Phase 3 Alogliptin Pediatric Study

NCT02856113 | Completed Phase 3 Results DMC FDA Drug

• 5 other identifiers: SYR-322_309U1111-1174-19232015-000208-25173300410A0019MOH_2017-12-26_000698
• Study Type: interventional
• Target: 152
• Locations: 7 countries
• Sites: 67

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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

  Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Week 26 relative to Baseline. Mixed model for repeated measures (MMRM) was used for the analysis.

  Baseline and Week 26

Secondary Outcomes (11)

• Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52

  Baseline and Weeks 12, 18, 39 and 52

• Percentage of Participants With Clinically Significant Physical Examination Findings

  From Day 1 to end of treatment period (up to 52 weeks)

• Percentage of Participants With Abnormal Vital Signs Values

  From Day 1 to end of treatment period (up to 52 weeks)

• Percentage of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings

  Week 26 and 52

• Percentage of Participants With Treatment-emergent Adverse Events (TEAE)

  From the study start up to end of the study (up to 54 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Alogliptin 25 mg

EXPERIMENTAL

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.

Drug: Alogliptin Benzoate

Interventions

Alogliptin Benzoate DRUG

Alogliptin benzoate tablets.

Also known as: SYR-322, Nesina, Vipidia

Alogliptin 25 mg

Placebo DRUG

Alogliptin placebo-matching tablets.

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Has a history of hypersensitivity or allergy to alogliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, metformin, insulin or related compounds.
• Has a confirmed diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young (MODY).
• 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.
• Has a history of any hemoglobinopathy that may affect determination of HbA1c levels.
• Has a history of bariatric surgery.
• Has a history of proliferative diabetic retinopathy within the 6 months prior to Screening.
• Has had more than 1 episode of diabetic ketoacidosis (DKA) at any time after diagnosis of T2DM.
• Has a history of more than 1 episode of pancreatitis.
• 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.
• Has a documented history of infection with human immunodeficiency virus or chronic active viral hepatitis.
• 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:
• 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.
• The participant must not have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to randomization.

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (67)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Sherif Khamis

Palmdale, California, 93550, United States

Location

Lucile Packard Children's Hospital at Stanford University

Palo Alto, California, 94304, United States

Location

Touro University California

Vallejo, California, 94592, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Nemours Childrens Specialty Care - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Baptist Diabetes Associates Research

Miami, Florida, 33156, United States

Location

University of South Florida/USF Health

Tampa, Florida, 33612, United States

Location

Endocrine Consultants Research

Columbus, Georgia, 31904, United States

Location

Endocrine Consultants Research - Oak Hill Court

Newnan, Georgia, 30265, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kentucky Health Care

Lexington, Kentucky, 40504, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

Location

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

Minneapolis, Minnesota, 55454, United States

Location

Gulfside Clinical Research

Gulfport, Mississippi, 39501, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Horizon View Medical Center

Las Vegas, Nevada, 89149, United States

Location

Saint Joseph's Regional Medical Center - Paterson

Paterson, New Jersey, 07503, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Greenville Health System - Patewood

Greenville, South Carolina, 29615, United States

Location

Monument Health Clinical Research

Rapid City, South Dakota, 57701, United States

Location

UT Le Bonheur Pediatric Specialists

Memphis, Tennessee, 38105, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine Advanced Liver Therapies

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98003, United States

Location

Multicare Health System Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Instituto de Estudos e Pesquisas Clinicas do Ceara

Fortaleza, Ceará, 60160-230, Brazil

Location

Hospital Universitario Joao de Barros Barreto

Belém, Pará, 66073-005, Brazil

Location

Instituto da Crianca com Diabetes

Porto Alegre, Rio Grande do Sul, 91350-250, Brazil

Location

Hospital Sirio Libanes

São Paulo, 01308-050, Brazil

Location

The Chaim Sheba Medical Center

Ramat Gan, Tel Aviv, 52621, Israel

Location

Hadassah University Hospital Mount Scopus

Jerusalem, 9765422, Israel

Location

Clalit Medical Center

Tel Aviv, 6203854, Israel

Location

Ospedale Policlinico SS Annunziata

Chieti, 66100, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Location

Ospedale Pediatrico Bambino Gesu

Roma, 146, Italy

Location

Endo Clinic

Guadalajara, Jalisco, 44130, Mexico

Location

Desarrollo Etico en Investigacion Clinica

Guadalajara, Jalisco, 44500, Mexico

Location

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

Zapopan, Jalisco, 45030, Mexico

Location

Instituto Nacional de Pediatria

Mexico City, Mexico City, 14530, Mexico

Location

Mentrials, SA de CV

Mexico City, Mexico City, 6400, Mexico

Location

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

Mexico City, Mexico City, 6700, Mexico

Location

IECSI-Centro Medico y de Investigacion Clinica

Monterrey, Nuevo León, 64310, Mexico

Location

Centro Integral Medico Sjr

San Juan del Río, Querétaro, 76800, Mexico

Location

Ono Consultoria Medica Integral

Aguascalientes, 20129, Mexico

Location

Centro de Investigacion Cardiometabolica de Aguascalientes

Aguascalientes, Mexico

Location

EL CIELO Medical Center

Puebla City, 72160, Mexico

Location

MedPolonia

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Specjalistyczna Praktyka Lekarska ASPIRO

Wroclaw, Lower Silesian Voivodeship, 50-341, Poland

Location

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

Holmed

Warsaw, Masovian Voivodeship, 01-494, Poland

Location

Sonomed

Szczecin, West Pomeranian Voivodeship, 71-685, Poland

Location

Saint Petersburg State Pediatric Medical Academy

Saint Petersburg, Sankt-Peterburg, 194100, Russia

Location

Republican Children's Clinical Hospital-Izhevsk

Izhevsk, Udmurtiya Republic, 426009, Russia

Location

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

Kemerovo, 650066, Russia

Location

Novosibirsk State Medical University

Novosibirsk, 630087, Russia

Location

Omsk Regional Children's Hospital

Omsk, 644001, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

Related Publications (1)

• 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.

  PMID: 40032809 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: October 14, 2016
• Primary Completion: August 6, 2021
• Study Completion: February 14, 2022
• Last Updated: October 19, 2022
• Results First Posted: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect Participant privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

IL (3); IT (4); PL (5); RU (6); ME (11); US (34); BR (4)