Phase 3 Type 2 Diabetes Trial, Completed NCT01042977 Sponsor: AstraZeneca 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 enrolled 482 people in the dapagliflozin (a diabetes medication) group and 483 people in the placebo (dummy pill) group — just under 1,000 participants in total. All participants had type 2 diabetes as well as existing heart or blood vessel disease. The trial ran for 24 weeks and was measuring changes in three main things: blood sugar control (using a measure called HbA1c, which reflects average blood sugar levels over roughly three months), body weight, and seated systolic blood pressure (the top number in a blood pressure reading). The reported data shows that, on average, HbA1c levels changed by −0.33 percentage points in the dapagliflozin group compared with +0.07 percentage points in the placebo group, from the start of the trial to week 24. For the second primary measure — the proportion of participants who met all three targets at once (a drop of at least 0.5 percentage points in HbA1c, at least 3% reduction in body weight, and at least 3 mmHg drop in systolic blood pressure) — the reported figures were 10.0% of participants in the dapagliflozin group versus 1.9% in the placebo group. On the secondary measures, average body weight changed by −2.53% in the dapagliflozin group versus −0.61% in the placebo group. Among participants who started with a body mass index of 27 or above, 18.4% in the dapagliflozin group versus 4.8% in the placebo group were reported to have lost 5% or more of their body weight. Seated systolic blood pressure at week 24 changed by an average of −2.70 mmHg in the dapagliflozin group compared with +0.32 mmHg in the placebo group. 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

NCT01042977
Completed Phase 3 🇦🇺 Australian site

Who may 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 might be able to join this trial:

  • You have been diagnosed with type 2 diabetes
  • You have been diagnosed with heart or cardiovascular disease
  • You have been taking diabetes medication continuously for at least 8 weeks before joining the trial

Who may not be able to join:

  • You have type 1 diabetes or a condition called diabetes insipidus (a different condition unrelated to blood sugar)
  • You are currently taking 3 or more diabetes medications by mouth, with or without insulin, or your diabetes is not well controlled
  • You have any serious health condition that could affect your safety or ability to take part in the study (confirm with trial site)

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 14 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Dr. Lawrence A Leiter, MD, Division of Endocrinology & Metabolism, St Michael's Hospital

Australian sites

Research Site, Blacktown, New South Wales
Research Site, Broadmeadow, New South Wales
Research Site, Hornsby, New South Wales
Research Site, Wollongong, New South Wales
Research Site, Carina Heights, Queensland
Research Site, Kippa-Ring, Queensland
Research Site, Adelaide, South Australia
Research Site, Bedford Park, South Australia
Research Site, Keswick, South Australia
Research Site, Box Hill, Victoria
Research Site, Heidelberg, Victoria
Research Site, Herston,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 March 2010
Est. completion
1 May 2011

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇩🇪 Germany 🇭🇺 Hungary 🇵🇱 Poland 🇺🇸 United States

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

Primary endpoints

Adjusted Mean Change in HbA1c Levels; Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit

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: 14 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