Phase 4 Type 2 Diabetes Trial, Completed NCT01989754 Sponsor: Janssen Research & Development, LLC 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 (NCT01989754) enrolled 5,812 people in total — 2,905 in the placebo group and 2,907 in the canagliflozin group. The vast majority completed the study (around 2,866 and 2,872 in each group respectively). The trial was measuring kidney-related and heart-related outcomes in people with type 2 diabetes, specifically looking at whether their levels of a protein called albumin in the urine worsened over time, and whether they experienced heart-related deaths or hospital admissions for heart failure. The reported data shows the following numbers for the primary outcome — worsening of albumin in the urine (a marker of kidney stress). In the placebo group, there were approximately 153 such events per 1,000 patient-years (a way of counting events that accounts for how long people were followed), compared with approximately 100 events per 1,000 patient-years in the canagliflozin group. For the secondary outcomes, the combined rate of cardiovascular (heart-related) death or hospitalisation for heart failure was reported as about 21.9 events per 1,000 patient-years in the placebo group versus about 15.9 in the canagliflozin group. For cardiovascular death alone, the reported rates were about 11.6 per 1,000 patient-years in the placebo group and about 10.1 per 1,000 patient-years in the canagliflozin group. These figures are event rates as counted and submitted by the trial's sponsor, and no further statistical detail (such as confidence intervals or p-values) was included in the data provided here. 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 4 Type 2 Diabetes Trial, Completed

NCT01989754
Completed Phase 4 🇦🇺 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.
  • Your blood sugar is not well controlled, meaning a recent blood test (called an HbA1c) showed a result between 7.0% and 10.5%.
  • You are 30 years of age or older with a history of a heart or blood vessel problem, OR you are 50 years of age or older with a high risk of developing heart or blood vessel problems.
  • You are either not currently taking any diabetes medications, or you are taking one or more approved diabetes medications to help control your blood sugar.

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 have a history of a serious diabetes complication called diabetic ketoacidosis, type 1 diabetes, a pancreas or insulin-cell transplant, or diabetes caused by a pancreas condition or surgery.
  • You have had one or more severe low blood sugar episodes in the 6 months before joining the study.
  • You have a rare inherited condition affecting how your body processes certain sugars (confirm with trial site).
  • You have a thyroid condition that is not well controlled.
  • You have serious kidney disease that required immune-suppressing treatment, or you have a history of long-term dialysis or a kidney transplant.
  • You have had a heart attack, severe chest pain, a heart or blood vessel procedure, or a stroke within the 3 months before joining the study.

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 30 June 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
16 January 2014
Est. completion
23 February 2017

Where this trial was run

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland Puerto Rico 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 12 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Progression of Albuminuria

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: 30 June 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