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Completed Phase 3 Interventional Results available

Phase 3 Alogliptin Pediatric Study

ClinicalTrials.gov ID: NCT02856113

Public ClinicalTrials.gov record NCT02856113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02856113
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
152 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 13, 2016
Primary completion
Aug 5, 2021
Completion
Feb 13, 2022
Last update posted
Oct 18, 2022

2016 – 2022

United States locations

U.S. sites
34
U.S. states
24
U.S. cities
34
Facility City State ZIP Site status
Arkansas Children's Hospital Research Institute Little Rock Arkansas 72202
Children's Hospital Los Angeles Los Angeles California 90027
Sherif Khamis Palmdale California 93550
Lucile Packard Children's Hospital at Stanford University Palo Alto California 94304
Touro University California Vallejo California 94592
Yale New Haven Hospital New Haven Connecticut 06511
Children's National Health System Washington D.C. District of Columbia 20010
University of Florida Gainesville Florida 32610
Nemours Childrens Specialty Care - Jacksonville Jacksonville Florida 32207
Baptist Diabetes Associates Research Miami Florida 33156
University of South Florida/USF Health Tampa Florida 33612
Endocrine Consultants Research Columbus Georgia 31904
Endocrine Consultants Research - Oak Hill Court Newnan Georgia 30265
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611
Indiana University Indianapolis Indiana 46202
University of Iowa Iowa City Iowa 52242
University of Kentucky Health Care Lexington Kentucky 40504
Pennington Biomedical Research Center Baton Rouge Louisiana 70808
Ochsner Baptist Medical Center New Orleans Louisiana 70115
University of Minnesota Masonic Children's Hospital - Pediatric Specialty Care Discovery Clinic Minneapolis Minnesota 55454
Gulfside Clinical Research Gulfport Mississippi 39501
Saint Louis University St Louis Missouri 63104
Horizon View Medical Center Las Vegas Nevada 89149
Saint Joseph's Regional Medical Center - Paterson Paterson New Jersey 07503
University of Rochester Rochester New York 14642
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Greenville Health System - Patewood Greenville South Carolina 29615
Monument Health Clinical Research Rapid City South Dakota 57701
UT Le Bonheur Pediatric Specialists Memphis Tennessee 38105
University of Texas Southwestern Medical Center Dallas Texas 75235
Baylor College of Medicine Advanced Liver Therapies Houston Texas 77030
University of Virginia Charlottesville Virginia 22908
Seattle Children's Hospital Seattle Washington 98003
Multicare Health System Institute for Research and Innovation Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.

Recently updated Diabetes Mellitus, Type 2 trials

Other public records listing Diabetes Mellitus, Type 2. Sorted by last update posted; newest first. Not a recommendation.

All Diabetes Mellitus, Type 2 trials →

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02856113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 18, 2022 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02856113 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →