Phase 3 Alogliptin Pediatric Study

NCT ID: NCT02856113

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-14
• Study Completion Date: 2022-02-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Alogliptin matching-placebo tablets, orally, once daily (QD) for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Alogliptin placebo-matching tablets.

Alogliptin 25 mg

Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.

Group Type: EXPERIMENTAL

Alogliptin Benzoate

Intervention Type: DRUG

Alogliptin benzoate tablets.

Interventions

Alogliptin Benzoate

Alogliptin benzoate tablets.

Intervention Type: DRUG

Placebo

Alogliptin placebo-matching tablets.

Intervention Type: DRUG

Other Intervention Names

SYR-322; Nesina; Vipidia

Eligibility Criteria

Inclusion Criteria

1. Has a confirmed diagnosis of T2DM using American Diabetes Association (ADA) and World Health Organization (WHO) criteria (laboratory determinations of fasting plasma glucose [FPG] greater than or equal to [>=] 126 mg/dL, random glucose >=200 mg/dL [>=11.10 mmol/L], HbA1c >=6.5 percent (%), or 2-hour oral glucose tolerance test [OGTT] glucose >=200 mg/dL), documented in the participants' medical record.

2. The participant and/or his/her legal representative (that is, parents or legal guardians) are able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete participant diaries.

Exclusion Criteria

1. Has a history of hypersensitivity or allergy to alogliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, metformin, insulin or related compounds.

2. Has a confirmed diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young (MODY).

3. Has a hemoglobin level <11.0 gram per deciliter (g/dL) (<110 gram per liter [g/L]) for males and <10.0 g/dL (<100 g/L) for females.

4. Has a history of any hemoglobinopathy that may affect determination of HbA1c levels.

5. Has a history of bariatric surgery.

6. Has a history of proliferative diabetic retinopathy within the 6 months prior to Screening.

7. Has had more than 1 episode of diabetic ketoacidosis (DKA) at any time after diagnosis of T2DM.

8. Has a history of more than 1 episode of pancreatitis.

9. Has serum creatinine >=1.5 mg/dL for male participants or >=1.4 mg/dL for female participants, or creatinine clearance <60 milliliter per minute (mL/min) based on calculation by central lab using the Schwartz formula for estimated glomerular filtration rate (eGFR) at screening Visit.

10. Has a documented history of infection with human immunodeficiency virus or chronic active viral hepatitis.

11. The participant and/or his/her legal representative (that is, parents or legal guardians) is unable to understand verbal or written English, or any other language for which a certified translation of the approved informed consent/assent is available.

Additional Criteria That Must be Met Prior to Randomization:

For participants who have had the diagnosis of T2DM for less than 1 year and/or who are taking insulin at Screening, additional criteria will need to be met prior to randomization:

1. Must have an HbA1c level of >=6.5% to <11.0% if the participant is treatment naïve or on metformin alone or >=7.0% to <11.0% if the participant is on insulin alone or in combination with metformin.

2. The participant must not have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to randomization.

3. Must not have received an antidiabetic agent other than metformin or insulin within the 12 weeks prior to randomization.

4. Must not have received oral or parenteral steroids for more than 3 weeks (cumulatively) within the 6 months prior to randomization or have received a course of oral or parenteral steroids within the 2 months prior to randomization.

5. Has a systolic blood pressure <160 millimeter of mercury (mmHg) and a diastolic pressure <100 mm Hg. (Antihypertensive medications will be allowed during the study).

6. Has an alanine aminotransferase (ALT) level <3*upper limit of normal (ULN) or an ALT level <5 *ULN with a confirmed diagnosis of nonalcoholic fatty liver disease (NAFLD).7. Does not plan to leave the geographic area within 1 calendar year following randomization.

For participants who have had the diagnosis of T2DM for less than 1 year and/or who are taking insulin prior to randomization, the following criteria must also be met:

8. Must have a fasting C-peptide concentration>=0.6 nanogram per milliliter (ng/mL) (>=0.20 nanomole per liter [nmol/L]) (drawn at least 1 week after treatment for ketosis or acidosis, if applicable).

9. No presence of autoantibodies as documented by glutamic acid decarboxylase [GAD] 65 and islet antigen [IA]-2 antibodies below the upper limit of the normal reference ranges at randomization.

10. Have a body mass index (BMI) greater than (>) 85th percentile, documented at randomization.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Sherif Khamis

Palmdale, California, United States

Lucile Packard Children's Hospital at Stanford University

Palo Alto, California, United States

Touro University California

Vallejo, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Children's National Health System

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Nemours Childrens Specialty Care - Jacksonville

Jacksonville, Florida, United States

Baptist Diabetes Associates Research

Miami, Florida, United States

University of South Florida/USF Health

Tampa, Florida, United States

Endocrine Consultants Research

Columbus, Georgia, United States

Endocrine Consultants Research - Oak Hill Court

Newnan, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Kentucky Health Care

Lexington, Kentucky, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Ochsner Baptist Medical Center

New Orleans, Louisiana, United States

University of Minnesota Masonic Children's Hospital - Pediatric Specialty Care Discovery Clinic

Minneapolis, Minnesota, United States

Gulfside Clinical Research

Gulfport, Mississippi, United States

Saint Louis University

St Louis, Missouri, United States

Horizon View Medical Center

Las Vegas, Nevada, United States

Saint Joseph's Regional Medical Center - Paterson

Paterson, New Jersey, United States

University of Rochester

Rochester, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Greenville Health System - Patewood

Greenville, South Carolina, United States

Monument Health Clinical Research

Rapid City, South Dakota, United States

UT Le Bonheur Pediatric Specialists

Memphis, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine Advanced Liver Therapies

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Multicare Health System Institute for Research and Innovation

Tacoma, Washington, United States

Instituto de Estudos e Pesquisas Clinicas do Ceara

Fortaleza, Ceará, Brazil

Hospital Universitario Joao de Barros Barreto

Belém, Pará, Brazil

Instituto da Crianca com Diabetes

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sirio Libanes

São Paulo, , Brazil

The Chaim Sheba Medical Center

Ramat Gan, Tel Aviv, Israel

Hadassah University Hospital Mount Scopus

Jerusalem, , Israel

Clalit Medical Center

Tel Aviv, , Israel

Ospedale Policlinico SS Annunziata

Chieti, , Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Ospedale Pediatrico Bambino Gesu

Roma, , Italy

Endo Clinic

Guadalajara, Jalisco, Mexico

Desarrollo Etico en Investigacion Clinica

Guadalajara, Jalisco, Mexico

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Zapopan, Jalisco, Mexico

Instituto Nacional de Pediatria

Mexico City, Mexico City, Mexico

Mentrials, SA de CV

Mexico City, Mexico City, Mexico

Centro de Atencion e Investigacion en Factores de Riesgo Cardiovascular Omega (Clinica Omega)

Mexico City, Mexico City, Mexico

IECSI-Centro Medico y de Investigacion Clinica

Monterrey, Nuevo León, Mexico

Centro Integral Medico Sjr

San Juan del Río, Querétaro, Mexico

Ono Consultoria Medica Integral

Aguascalientes, , Mexico

Centro de Investigacion Cardiometabolica de Aguascalientes

Aguascalientes, , Mexico

EL CIELO Medical Center

Puebla City, , Mexico

MedPolonia

Poznan, Greater Poland Voivodeship, Poland

Specjalistyczna Praktyka Lekarska ASPIRO

Wroclaw, Lower Silesian Voivodeship, Poland

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, Poland

Holmed

Warsaw, Masovian Voivodeship, Poland

Sonomed

Szczecin, West Pomeranian Voivodeship, Poland

Saint Petersburg State Pediatric Medical Academy

Saint Petersburg, Sankt-Peterburg, Russia

Republican Children's Clinical Hospital-Izhevsk

Izhevsk, Udmurtiya Republic, Russia

Kuzbass Regional Clinical Hospital n.a. S.V. Belyaev

Kemerovo, , Russia

Novosibirsk State Medical University

Novosibirsk, , Russia

Omsk Regional Children's Hospital

Omsk, , Russia

Siberian State Medical University

Tomsk, , Russia

Countries

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

References

Peng XV, Klingensmith G, Hsia DS, Xie Y, Czerniak R, Tamborlane WV, Shah AS. A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus. Diabetes Ther. 2025 May;16(5):865-883. doi: 10.1007/s13300-025-01700-3. Epub 2025 Mar 4.

Reference Type: DERIVED

PMID: 40032809 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1174-1923

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-000208-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

173300410A0019

Identifier Type: REGISTRY

Identifier Source: secondary_id

MOH_2017-12-26_000698

Identifier Type: OTHER

Identifier Source: secondary_id

SYR-322_309

Identifier Type: -

Identifier Source: org_study_id