Last updated on June 2018

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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Touro University California
Vallejo, CA United States
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Endocrine Consultants Research
Columbus, GA United States
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Ochsner Baptist Medical Center
New Orleans, LA United States
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Multicare Health System Institute for Research and Innovation
Tacoma, WA United States
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Hospital Universitario Joao de Barros Barreto
Belem, Brazil
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Hospital Nossa Senhora da Conceicao - Instituto da Crianca com Diabetes
Porto Alegre, Brazil
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Instituto de Estudos e Pesquisas Clinicas IEP-CE
Fortaleza, Brazil
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Pfutzner Science & Health Institute GmbH
Mainz, Germany
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Hadassah Medical Center
Jerusalem, Israel
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Chaim Sheba Medical Center
Ramat Gan, Israel
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Istituto G Gaslini Ospedale Pediatrico IRCCS
Genova, Italy
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Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, Italy
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Arcispedale Santa Maria Nuova
Parma, Italy
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Ospedale Pediatrico Bambino Gesu
Roma, Italy
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Centro de Investigacion Cardiometabolica de Aguascalientes
Aguascalientes, Mexico
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Medical University of Silesia
Katowice, Poland
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Med-Polonia Sp. z o.o.
Poznan, Poland
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Arkansas Children's Hospital Research Institute
Little Rock, AR United States
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Sherif Khamis
Palmdale, CA United States
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Lucile Packard Children's Hospital at Stanford University
Palo Alto, CA United States
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Yale New Haven Hospital
New Haven, CT United States
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University of Florida
Gainesville, FL United States
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Nemours Childrens Specialty Care - Jacksonville
Jacksonville, FL United States
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Baptist Diabetes Associates Research
Miami, FL United States
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University of South Florida
Tampa, FL United States
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Indiana University
Indianapolis, IN United States
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University of Iowa
Iowa City, IA United States
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University of Kentucky
Lexington, KY United States
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Pennington Biomedical Research Center
Baton Rouge, LA United States
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University of Minnesota Masonic Children's Hospital - Pediatric Specialty Care Discovery Clinic
Minneapolis, MN United States
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SSM Cardinal Glennon Children's Medical Center
Saint Louis, MO United States
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Horizon View Medical Center
Las Vegas, NV United States
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Saint Joseph's Regional Medical Center - Paterson
Paterson, NJ United States
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University of Rochester
Rochester, NY United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Greenville Health System - Patewood
Greenville, SC United States
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Regional Medical Clinic
Rapid City, SD United States
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UT Le Bonheur Pediatric Specialists
Memphis, TN United States
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University of Texas Southwestern Medical Center
Dallas, TX United States
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Baylor College of Medicine
Houston, TX United States
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University of Virginia
Charlottesville, VA United States
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Seattle Children's Hospital
Seattle, WA United States
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Centro de Pesquisas em Diabetes - CPD
Porto Alegre, Brazil
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Hospital Sirio Libanes
Sao Paulo, Brazil
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Clalit Medical Center
Tel Aviv, Israel
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Mentrials, SA de CV
Ciudad De Mexico, Mexico
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Centro de Atencion e Investigacion en Factores de Riesgo Cardiovascular Omega (Clinica Omega)
Ciudad De Mexico, Mexico
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Desarrollo Etico en Investigacion Clinica
Guadalajara, Mexico
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iBiomed Investigacion Biomedica Guadalajara
Zapopan, Mexico
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Centro Integral Medico Sjr
San Juan del Rio, Mexico
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Ono Consultoria Medica Integral
Aguascalientes, Mexico
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Samodzielny Publiczny Szpital Kliniczny nr 1 Pomorskiego UM im. prof. Tadeusza Sokolowskiego
Szczecin, Poland
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Twoja Przychodnia - Centrum Medyczne Nowa Sol
Szczecin, Poland
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