Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01137812 | The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial) | PHASE3 | COMPLETED | 756 | — | — | Jul 1, 2010 | Mar 1, 2012 | Jan 15, 2015 | 184 | United States, Austria +15 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.
| Arm | Type | Description |
|---|---|---|
| Canagliflozin 300 mg | EXPERIMENTAL | Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea |
| Sitagliptin 100 mg | ACTIVE_COMPARATOR | Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea |
| Name | Type | Description |
|---|---|---|
| Sitagliptin 100 mg | DRUG | One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea |
| Canagliflozin 300 mg | DRUG | One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea |
| Metformin | DRUG | Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study. |
| Sulphonylurea | DRUG | Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study. |
Inclusion Criteria: * All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea * Patients in the study must have a HbA1c between \>=7 and \<=10.5% and a fasting plasma glucose (FPG) \<300 mg/dL (16.7 mmol/L) Exclusion Criteria: * History of diabetic ket...