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Diabetes Mellitus, Type 2Phase 3NCT02856113

Phase 3 Alogliptin Pediatric Study

A Phase 3 study testing Alogliptin Benzoate in people with Diabetes Mellitus, Type 2, run by Takeda at 67 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Alogliptin Benzoate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
67 sitesin 7 countries
Study dates
14 Oct 2016to 14 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.
  • Must not have received an antidiabetic agent other than metformin or insulin within the 12 weeks prior to randomization.
  • 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.
  • 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).
  • 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.

Trial locations and contacts

67 sites in 7 countries.

67 sites in 7 countries

United States34 sites

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • University of Virginia

    Charlottesville, Virginia, 22908

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

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Endocrine Consultants Research

    Columbus, Georgia, 31904

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235

  • University of Florida

    Gainesville, Florida, 32610

  • Greenville Health System - Patewood

    Greenville, South Carolina, 29615

  • Gulfside Clinical Research

    Gulfport, Mississippi, 39501

  • Baylor College of Medicine Advanced Liver Therapies

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • Nemours Childrens Specialty Care - Jacksonville

    Jacksonville, Florida, 32207

  • Horizon View Medical Center

    Las Vegas, Nevada, 89149

  • University of Kentucky Health Care

    Lexington, Kentucky, 40504

  • Arkansas Children's Hospital Research Institute

    Little Rock, Arkansas, 72202

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • UT Le Bonheur Pediatric Specialists

    Memphis, Tennessee, 38105

  • Baptist Diabetes Associates Research

    Miami, Florida, 33156

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

    Minneapolis, Minnesota, 55454

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

  • Endocrine Consultants Research - Oak Hill Court

    Newnan, Georgia, 30265

  • Sherif Khamis

    Palmdale, California, 93550

  • Lucile Packard Children's Hospital at Stanford University

    Palo Alto, California, 94304

  • Saint Joseph's Regional Medical Center - Paterson

    Paterson, New Jersey, 07503

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • University of Rochester

    Rochester, New York, 14642

  • Seattle Children's Hospital

    Seattle, Washington, 98003

  • Saint Louis University

    St Louis, Missouri, 63104

  • Multicare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405

  • University of South Florida/USF Health

    Tampa, Florida, 33612

  • Touro University California

    Vallejo, California, 94592

  • Children's National Health System

    Washington D.C., District of Columbia, 20010

Other trials in United States

Mexico11 sites

  • Ono Consultoria Medica Integral

    Aguascalientes, 20129

  • Centro de Investigacion Cardiometabolica de Aguascalientes

    Aguascalientes

  • Endo Clinic

    Guadalajara, Jalisco, 44130

  • Desarrollo Etico en Investigacion Clinica

    Guadalajara, Jalisco, 44500

  • Instituto Nacional de Pediatria

    Mexico City, Mexico City, 14530

  • Mentrials, SA de CV

    Mexico City, Mexico City, 6400

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

    Mexico City, Mexico City, 6700

  • IECSI-Centro Medico y de Investigacion Clinica

    Monterrey, Nuevo León, 64310

  • EL CIELO Medical Center

    Puebla City, 72160

  • Centro Integral Medico Sjr

    San Juan del Río, Querétaro, 76800

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

    Zapopan, Jalisco, 45030

Other trials in Mexico

Russia6 sites

  • Republican Children's Clinical Hospital-Izhevsk

    Izhevsk, Udmurtiya Republic, 426009

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

    Kemerovo, 650066

  • Novosibirsk State Medical University

    Novosibirsk, 630087

  • Omsk Regional Children's Hospital

    Omsk, 644001

  • Saint Petersburg State Pediatric Medical Academy

    Saint Petersburg, Sankt-Peterburg, 194100

  • Siberian State Medical University

    Tomsk, 634050

Other trials in Russia

Poland5 sites

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, Lubusz Voivodeship, 67-100

  • MedPolonia

    Poznan, Greater Poland Voivodeship, 60-693

  • Sonomed

    Szczecin, West Pomeranian Voivodeship, 71-685

  • Holmed

    Warsaw, Masovian Voivodeship, 01-494

  • Specjalistyczna Praktyka Lekarska ASPIRO

    Wroclaw, Lower Silesian Voivodeship, 50-341

Other trials in Poland

Brazil4 sites

  • Hospital Universitario Joao de Barros Barreto

    Belém, Pará, 66073-005

  • Instituto de Estudos e Pesquisas Clinicas do Ceara

    Fortaleza, Ceará, 60160-230

  • Instituto da Crianca com Diabetes

    Porto Alegre, Rio Grande do Sul, 91350-250

  • Hospital Sirio Libanes

    São Paulo, 01308-050

Other trials in Brazil

Italy4 sites

  • Ospedale Policlinico SS Annunziata

    Chieti, 66100

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo

  • Ospedale Pediatrico Bambino Gesu

    Roma, 146

Other trials in Italy

Israel3 sites

  • Hadassah University Hospital Mount Scopus

    Jerusalem, 9765422

  • The Chaim Sheba Medical Center

    Ramat Gan, Tel Aviv, 52621

  • Clalit Medical Center

    Tel Aviv, 6203854

Other trials in Israel

About this study

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

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).

Read the 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.

Being tested
Alogliptin Benzoate, Placebo
Keywords
Drug Therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alogliptin BenzoateDrug

    Also called SYR-322, Nesina, Vipidia

    Alogliptin benzoate tablets.

  • PlaceboDrug

    Alogliptin placebo-matching tablets.

Study groups in NCT02856113
Study groupRoleWhat they receive
PlaceboPlacebo comparatorAlogliptin 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.
Receives: Drug: Placebo
Alogliptin 25 mgExperimentalAlogliptin 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.
Receives: Drug: Alogliptin Benzoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 26

Secondary outcomes (11)

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

    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 Weeks 12, 18, 39 and 52 relative to Baseline. MMRM was used for the analysis.

    Measured: Baseline and Weeks 12, 18, 39 and 52

  2. Percentage of Participants With Clinically Significant Physical Examination Findings

    Physical examination included examination of the following body systems: (1) respiratory system; (2) cardiovascular system; (3) nervous system (4) dermatologic system; and (5) gastrointestinal system. A summarized data for the above body systems was reported for participants with clinically significant findings.

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

  3. Percentage of Participants With Abnormal Vital Signs Values

    Vital signs included body temperature (oral or tympanic measurement), respiratory rate, blood pressure [systolic blood pressure (SBP) and diastolic blood pressure (DBP)] resting more than 5 minutes, and pulse (beats per minute). Data for participants with abnormal vital signs was reported. The percentage of participants are calculated based on the participants with non-missing data at that time-point.

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

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

    Measured: Week 26 and 52

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

    An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

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

  6. Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions

    The percentage of participants are calculated based on the participants with non-missing data at that time-point.

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

  7. Percentage of Participants With Hypoglycemia

    Mild to moderate hypoglycemia (abnormal low blood sugar) was defined as blood glucose less than (<) 60 milligram per deciliter (mg/dL) (3.33 millimole per liter [mmol/L]) in the presence of symptoms, or blood glucose <50 mg/dL (2.78 mmol/L) with or without symptoms. Severe hypoglycemia was defined as any episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, associated with a documented blood glucose <60 mg/dL (3.33 mmol/L) (unless the clinical situation makes obtaining a blood glucose difficult [example, it involves coma or seizure]).

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

  8. Percentage of Participants With Abnormal Safety Laboratory Findings

    The percentage of participants with any abnormal standard safety laboratory values (hematology, serum chemistry, and urinalysis) were collected throughout study. Abnormal values for hematology included hematocrit (percentage of hematocrit [%]), hemoglobin (grams per liter [g/L]), erythrocyte mean corpuscular volume (MCV)(femtoliter [fL]), erythrocytes (10^12/L), and leukocytes (10^9/L). Abnormal values for serum chemistry included for alanine aminotransferase (units per liter [U/L]), aspartate aminotransferase (U/L), cholesterol (millimoles per liter [mmol/L]), gamma glutamyl transferase (U/L), glucose (mmol/L): < 2.8 mmol/L, potassium (mmol/L), sodium (mmol/L), and triglycerides (mmol/L). ULN is upper limit of normal and LLN is lower limit of normal.

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

  9. Change From Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52

    Biomarkers of bone turnover are bone-specific alkaline phosphatase to assess changes in bone formation and C-terminal telopeptide (CTX) to assess changes in bone resorption.

    Measured: Baseline, Weeks 26 and 52

  10. Change From Baseline in CD26 (CD4+T Cells) Surface Antigen Levels at Weeks 26 and 52

    Measured: Baseline, Weeks 26 and 52

  11. Change From Baseline in CD26 (CD8+T Cells) Surface Antigen Levels at Weeks 26 and 52

    Measured: Baseline, Weeks 26 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2016 (estimated)
  2. Study start14 Oct 2016
  3. Primary completion6 Aug 2021
  4. Study completion14 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856113
Sponsor's protocol ID
SYR-322_309
Other IDs
U1111-1174-1923, 2015-000208-25, 173300410A0019, MOH_2017-12-26_000698, 2015
Status last verified
Oct 2022
First submitted
2 Aug 2016
Last updated
19 Oct 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • 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.

    PubMed 40032809

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alogliptin Benzoate in people with Diabetes Mellitus, Type 2, run by Takeda at 67 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Mexico, Russia, Poland, Brazil and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline and Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02856113, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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