Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02856113 | Phase 3 Alogliptin Pediatric Study | PHASE3 | COMPLETED | 152 | — | — | Oct 14, 2016 | Feb 14, 2022 | Oct 19, 2022 | 67 | United States, Brazil +5 |
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...