Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00968812 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 52 Day 1 (Baseline) and Week 52 | Canagliflozin 100 mg | -0.82 Percent (±0.039 Standard Error) |
| Canagliflozin 300 mg | -0.93 Percent (±0.039 Standard Error) | |||
| Glimepiride | -0.81 Percent (±0.039 Standard Error) | |||
| NCT01032629 CANVAS | Diabetes Mellitus, Type 2 | Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke Up to approximately 8 years | Canagliflozin (Total) | 26.89 Events per 1000 patient-year |
| Canagliflozin 100 mg | 28.41 Events per 1000 patient-year | |||
| Canagliflozin 300 mg | 25.37 Events per 1000 patient-year | |||
| Placebo | 30.36 Events per 1000 patient-year | |||
| NCT01064414 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 26 Day 1 (Baseline) and Week 26 | Canagliflozin 100 mg | -0.33 Percent (±0.090 Standard Error) |
| Canagliflozin 300 mg | -0.44 Percent (±0.089 Standard Error) | |||
| Placebo | -0.03 Percent (±0.090 Standard Error) | |||
| NCT01081834 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy) Day 1 (Baseline) and Week 26 | Canagliflozin 100 mg | -2.13 Percent (±0.220 Standard Error) |
| Canagliflozin 300 mg | -2.56 Percent (±0.227 Standard Error) | |||
| NCT01081834 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 26 (Main Study) Day 1 (Baseline) and Week 26 | Canagliflozin 100 mg | -0.77 Percent (±0.065 Standard Error) |
| Canagliflozin 300 mg | -1.03 Percent (±0.064 Standard Error) | |||
| Placebo | 0.14 Percent (±0.065 Standard Error) | |||
| NCT01106625 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 26 Day 1 (Baseline) and Week 26 | Canagliflozin 100 mg | -0.85 Percent (±0.075 Standard Error) |
| Canagliflozin 300 mg | -1.06 Percent (±0.076 Standard Error) | |||
| Placebo | -0.13 Percent (±0.075 Standard Error) | |||
| NCT01106651 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 26 Day 1 (Baseline) and Week 26 | Canagliflozin 100 mg | -0.60 Percent (±0.063 Standard Error) |
| Canagliflozin 300 mg | -0.73 Percent (±0.064 Standard Error) | |||
| Placebo | -0.03 Percent (±0.063 Standard Error) | |||
| NCT01106677 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 26 Day 1 (Baseline) and Week 26 | Canagliflozin 100 mg | -0.79 Percent (±0.044 Standard Error) |
| Canagliflozin 300 mg | -0.94 Percent (±0.044 Standard Error) | |||
| Placebo/Sitagliptin | -0.17 Percent (±0.060 Standard Error) | |||
| Sitagliptin 100 mg | -0.82 Percent (±0.044 Standard Error) | |||
| NCT01106690 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 26 Day 1 (Baseline) and Week 26 | Canagliflozin 100 mg | -0.89 Percent (±0.069 Standard Error) |
| Canagliflozin 300 mg | -1.03 Percent (±0.070 Standard Error) | |||
| Placebo/Sitagliptin | -0.26 Percent (±0.069 Standard Error) | |||
| NCT01137812 | Diabetes Mellitus, Type 2 | Change in HbA1c From Baseline to Week 52 Day 1 (Baseline) and Week 52 | Canagliflozin 300 mg | -1.03 Percent (±0.048 Standard Error) |
| Sitagliptin 100 mg | -0.66 Percent (±0.049 Standard Error) | |||
| NCT01381900 | Diabetes Mellitus, Type 2 | Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18 Day 1 (Baseline) and Week 18 | Canagliflozin 100 mg | -0.97 Percent (±0.095 Standard Error) |
| Canagliflozin 300 mg | -1.06 Percent (±0.095 Standard Error) | |||
| Placebo | -0.47 Percent (±0.096 Standard Error) | |||
| NCT01809327 | Diabetes Mellitus, Type 2 | Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 Day 1 (Baseline) and Week 26 | Canagliflozin 100 mg + Metformin XR | -1.77 percentage of hemoglobin (±0.069 Standard Error) |
| Canagliflozin 100 Milligram (mg) | -1.37 percentage of hemoglobin (±0.071 Standard Error) | |||
| Canagliflozin 300 mg | -1.42 percentage of hemoglobin (±0.070 Standard Error) | |||
| Canagliflozin 300 mg + Metformin XR | -1.78 percentage of hemoglobin (±0.070 Standard Error) | |||
| Metformin XR | -1.30 percentage of hemoglobin (±0.071 Standard Error) | |||
| NCT02065791 CREDENCE | Diabetes Mellitus, Type 2 | Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death Up to 4.6 years | Canagliflozin 100 mg | 43.21 Event rate per 1000 participant-years |
| Placebo | 61.24 Event rate per 1000 participant-years | |||
| NCT02220907 | Diabetes Mellitus, Type 2 | Number of Participants With Adverse Events 52 Weeks | Teneligliptin+Canagliflozin | 11 participants |
| Teneligliptin+Canagliflozin | 107 participants | |||
| NCT02354222 | Diabetes Mellitus, Type 2 | Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) Baseline, 24 Weeks | Placebo+Canagliflozin | 0.00 percentage of HbA1c (±0.08 Standard Error) |
| Teneligliptin+Canagliflozin | -0.94 percentage of HbA1c (±0.08 Standard Error) | |||
| NCT02354235 | Diabetes Mellitus, Type 2 | Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) Baseline, 24 Weeks | Canagliflozin+Teneligliptin | -0.97 percentage of HbA1c (±0.10 Standard Error) |
| Placebo+Teneligliptin | -0.10 percentage of HbA1c (±0.10 Standard Error) | |||
| NCT03136484 SUSTAIN 8 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 52 | Canagliflozin + Semaglutide Placebo | -1.0 Percentage (%) of HbA1c (±1.1 Standard Deviation) |
| Canagliflozin + Semaglutide Placebo | -1.0 Percentage (%) of HbA1c (±1.0 Standard Deviation) | |||
| Semaglutide + Canagliflozin Placebo | -1.7 Percentage (%) of HbA1c (±1.1 Standard Deviation) | |||
| Semaglutide + Canagliflozin Placebo | -1.5 Percentage (%) of HbA1c (±1.3 Standard Deviation) | |||
| NCT03170518 | Diabetes Mellitus, Type 2 | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 Baseline (Day 1) and Week 26 | Canagliflozin 100/300 mg | -0.37 Percent (%) of HbA1c (±0.194 Standard Error) |
| Placebo | 0.39 Percent (%) of HbA1c (±0.191 Standard Error) | |||
| NCT03170518 | Diabetes Mellitus, Type 2 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56) | Canagliflozin 100 mg | 76.1 Percentage of participants |
| Canagliflozin 300 mg | 82.4 Percentage of participants | |||
| Placebo | 74.7 Percentage of participants | |||
| NCT03436693 | Diabetes Mellitus, Type 2 | Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104 Week 104 | Canagliflozin 100mg | 18.2 Percentage of Participants |
| Placebo | 29.5 Percentage of Participants | |||
| NCT04252287 CHIEF-HF | Heart Failure | Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12 Baseline, Week 12 | Canagliflozin 100 mg | 9.2 Score on a scale (±1.27 Standard Error) |
| Placebo | 4.9 Score on a scale (±1.27 Standard Error) |