30 and older, any sex, with Diabetes Mellitus, Type 2 or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal StrokePrimary· Up to approximately 8 years
MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.
Group
Value
95% CI
Placebo
30.36
Canagliflozin 100 mg
28.41
Canagliflozin 300 mg
25.37
Canagliflozin (Total)
26.89
Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)Secondary· Baseline and end of treatment (approximately 338 weeks)
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent.
Group
Value
95% CI
Placebo
4.02
± 1.611
Canagliflozin 100 mg
6.82
± 1.533
Canagliflozin 300 mg
8.09
± 1.587
Percentage of Participants With Progression of Albuminuria at the End-of-TreatmentSecondary· End of treatment (approximately 338 weeks)
Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to \[\>=\] 30 milligram per gram (mg/g) and less than or equal to \<= 300 mg/g) or macroalbuminuria (ACR of \>300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed.
Group
Value
95% CI
Placebo
24.0
Canagliflozin 100 mg
20.2
Canagliflozin 300 mg
18.3
Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-TreatmentSecondary· Baseline and end of treatment (approximately 338 weeks)
A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.
Group
Value
95% CI
Placebo
0.70
± 0.150
Canagliflozin 100 mg
0.67
± 0.140
Canagliflozin 300 mg
1.03
± 0.142
Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-TreatmentSecondary· Baseline and End of treatment (approximately 338 weeks)
Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine.
Group
Value
95% CI
Placebo
29.30
27.66 – 31.03
Canagliflozin 100 mg
25.50
24.09 – 27
Canagliflozin 300 mg
24.47
23.11 – 25.91
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-TreatmentSecondary· Baseline and end of treatment (approximately 338 weeks)
Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m\^2) = 175 \* (serum creatinine) \^ 1.154 \* (Age) \^-0.203 \*(0.742 if female) \* (1.21 if Black).
Group
Value
95% CI
Placebo
-5.23
± 0.390
Canagliflozin 100 mg
-3.55
± 0.388
Canagliflozin 300 mg
-3.98
± 0.392
Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-TreatmentSecondary· Baseline and end of treatment (approximately 338 weeks)
Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood.
Group
Value
95% CI
Placebo
0.01
± 0.032
Canagliflozin 100 mg
-0.26
± 0.032
Canagliflozin 300 mg
-0.31
± 0.032
Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-TreatmentSecondary· Baseline and end of treatment (approximately 338 weeks)
Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed.
Group
Value
95% CI
Placebo
0.16
± 0.076
Canagliflozin 100 mg
-0.42
± 0.075
Canagliflozin 300 mg
-0.57
± 0.076
Percent Change From Baseline in Body Weight at End-of-TreatmentSecondary· Baseline and end of treatment (approximately 338 weeks)
Percent change from baseline in body weight was assessed at the end of treatment.
Group
Value
95% CI
Placebo
-0.50
± 0.184
Canagliflozin 100 mg
-3.47
± 0.183
Canagliflozin 300 mg
-4.12
± 0.185
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-TreatmentSecondary· Baseline and end of treatment (approximately 338 weeks)
Change from baseline in systolic blood pressure and diastolic blood pressure was assessed.
SBP(Change at end of treatment)
Group
Value
95% CI
Placebo
-1.96
± 0.377
Canagliflozin 100 mg
-4.91
± 0.375
Canagliflozin 300 mg
-6.49
± 0.378
DBP (Change at end of treatment)
Group
Value
95% CI
Placebo
-2.88
± 0.223
Canagliflozin 100 mg
-3.70
± 0.221
Canagliflozin 300 mg
-4.51
± 0.223
Change From Baseline in Triglycerides Levels at End-of-TreatmentSecondary· Baseline and end of treatment (approximately 338 weeks)
Change from baseline in triglycerides levels was assessed.
Group
Value
95% CI
Placebo
0.05
± 1.597
Canagliflozin 100 mg
0.13
± 1.679
Canagliflozin 300 mg
0.09
± 1.238
Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-TreatmentSecondary· Baseline and end of treatment (approximately 338 weeks)
Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed.
Cholesterol (change at EOT)
Group
Value
95% CI
Placebo
-0.07
± 0.028
Canagliflozin 100 mg
0.11
± 0.027
Canagliflozin 300 mg
0.16
± 0.028
HDL-C (change at EOT)
Group
Value
95% CI
Placebo
-0.01
± 0.006
Canagliflozin 100 mg
0.04
± 0.006
Canagliflozin 300 mg
0.05
± 0.006
LDL-C (change at EOT)
Group
Value
95% CI
Placebo
-0.07
± 0.022
Canagliflozin 100 mg
0.04
± 0.022
Canagliflozin 300 mg
0.10
± 0.023
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately 8 years.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.
The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2
· Phase 2
· recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part
· recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use
· NA
· recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
· Phase 1
· recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0
· recruiting
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 3
· not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC
· recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
· Phase 3
· not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
· Phase 3
· recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
· Phase 1, PHASE2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 7 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01032629.