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Phase 3 Alogliptin Pediatric Study

NCT02856113 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2022-10-19

Study results available
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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).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Alogliptin Benzoate

Alogliptin benzoate tablets.

DRUG

Placebo

Alogliptin placebo-matching tablets.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-14
Primary Completion
2021-08-06
Completion
2022-02-14
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Israel
  • Italy
  • Mexico
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02856113 on ClinicalTrials.gov