Phase 3 Alogliptin Pediatric Study

Summary

The primary purpose of this study is to evaluate the efficacy of alogliptin 25 milligram (mg) once daily compared to placebo when administered as monotherapy, or when added onto a background of metformin alone, insulin alone, or a combination of metformin and insulin, as measured by the glycosylated hemoglobin (HbA1c) change from Baseline at Week 26 in pediatric participants with type 2 diabetes mellitus (T2DM).

Timeline

Start

2016-10-14

Primary completion

2021-08-06

Completion

2022-02-14

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Alogliptin 25 mg; p =0.782; Least Square (LS) Mean Difference 0.102 (95% CI -0.627 to 0.831); NCT02856113 ↗

paper Alogliptin 25 mg QD did not significantly improve glycemic control versus placebo in pediatric patients with T2DM. PMID 40032809 ↗

Publications

• Peng XV, Klingensmith G, Hsia DS, Xie Y, Czerniak R, Tamborlane WV, Shah AS. A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus. Diabetes Ther. 2025 May;16(5):865-883. doi: 10.1007/s13300-025-01700-3. Epub 2025 Mar 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogliptin	Unknown	25 mg	Oral

Indications