Last updated on June 2019

Phase 3 Alogliptin Pediatric Study

Brief description of study

This study will evaluate the efficacy and safety of alogliptin 25 mg once daily (QD) 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 in pediatric participants 10 to 17 years of age with type 2 diabetes mellitus (T2DM).

Detailed Study 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 type 2 diabetes mellitus (T2DM) and are experiencing inadequate glycemic control. This study will look at glycosylated hemoglobin (HbA1c) fluctuations in children who take alogliptin in addition to their background antidiabetic therapy.

The study will enroll approximately 200 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groupswhich will remain undisclosed to the patient 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 25mg but has no active ingredient (i.e. 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.

Clinical Study Identifier: NCT02856113

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