Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYR-472 · 7 trials · 3 indications
Reported data is the number of participants reporting one or more TEAEs that occurred before start of Treatment Period II in Treatment Group I and Treatment Group II.
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).
| Arm | Type | Description |
|---|---|---|
| Treatment Group I | EXPERIMENTAL | One tablet of SYR-472 100 mg orally once weekly before breakfast |
| Treatment Group II | EXPERIMENTAL | One tablet of SYR-472 100 mg orally or one placebo tablet orally once weekly before breakfast |
| 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) |
| Group A | EXPERIMENTAL | Participants in group A will be orally administered 2 tablets of SYR-472 25 mg in period 1 and 1 tablet of SYR-472 50 mg tablet in period 2, both in a single dose under fasting conditions in the morning. |
| Group B | EXPERIMENTAL | Participants in group B will be orally administered 1 tablet of SYR-472 50 mg in period 1 and 2 tablets of SYR-472 25 mg tablets in period 2, both in a single dose under fasting conditions in the morning. |
| Name | Type | Description |
|---|---|---|
| SYR-472 | DRUG | SYR-472 tablets |
| Placebo | DRUG | Placebo tablets |
| Alogliptin 25 mg | 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: Participant eligibility is determined according to the following criteria: 1. The participant has a diagnosis of type 2 diabetes mellitus. 2. The participant has a fasting C-peptide level of 0.6 ng/mL or higher at the start of the screening period (Week -6) and Week -2 of the s...
SYR-472 is an investigational small molecule being developed for Type 2 Diabetes Mellitus. It has been studied in clinical trials for the treatment of diabetes mellitus, including in combination with insulin in patients with Type 2 Diabetes. The drug is in Phase 3 development.
SYR-472 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has conducted multiple clinical trials of SYR-472 across Phase 1, Phase 2, and Phase 3 stages.
SYR-472 is in Phase 3 clinical development. It has completed five trials, including Phase 1, Phase 2, and Phase 3 studies. The drug is investigational and has not been reported as FDA approved.
SYR-472 has completed five clinical trials, including NCT00653185 and NCT00760344 in Phase 2 for Type 2 Diabetes, NCT02324569 in Phase 3 with insulin, and NCT02372097 in Phase 1 for healthy volunteers. All trials are completed.
No alternative names for SYR-472 have been reported. The drug is identified solely as SYR-472 in clinical trial records and development information from Takeda Pharmaceutical Company Limited.