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    Summary
    EudraCT Number:2009-011221-13
    Sponsor's Protocol Code Number:SYR-322_104
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-09-30
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2009-011221-13
    A.3Full title of the trial
    A Comparative, Randomized, Open-Label, Multi-Center, Single Dose Pharmacokinetic, Pharmacodynamic and Safety Study of Alogliptin (12.5 mg and 25 mg) Between Children, Adolescents, and Adults with Type 2 (Non-Insulin Dependent) Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics, Pharmacodynamics and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus
    A.4.1Sponsor's protocol code numberSYR-322_104
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00957268
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1111-7810
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/20/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Global Research & Development Center, Inc.
    B.1.3.4CountryUnited States
    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 Global Research & Development Center, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Global Research & Development Center, Inc.
    B.5.2Functional name of contact pointStudy Registration Call Centre
    B.5.3 Address:
    B.5.3.1Street AddressOne Takeda Parkway
    B.5.3.2Town/ cityDeerfield
    B.5.3.3Post codeIL 60015
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007782860
    B.5.5Fax number001800953-3071
    B.5.6E-mailmedicalinformation@tpna.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 No
    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
    D.3.2Product code SYR-322
    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 benzoate
    D.3.9.1CAS number 85064962-6
    D.3.9.2Current sponsor codeSYR-322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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.IMP: 2
    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 No
    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
    D.3.2Product code SYR-322
    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 benzoate
    D.3.9.1CAS number 85064962-6
    D.3.9.2Current sponsor codeSYR-322
    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
    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
    Type 2 diabetes
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II 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
    To determine the pharmacokinetic and pharmacodynamic profiles, safety, and tolerability of a single dose of alogliptin 12.5 mg and 25 mg in subjects with type 2 diabetes mellitus who are between 10 to 17 years old and adult subjects with type 2 diabetes mellitus
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for children and adolescent participants (between 10 and 17 years of age):
    • Is capable of understanding an informed consent form (ICF) or assenting to participate. The parent or legal guardian of the participant must be able to understand and sign a written ICF prior to the initiation of any study procedures.
    • Weighs at least 36 kg (79 pounds) and has a Screening Body Mass Index of at least 18 kg/m2.
    • Participants must have a diagnosis of Type 2 Diabetes Mellitus (non-insulin dependent) based on diagnostic criteria of the American Diabetes Association. Criteria include:
    a) fasting plasma glucose level of greater than or equal to 126 mg/dL where fasting is defined as no caloric intake for at least 8 hours, or
    b) 2-hour plasma glucose level of greater than or equal to 200 mg/dL during an oral glucose tolerance test, or
    c) random plasma glucose level of greater than or equal to 200 mg/dL, or
    d) glycated Hemoglobin greater than or equal 6.5%.
    • Diagnosis can be historical (documented), or subjects can be diagnosed for this study.
    • Subjects must have a fasting serum C-peptide concentration greater than or equal to 0.8 ng/mL (greater than or equal to 0.26 nmol/L) at Screening Visit only.
    • Subjects may be taking concomitant metformin if the dose has been stable for at least 30 days prior to Day 1.

    Inclusion criteria for gender and race matched adult participants (between 18 and 65 years of age):
    • Weighs at least 50 kg (110 pounds) and has a Screening Body Mass Index between 23 kg/m2 and 45 kg/m2 (except for Asian or Asian-descendant subjects for whom the range is between 20 kg/m2 and 35 kg/m2), inclusive for gender and race matched Type 2 Diabetes Mellitus adult subjects only.
    • Subjects must have a diagnosis of Type 2 Diabetes Mellitus (non-insulin dependent) based on diagnostic criteria of the American Diabetes Association. Criteria include:
    a) Fasting plasma glucose level of greater than or equal to 126 mg/dL where fasting is defined as no caloric intake for at least 8 hours, or
    b) 2-hour plasma glucose level of greater than or equal to 200 mg/dL during an oral glucose tolerance test, or
    c) random plasma glucose level of greater than or equal to 200 mg/dL, or
    d) glycated Hemoglobin greater than or equal 6.5%.
    • Diagnosis can be historical (documented) or subjects can be diagnosed for this study.
    • May be taking concomitant metformin if the dose has been stable for at least 30 days prior to Day 1.
    • May be taking statin or antihypertensive drugs if the dose has been stable for at least 30 days prior to Day 1.

    Inclusion criteria for all participants:
    • Female participants of childbearing potential and male subjects who are sexually active agree to routinely use adequate contraception from Screening until 30 days after receiving the dose of study drug.
    • Must have a negative urine test result for selected substances of abuse (including alcohol and cotinine) at Screening and Check-in (Day -1).
    • Has clinical chemistry, hematology, and complete urinalysis (fasted for at least 8 hours) results within the reference range for the testing laboratory (except results associated with Type 2 Diabetes Mellitus) unless the out-of-range results are deemed not clinically meaningful by the investigator or sponsor.
    • Has a negative test result for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (anti-HCV), and no known history of human immunodeficiency virus (HIV).
    E.4Principal exclusion criteria
    • Is currently participating in another investigational study or has taken an investigational drug within 30 days prior to Day 1.
    • Received alogliptin previously.
    • Received or donated blood or blood products within 30 days prior to Screening or plans to donate blood during the study.
    • Has a known hypersensitivity to alogliptin or related compounds.
    • Has a history of drug abuse or a history of alcohol abuse within 1 year prior to study Day 1.
    • Has had an acute, clinically significant illness (excluding Type 2 Diabetes Mellitus) within 30 days prior to study Day 1.
    • Has any other condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
    • Has a history or clinical manifestations of significant metabolic (excluding Type 2 Diabetes Mellitus), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, musculoskeletal or psychiatric disorder.
    • Has a hemoglobin value less than 12 g/dL.
    • Has a systolic blood pressure greater than 140 mm Hg or has a diastolic blood pressure greater than 90 mm Hg at Screening or Check-in (Day -1).
    • Adult subject has an alanine aminotransferase or aspartate aminotransferase level greater than 2 times the upper limit of normal active liver disease, or jaundice at the Screening Visit or on Check-in (Day -1).
    • Pediatric subject has an alanine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal at the Screening Visit or on Check-in (Day -1).
    • Has a serum creatinine level greater than 1.5 mg/dL.
    • Has a creatinine clearance less than 50 mL/min (normalized to body surface area of 1.73 m2).
    • Has a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or nonperipheral vascular surgery within 6 months prior to Day 1.
    • Has a history or presence of a clinically significant abnormal 12-lead Electrocardiogram result as determined by the investigator or Takeda Global Research and Development at Screening or Check-in (Day -1).
    • Has a history of cancer, other than basal cell carcinoma or Stage I squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to the first dose of study drug.
    • If female, subject is pregnant or lactating or intending to become pregnant before, during, or within 30 days after receiving study drug.
    • If male, subject intends to impregnate others during the study or for 30 days after receiving study drug.
    • Has consumed or is unable to abstain from consumption of products containing alcohol, caffeine, or xanthine, and food or beverages containing grapefruit juice or Seville-type oranges within 72 hours prior to study Day 1 and for the duration of the study.
    • Used any tobacco (ie, nicotine) products within 6 weeks prior to study Day 1, and is unwilling to abstain from these products for the duration of the study.
    • Has used any nutraceutical preparations within 28 days prior to study Day 1.
    • Is currently taking ketoconazole, fluconazole, gemfibrozil, rifampin or carbamazepine or taken within 28 days prior to Check-in (Day -1).
    • Has poor peripheral venous access.
    • Subject has a medical history of clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes or secondary forms of diabetes including MODY.
    E.5 End points
    E.5.1Primary end point(s)
    Plasma pharmacokinetic endpoints for alogliptin are maximum observed plasma concentration (Cmax), time to reach Cmax (Tmax), and area under the plasma concentration-time curve from time 0 to infinity (AUC[0-inf])
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1
    E.5.2Secondary end point(s)
    Pharmacodynamic secondary endpoints for DPP-4 inhibition and GLP-1 are area under the plasma effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]), maximum observed effect (Emax), time to reach maximum observed effect (Tmax), and observed effect at 24 hours after dosing (E24)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    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) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Adults
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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: 24
    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: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 23
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 48
    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)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation None
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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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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