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 a small molecule drug developed by Takeda Pharmaceutical Company Limited for the treatment of Type 2 Diabetes Mellitus. It is a DPP4 inhibitor that has been studied in a Phase 3 clinical trial in Japan. Trelagliptin is also known as Trelagliptin 25 mg.
Trelagliptin is used for the treatment of Type 2 Diabetes Mellitus. It is being developed for patients with this metabolic condition, including those with severe renal impairment or end-stage renal disease, as studied in its Phase 3 clinical trial.
Trelagliptin targets DPP4, also known as dipeptidyl peptidase-4. It acts as a DPP4 inhibitor, a class of small molecule drugs used in the management of Type 2 Diabetes Mellitus. By inhibiting DPP4, Trelagliptin modulates incretin hormones involved in glucose regulation.
Trelagliptin is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company responsible for the clinical development of this DPP4 inhibitor for Type 2 Diabetes Mellitus.
Trelagliptin is in Phase 3 clinical development. It is an investigational drug and has been evaluated in a completed Phase 3 trial. The development program includes a randomized, double-blind, controlled study in patients with Type 2 Diabetes Mellitus.
Trelagliptin has been studied in a Phase 3 clinical trial identified as NCT02512068. This trial was a randomized, double-blind, parallel-group, controlled study of Trelagliptin 25 mg in patients with Type 2 Diabetes Mellitus complicated by severe renal impairment or end-stage renal disease. The trial was conducted in Japan and has been completed, with 107 patients enrolled.