Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trelagliptin · 1 trial · 1 indication
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Reported data is the number of participants reporting one or more TEAEs that occurred before the start of Treatment Period II in each group.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. As to collect the safety data of long-term treatment with the active drug widely, the number of participants reporting one or more TEAEs that occurred after 1st dose of trelagliptin 25 mg, that is events in Period I and II for "Trelagliptin 25 mg" group and events in Period II for "Placebo and Trelagliptin 25 mg" group, was analyzed.
| Arm | Type | Description |
|---|---|---|
| Trelagliptin 25 mg | EXPERIMENTAL | Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II) |
| Placebo and Trelagliptin 25 mg | EXPERIMENTAL | Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II) |
| Name | Type | Description |
|---|---|---|
| Trelagliptin 25 mg | DRUG | Trelagliptin 25 mg Tablets |
| Placebo | DRUG | Placebo Tablets |
Inclusion Criteria: 1. The participant has a diagnosis of type 2 diabetes mellitus. 2. The participant has a fasting C-peptide value of 0.6 ng/mL or higher at the start of the screening period (Week -6) and Week -2 of the screening period. 3. The participant has a hemoglobin value of 10.0 g/dL or h...
Trelagliptin is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with Type 2 Diabetes Mellitus complicated by severe renal impairment or end-stage renal disease.
Trelagliptin is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus, particularly those with severe renal impairment or end-stage renal disease.
Trelagliptin is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The Phase 3 program includes a randomized, double-blind, parallel-group comparative study and a long-term open-label study in patients with Type 2 Diabetes Mellitus complicated by severe renal impairment or end-stage renal disease.
Trelagliptin has one completed Phase 3 clinical trial registered as NCT02512068. This trial was a randomized, double-blind, parallel-group comparative study and a multicenter, open-label, long-term study of SYR-472 (25 mg) in patients with Type 2 Diabetes Mellitus complicated by severe renal impairment or end-stage renal disease. The trial enrolled 107 participants in Japan.
Yes, Trelagliptin is also known as SYR-472. In the clinical trial NCT02512068, the drug is referred to as SYR-472, and it is being studied at a dose of 25 mg in patients with Type 2 Diabetes Mellitus complicated by severe renal impairment or end-stage renal disease.