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    The EU Clinical Trials Register currently displays   39816   clinical trials with a EudraCT protocol, of which   6534   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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    EudraCT Number:2015-000408-24
    Sponsor's Protocol Code Number:D5551C00002
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-02-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-000408-24
    A.3Full title of the trial
    A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents with Type 2 Diabetes
    III. fázisú, kettős vak, placebo kontrollált, randomizált, multicentrikus vizsgálat a hetente egyszer alkalmazott exenatid biztonságosságának és hatásosságának értékelésére 2-es típusú diabéteszben szenvedő serdülők esetében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study of Exenatide Once Weekly in Adolescents with Type 2 Diabetes
    A.4.1Sponsor's protocol code numberD5551C00002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01554618
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/197/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    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 supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointAstraZeneca Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    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. name BYDUREON (2 mg powder and solvent for prolonged-release suspension for injection)
    D. of the Marketing Authorisation holderAstraZeneca AB
    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 nameExenatide
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEXENATIDE
    D.3.9.1CAS number 141758-74-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboPowder and solvent for suspension for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous 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
    E.1.1.1Medical condition in easily understood language
    High Blood Sugar
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10012602
    E.1.2Term Diabetes mellitus (incl subtypes)
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect on glycemic control, as measured by glycosylated hemoglobin (HbA1c), of exenatide once weekly (EQW) following 24 weeks of treatment compared to placebo in children and adolescents with type 2 diabetes mellitus

    To evaluate the safety and tolerability of EQW compared to placebo following 24 weeks of treatment in children and adolescents with type 2 diabetes mellitus
    E.2.2Secondary objectives of the trial
    To compare the effects of EQW following 24 weeks of treatment to those achieved by placebo in children and adolescents with T2D on the following: Fasting plasma glucose concentration, Proportion of patients achieving HbA1c goals, Body weight and Tanner pubertal stage, Blood pressure and lipids

    To assess the effects of long-term EQW therapy (~1 year) in children and adolescents with T2D on the following: Long-term safety and tolerability, Parameters related to glycemic control, including HbA1c, fasting plasma glucose concentration, and proportion of patients achieving HbA1c goals, Body weight and Tanner pubertal stage, Blood pressure and lipids

    To examine the effect of exenatide once weekly on beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) as measured by the homeostatic model assessment (HOMA) in children and adolescents with T2D who are not taking insulin

    Assess pk of exenatide once weekly in children and adolescents with T2D

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Mixed Meal Substudy, Amendment 3.0, 09 April 15 (Appendix F of protocol)

    The primary objective of this exploratory substudy is: To evaluate the effect of exenatide once weekly on postprandial beta-cell function as assessed by C peptide secretion during a mixed meal test, following approximately 28 weeks of exenatide once weekly treatment and at approximately 10 to 12 weeks following cessation of drug therapy.

    The secondary objective of this exploratory substudy is: To assess postprandial glucose and glucagon responses during a mixed meal test following approximately 28 weeks of exenatide once weekly treatment and at approximately 10 to 12 weeks following cessation of drug therapy.

    Blood samples for pharmacokinetic measurements of plasma exenatide concentrations for potential future analysis will be collected within the 30 min prior to the start of the standardized meal
    E.3Principal inclusion criteria
    Each patient must meet the following criteria to be enrolled in this study.
    1. Is a child or an adolescent of 10 to <18 years old, at Visit 1 (Screening)
    2. Has been diagnosed with type 2 diabetes mellitus per American Diabetes Association diagnostic criteria
    3. HbA1c of 6.5% to 11.0%, inclusive, in patients not taking insulin/SU, and of 6.5% to 12.0%, inclusive, in patients taking insulin/SU, at Visit 1 (Screening)
    4. Has a C-peptide of >0.6 ng/L at Visit 1 (Screening)
    5. Has been treated with diet and exercise alone or in combination with a stable dose of an oral antidiabetic agent (e.g., metformin and/or SU) and/or insulin for their type 2 diabetes for at least 2 months prior to Visit 1 (Screening)
    6. Has a fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at Visit 1(Screening)
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from the study.
    1. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator, including but not limited to the following conditions: a. Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal (ULN), b. Renal disease or serum creatinine >1.5 mg/dL (132.6 μmol/L) (males) or 1.4 mg/dL (123.8 μmol/L) (females), c. Gastrointestinal disease deemed significant by the Investigator, d. Organ transplantation, e. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus), f. Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening)
    2. Has positive antibody titers to glutamic acid decarboxylase (GAD65) or islet cell antigen (ICA512) at Visit 1 (Screening)
    3. Has a personal or family history of elevated calcitonin, calcitonin >100 ng/L, medullary thyroid carcinoma, or multiple endocrine neoplasia-2
    4. Has ever used exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., liraglutide [Victoza®])
    5. Is pregnant
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c from baseline Visit 2 (Week 0) to Visit 7 (Week 24)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    E.5.2Secondary end point(s)
    1. Change in HbA1c
    2. Change in fasting plasma glucose concentration
    3. Proportions of patients achieving HbA1c goals of ≤6.5% and <7.0%
    4. Change in body weight
    5. Change in fasting insulin and C-peptide
    6. Change in beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) as measured by HOMA in EQW patients not taking insulin
    7. Change in lipids
    8. Change in blood pressure
    9. Plasma exenatide concentrations
    10. Proportions of patients discontinuing the study, needing rescue due to failure to maintain glycemic control, and number of rescue episodes
    11. Change in body mass index (BMI)
    12. Change in body weight percentile and height percentile
    13. Safety and tolerability endpoints including incidence of treatment emergent AEs, antibodies to exenatide, physical examinations, laboratory measurements (clinical, chemistry/hematology), and vital sign measurements
    14. Change in calcitonin, pancreatic amylase, and lipase
    15. Change in TSH, free T4, prolactin, cortisol, IGF-1, and DHEAS
    16. Tanner pubertal stage
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 Visit2 to Visit10 & intermediate visits
    2 Visit2 to Visit7, Visit10, & intermediate visits
    3 Visit 7, Visit 10, and each intermediate visit
    4 Visit 2 to Visit 7, Visit 10, & intermediate visits
    5 Visit 2 to Visit 7, Visit 10, & intermediate visits
    6 Visit 2 to Visit 7, Visit 10, & intermediate visits
    7 Visit 2 to Visit 5, Visit 7, Visit 10
    8 Visit 2 to Visit 7, Visit 10, & intermediate visits
    9 Visit 2, Visit 7, Visit 10 & intermediate visits
    10 Visit 7, Visit 10, & intermediate visits
    11 Visit 2 to Visit 7, Visit 10, & intermediate visits
    12. Visit 2 to Visit 7, Visit 10, & intermediate visits
    13 Visit 2 to Visit 7, Visit 10, & intermediate visits
    14 Visit 2 to Visit 5 & Visit 10
    15 Visit 2 to Visit 5, Visit 7, & Visit 10
    16 Visit 2, Visit 5, Visit 7, Visit 9, & Visit 10
    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 No
    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. 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    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
    LVLS. Following V11 (week 62) pts with height increase at least 5 mm between V8 and V11 will enter Extended Safety Follow-up Period (F/U pd). Please refer to Appendix E of protocol for further detail
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months8
    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: 77
    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. of subjects for this age range: 19
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 58
    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 Yes
    F. of subjects incapable of giving consent
    patients 10 to <18 years old, for some their parents/guardian will sign the consent and patients an assent in other cases, the patient will sign consent, whichever is in line with local requirements as age of consent varies per country.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 77
    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)
    subjects who end participation at week 62 or those who enter extended safety follow up will not receive IP and will return to standard care
    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 Decision2016-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
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