Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYR-472 · 6 trials · 2 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) |
| 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 developed for the treatment of type 2 diabetes mellitus. It has been studied as a treatment for patients with Diabetes Mellitus and Type 2 Diabetes Mellitus, including use in combination with insulin. It is being developed by Takeda Pharmaceutical Company Limited.
SYR-472 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the clinical trial program evaluating SYR-472 in patients with type 2 diabetes mellitus, including studies conducted in Japan.
SYR-472 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Five clinical trials of SYR-472 have been completed, with a total enrollment of 1,694 participants across the program.
SYR-472 has been evaluated in five completed clinical trials, including NCT02324569, a Phase 4 randomized, double-blind study of SYR-472 100 mg in combination with insulin in type 2 diabetes patients in Japan. Other trials include NCT01751360, NCT01632007, and NCT01431807, all completed Phase 3 studies.
Across the five completed SYR-472 clinical trials, a total of 1,694 participants were enrolled. The largest study, NCT01431807, a long-term Phase 3 study, enrolled 680 patients. All trials were conducted in Japan and enrolled patients aged 20 years and older.
SYR-472 trials have been randomized, double-blind, and placebo-controlled Phase 3 studies, along with open-label and long-term studies. The program includes NCT02324569, NCT01751360, NCT01632007, and NCT01431807, all completed, evaluating SYR-472 in patients with Diabetes Mellitus and Type 2 Diabetes Mellitus in Japan.