diabetes Trial, Completed

NCT00379769
Completed Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • 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

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026

Trial contact details on record

Principal Investigator: GSK Clinical Trials, GlaxoSmithKline

Australian sites

GSK Investigational Site, Miranda, New South Wales
GSK Investigational Site, Randwick, New South Wales
GSK Investigational Site, Wollongong, New South Wales
GSK Investigational Site, Carina Heights, Queensland
GSK Investigational Site, Kippa-Ring, Queensland
GSK Investigational Site, Sherwood, Queensland
GSK Investigational Site, Keswick, South Australia
GSK Investigational Site, North Adelaide, South Australia
GSK Investigational Site, Port Lincoln, South Australia
GSK Investigational Site, Heidelberg, Victoria
GSK Investigational Site, Malvern, Victoria

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

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Trial details

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

Where this trial was run

🇦🇺 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

These are the locations recorded on the registry, including 11 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

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...

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov