NCT02856113

Phase 3 Alogliptin Pediatric Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat children 10 to 17 years of age who have T2DM and are experiencing inadequate glycemic control. This study will look at HbA1c fluctuations in children who take alogliptin in addition to their background antidiabetic therapy. The study will enroll approximately 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Alogliptin 25 mg * Placebo (dummy inactive pill) - this is a tablet that looks like the tablet containing alogliptin 25 mg but has no active ingredient (that is, has no alogliptin). All participants will be asked to take one tablet at the same time each day throughout the study in addition to their current background antidiabetic therapy (metformin and/or insulin) if applicable. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 56 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 2 weeks after the last dose of study drug for a follow-up assessment.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Alogliptin Benzoate	Alogliptin benzoate tablets.
DRUG	Placebo	Alogliptin placebo-matching tablets.

Timeline

• Start date: 2016-10-14
• Primary completion: 2021-08-06
• Completion: 2022-02-14
• First posted: 2016-08-04
• Last updated: 2022-10-19
• Results posted: 2022-10-19

Locations

67 sites across 7 countries: United States, Brazil, Israel, Italy, Mexico, Poland, Russia

Regulatory

• FDA-regulated drug study