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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01751360 | SYR-472 Open-label Study | PHASE3 | COMPLETED | 14 | — | — | Apr 1, 2013 | Aug 1, 2013 | Dec 11, 2023 | 1 | Japan |
| NCT01632007 | Double-blind Comparative Study of SYR-472 | PHASE3 | COMPLETED | 245 | — | — | May 1, 2012 | Jul 1, 2013 | Dec 11, 2023 | 22 | Japan |
| NCT01431807 | Long-term Study of SYR-472 | PHASE3 | COMPLETED | 680 | — | — | Sep 1, 2011 | Jun 1, 2013 | Dec 14, 2023 | 41 | Japan |
| NCT00653185 | Efficacy of SYR-472 in Subjects With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 369 | — | — | May 1, 2007 | Mar 1, 2008 | Jun 22, 2016 | 87 | United States, Chile +10 |
| NCT00760344 | Efficacy and Safety of SYR-472 in Subjects With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 386 | — | — | Mar 1, 2007 | Mar 1, 2008 | Jun 22, 2016 | 112 | United States, Mexico |
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).
| Arm | Type | Description |
|---|---|---|
| SYR-472 100mg | EXPERIMENTAL | SYR-472 100mg |
| SYR-472 100 mg | EXPERIMENTAL | - |
| Alogliptin 25 mg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| SYR-472 group | EXPERIMENTAL | (long-term monotherapy or long-term combination therapy with anti-diabetic drugs) |
| SYR-472 25 mg QD | EXPERIMENTAL | (with lifestyle modification and/or metformin therapy) |
| SYR-472 50 mg QD | EXPERIMENTAL | (with lifestyle modification and/or metformin therapy) |
| SYR-472 100 mg QD | EXPERIMENTAL | (with lifestyle modification and/or metformin therapy) |
| SYR-472 200 mg QD | EXPERIMENTAL | (with lifestyle modification and/or metformin therapy) |
| Placebo QD | PLACEBO_COMPARATOR | (with lifestyle modification and/or metformin therapy) |
| SYR-472 3.125 mg QD | EXPERIMENTAL | (with lifestyle modification and/or metformin stable dose therapy) |
| SYR-472 12.5 mg QD | EXPERIMENTAL | (with lifestyle modification and/or metformin stable dose therapy) |
| Sitagliptin 100 mg QD | ACTIVE_COMPARATOR | (with lifestyle modification and/or metformin stable dose therapy) |
| Name | Type | Description |
|---|---|---|
| SYR-472 | DRUG | - |
| Alogliptin 25 mg | DRUG | - |
| Placebo | DRUG | - |
| Sitagliptin | DRUG | Sitagliptin 100 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks. |
Inclusion Criteria: -1. The participant is judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator. 2\. The participant can sign and date a written, informed consent form prior to the initiation of any study procedures. Exclusion Crite...