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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-000208-25
    Sponsor's Protocol Code Number:SYR-322_309
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-000208-25
    A.3Full title of the trial
    A Multicenter, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to be conducted in many hospitals and in different countries with the medicinal substance alogliptin as treatment in patients with Diabetes Type 2 aged between 10-17 years.
    A.4.1Sponsor's protocol code numberSYR-322_309
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/255/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Centre Europe Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Development Centre Europe Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Centre Europe, Ltd.
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44020 3116 8000
    B.5.5Fax number+440203116 8199
    B.5.6E-mailclinicaloperations@tgrd.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vipidia 
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlogliptin benzoate
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlogliptin
    D.3.9.1CAS number 850649-61-5
    D.3.9.2Current sponsor codeSYR-322
    D.3.9.3Other descriptive nameALOGLIPTIN BENZOATE
    D.3.9.4EV Substance CodeSUB32165
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 Diabetes Mellitus
    E.1.1.1Medical condition in easily understood language
    Diabetes Type 2
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study will be to evaluate the efficacy 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, as measured by the glycosylated hemoglobin (HbA1c) change from Baseline at Week 26 in pediatric subjects with T2DM.
    E.2.2Secondary objectives of the trial
    To evaluate the HbA1c change from Baseline after treatment with alogliptin as compared with placebo at Weeks 12, 18, 39, and 52.
    To evaluate the safety of alogliptin compared to placebo by assessing:
    - The incidence of hypoglycemic events, treatment emergent adverse events (TEAEs), clinical laboratory parameters, electrocardiogram (ECG) readings, physical examinations, and vital signs for Weeks 26 and 52.
    - The effects on biomarkers of bone turnover (bone-specific alkaline phosphatase and C-terminal telopeptide [CTX]) markers at Weeks 26 and 52.
    - The effects on CD26 surface antigen levels at Weeks 26 and 52.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subjects will have the option to provide a separate consent for pharmacogenomic sample collection to be used in a pharmacogenomic sub-study, which details are included in the main study protocol. Specific purposes include:
    - Identifying genetic reasons why certain people respond differently to alogliptin.
    - Finding out more information about how alogliptin works.
    - Generating information needed for research, development, and regulatory approval of tests to predict response to alogliptin.
    - Identifying variations in genes related to the biological target of alogliptin
    This information may be used, for example, to develop a better understanding of the safety and efficacy of alogliptin and other study medications, and for improving the efficiency, design and study methods of future research studies.
    E.3Principal inclusion criteria
    Subject eligibility is determined according to the following criteria prior to entry into the study:

    1. A confirmed diagnosis of T2DM using American Diabetes Association (ADA) and World Health Organization (WHO) criteria (laboratory determinations of FPG >126 mg/dL, random glucose >200 mg/dL [≥11.10 mmol/L], HbA1c ≥6.5%, or 2-hour oral glucose tolerance test [OGTT] glucose ≥200 mg/dL), documented in the subjects’ medical record.
    2. Male or female subjects, 10 to 17 years of age, inclusive, at the time of randomization.
    For subjects 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:
    3. The subject must have a fasting C-peptide concentration ≥0.6 ng/mL (≥0.20 nmol/L) (drawn at least 1 week after treatment for ketosis or acidosis, if applicable).
    4. 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.
    5. The subject must have a BMI >85th percentile, documented at randomization.
    6. The subject is thought to be able to swallow the tablet containing the study medication.
    7. A male subject who is sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing of informed consent throughout the duration of the study.
    8. A female subject of childbearing potential* who is sexually active with a male partner agrees to use routinely adequate contraception* from signing of informed consent throughout the duration of the study.
    *Female subjects of childbearing potential are defined as reaching Tanner Stage 3. Definitions and acceptable methods of contraception are defined in Protocol Section 9.1.9 Contraception and Pregnancy Avoidance Procedure and reporting responsibilities are defined in Section 9.1.10 Pregnancy.
    9. The subject and his/her legal representative (ie, parents or legal guardians) are able and willing to provide written informed consent/assent.
    10. The subject and his/her legal representative (ie, parents or legal guardians) are capable of understanding and complying with the protocol requirements, including scheduled clinic appointments.
    11. The subject and his/her legal representative (ie, parents or legal guardians) are able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete subject diaries.
    For subjects 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 (refer to Section 7.3 of the Study Protocol).
    E.4Principal exclusion criteria
    Any subject who meets any of the following criteria will not qualify for entry into the study:

    1. The subject is treatment naive
    2. The subject has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors, metformin, insulin or related compounds.
    3. The subject has a confirmed diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young (MODY).
    4. The subject has a hemoglobin level <11.0 g/dL (<110 g/L) for males and <10.0 g/dL (<100 g/L) for females.
    5. The subject has a history of any hemoglobinopathy that may affect determination of HbA1c levels.
    6. The subject has a history of bariatric surgery.
    7. The subject has a history of proliferative diabetic retinopathy within the 6 months prior to Screening.
    8. The subject has had an episode of diabetic ketoacidosis (DKA) at any time after diagnosis of T2DM.
    9. The subject has a history of pancreatitis.
    10. Serum creatinine ≥1.5 mg/dL for male subjects or ≥1.4 mg/dL for female subjects, or creatinine clearance <60 mL/min based on calculation by central lab using the Schwartz formula for estimated glomerular filtration rate (eGFR) at the Screening Visit.
    11. The subject has a documented history of infection with human immunodeficiency virus or chronic active viral hepatitis.
    12. The subject has any unstable endocrine, psychiatric or severe rheumatic disorder, or major illness or debility that, in the Investigator’s opinion, prohibits the subject from being a suitable candidate for and/or completing the study, or may affect the interpretability of his/her efficacy or safety data.
    13. Female subjects who are pregnant, planning to become pregnant, or who admit to sexual activity without appropriate contraception.
    14. The subject and/or his/her legal representative (ie, 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.
    15. The subject and/or his/her legal representative (ie, parents or legal guardians) is an immediate family member (ie, child or sibling) of a study site employee who is involved in the conduct of this study.
    E.5 End points
    E.5.1Primary end point(s)
    HbA1c change from Baseline to Week 26
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 26
    E.5.2Secondary end point(s)
    Efficacy:
    - HbA1c change from Baseline at Weeks 12, 18, 39, and 52.

    Safety:
    - Physical examination findings.
    - Vital sign measurements.
    - 12-lead ECG abnormalities.
    - Adverse events (AEs).
    - Incidence of infections (Total and urinary and respiratory tract infections) and hypersensitivity reactions.
    - Incidence of hypoglycemia.
    - Clinical laboratory evaluations (hematology, serum chemistry, and urinalysis).
    - Change from Baseline in biomarkers of bone turnover (bone-specific alkaline phosphatase and CTX) at Weeks 26 and 52.
    - Change from Baseline in CD26 surface antigen levels at Weeks 26 and 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points including Weeks 26 and 52 – given that other are checked more often and some such as AEs have no specific timepoint (ongoing for IDMC and total for CSR)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Germany
    Israel
    Italy
    Mexico
    Poland
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Definition of the end of the trial is the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 200
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 180
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The study medication will not be provided by the sponsor upon completion of the subject’s
    participation in the study. The subject should be returned to the care of a physician and standard therapies should be initiated, as required. Subjects will be offered clinical follow-up examinations as considered appropriate per the treating physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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