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Label indication Alogliptin and metformin HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin and metformin HCl tablets are a combination of alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes… FDA label
Also known as SYR-322, Nesina, Vipidia
Alogliptin Benzoate · 1 trial · 1 indication
Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Week 26 relative to Baseline. Mixed model for repeated measures (MMRM) was used for the analysis.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Alogliptin matching-placebo tablets, orally, once daily (QD) for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period. |
| Alogliptin 25 mg | EXPERIMENTAL | Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period. |
| Name | Type | Description |
|---|---|---|
| Alogliptin Benzoate | DRUG | Alogliptin benzoate tablets. |
| Placebo | DRUG | Alogliptin placebo-matching tablets. |
Inclusion Criteria: 1. Has a confirmed diagnosis of T2DM using American Diabetes Association (ADA) and World Health Organization (WHO) criteria (laboratory determinations of fasting plasma glucose \[FPG\] greater than or equal to \[\>=\] 126 mg/dL, random glucose \>=200 mg/dL \[\>=11.10 mmol/L\], H...
Alogliptin Benzoate 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 pediatric trial. The drug is designed to improve glycemic control in patients with this metabolic condition.
Alogliptin Benzoate is used for the treatment of type 2 diabetes mellitus. It is a DPP4 inhibitor small molecule developed by Takeda Pharmaceutical Company Limited. The drug has been evaluated in a Phase 3 clinical trial specifically for pediatric patients with type 2 diabetes, aged 10 years and older.
Alogliptin Benzoate targets DPP4, also known as dipeptidyl peptidase-4. It acts as a DPP4 inhibitor. By inhibiting this enzyme, the drug modulates incretin hormones involved in glucose regulation. This mechanism supports its use in managing type 2 diabetes mellitus.
Alogliptin Benzoate is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical development program for this DPP4 inhibitor small molecule, including the Phase 3 pediatric study conducted in multiple countries.
Alogliptin Benzoate is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The completed study was a randomized, double-blind, placebo-controlled trial evaluating the drug in pediatric patients with type 2 diabetes mellitus.
Alogliptin Benzoate has been studied in a Phase 3 trial identified as NCT02856113, titled Phase 3 Alogliptin Pediatric Study. This completed trial enrolled 152 participants with type 2 diabetes mellitus across the United States, Brazil, Israel, Italy, Mexico, Poland, and Russia. It was randomized, double-blind, and placebo-controlled.