Phase 3 Type 2 Diabetes Trial, Completed NCT01106625 Sponsor: Janssen Research & Development, LLC Condition: Type 2 Diabetes
Back to Type 2 Diabetes

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 469 adults across three groups: 156 received a placebo (a dummy treatment with no active ingredient), 157 received a 100 mg daily dose of canagliflozin, and 156 received a 300 mg daily dose of canagliflozin. The trial ran in two stages — a 26-week core period and a further 26-week extension to week 52. The main thing being measured was the change in HbA1c (a blood test that reflects average blood sugar levels over roughly three months) from the start of the trial to week 26. A number of secondary measurements were also taken, including fasting blood sugar levels, body weight, blood pressure, and blood fats called triglycerides. The reported data shows that, by week 26, the average HbA1c change was −0.13% in the placebo group, −0.85% in the 100 mg canagliflozin group, and −1.06% in the 300 mg canagliflozin group. For the secondary outcomes, the proportion of participants whose HbA1c fell below 7% at week 26 was reported as 18% (placebo), 43.2% (100 mg), and 56.6% (300 mg). Fasting blood sugar changed by +4.11 mg/dL in the placebo group, −18.2 mg/dL in the 100 mg group, and −30.5 mg/dL in the 300 mg group. Body weight changed by −0.7%, −2.1%, and −2.6% respectively. Systolic blood pressure (the top number in a blood pressure reading) changed by −2.65 mmHg, −4.89 mmHg, and −4.27 mmHg. Triglyceride (a type of fat in the blood) levels changed by +11.6%, +5.4%, and +8.5% across the three groups. 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

NCT01106625
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 must have been diagnosed with type 2 diabetes and currently be taking two specific diabetes medications: metformin and a sulphonylurea (a type of diabetes pill).
  • Your HbA1c (a blood test showing average blood sugar levels over the past few months) must be between 7% and 10.5%.
  • Your fasting blood sugar level (measured after not eating) must be below 270 mg/dL (15 mmol/L).

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 may not be eligible if you have a history of a serious diabetes complication called diabetic ketoacidosis, type 1 diabetes, a pancreas or beta cell transplant, diabetes caused by a pancreas condition or surgery, or if you have had a severe low blood sugar episode in the 6 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 1 July 2026

GP referral letter

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

Trial details

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

Where this trial was run

🇦🇺 Australia 🇧🇪 Belgium 🇫🇷 France Guatemala 🇭🇺 Hungary 🇮🇱 Israel 🇲🇽 Mexico Puerto Rico 🇷🇺 Russia 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 5 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Change in HbA1c From Baseline to Week 26

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: 1 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