At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 152 enrolled
Drug / intervention
Alogliptin Benzoate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Alogliptin Benzoate and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 152 participants across 67 sites in 7 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBrazil, Israel, Italy, Mexico, Poland, Russia, United States
CollaboratorsTakeda Development Center Americas, Inc.
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartOct 2016
Primary CompletionAug 2021
Study CompletionFeb 2022
TodayJul 2026
First PostedAug 4, 2016
Enrollment StartOct 14, 2016
Primary CompletionAug 6, 2021
Study CompletionFeb 14, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.9 years ago
Interventions
Alogliptin Benzoatedrug
Alogliptin benzoate tablets.
Placebodrug
Alogliptin placebo-matching tablets.