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    Summary
    EudraCT Number:2007-000240-27
    Sponsor's Protocol Code Number:01-06-TL-SYR472-007
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-04
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2007-000240-27
    A.3Full title of the trial
    A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter
    Study to Evaluate Weekly Treatment with SYR-472 in Subjects with Type 2 Diabetes.
    A.3.2Name or abbreviated title of the trial where available
    TAK472-007
    A.4.1Sponsor's protocol code number01-06-TL-SYR472-007
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Global Research & 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameSYR-472
    D.3.2Product code SYR-472
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSYR-472
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameSYR-472
    D.3.2Product code SYR-472
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSYR-472
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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 is to evaluate the efficacy of SYR-472 treatment on glycosylated hemoglobin (HbA1c) change from Baseline in subjects with type 2 diabetes mellitus who have not previously achieved adequate glycemic control with either lifestyle modification (diet/exercise) or metformin oral antidiabetic monotherapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the treatment effects of SYR-472 on other parameters of glycemic control, pancreatic function, and lipid metabolism, as well as the safety/tolerability of the drug. A sparse sampling approach will be used to determine SYR-472 plasma concentration pharmacokinetics and the percentage inhibition of dipeptidyl peptidase-4 enzyme (DPP-4) activity pharmacodynamics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is male or female, aged 18 to 80 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus.
    2. The subject is capable of understanding and complying with the protocol requirements.
    3. The subject or the subject’s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
    4. The subject has undergone less than 7 days of any antidiabetic therapy except lifestyle modification (diet/exercise) within 8 weeks prior to Screening; or has received metformin monotherapy for at least 8 weeks prior to Screening and maintained a stable daily dose of metformin for at least 12 weeks prior to randomization.
    5. The subject receiving metformin monotherapy at randomization must have been at least 75% compliant with his or her regimen during the Run-in/Stabilization Period as determined by subject diary and investigator assessment.
    6. The subject has received no treatment with antidiabetic agents other than metformin within the 8 weeks prior to Screening. (Exception: if the subject has received other antidiabetic therapy for less than 7 days within the 8 weeks prior to Screening.)
    7. The subject has an HbA1c concentration between 7.0% and 10.0%, inclusive, at Screening and at the Week -1 Visit.
    NOTE: If the subject does not qualify based on this criterion, the assessment may be repeated on a weekly basis, for a maximum of 2 additional weeks.
    8. The subject has a body mass index (BMI) between 23 and 45 kg/m2 .
    9. The subject’s fasting C-peptide concentration is ≥0.8 ng/mL (≥ 0.26 nmol/L).
    10. The subject’s FPG concentration is <275 mg/dL (<15.27 mmol/L) at Screening and at the Week -1 Visit.
    NOTE: If the subject does not qualify based on this criterion, the assessment may be repeated on a weekly basis, for a maximum of 2 additional weeks.
    11. If the subject regularly uses other nonexcluded medications, he or she must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter (OTC) medications is allowed at the discretion of the investigator.
    12. The subject has a systolic blood pressure reading of <160 mm Hg and a diastolic pressure reading of <100 mm Hg.
    13. The subject has a hemoglobin value ≥12 g/dL (≥120 g/L) for men and ≥10 g/dL (≥100 g/L) for women.
    14. The subject’s alanine aminotransferase level is ≤3 times the upper limit of normal (ULN).
    15. A male subject has a serum creatinine value of <1.5 mg/dL (<133 μmol/L); a female subject has a serum creatinine value of <1.4 mg/dL (<124 μmol/L).
    16. The subject has a urine albumin/creatinine ratio of <1000 μg/mg at Screening.
    17. The subject has a thyroid-stimulating hormone level ≤ the ULN range and the subject is clinically euthyroid.
    18. A female subject must be neither pregnant nor lactating. A female subject of childbearing potential must have a negative human chorionic gonadotropin (hCG) pregnancy test at Screening and within 1 day prior to administration of the first dose of study medication.
    19. A female subject of childbearing potential who is sexually active must agree to use adequate contraception (as defined in the informed consent form) from Screening and throughout the duration of the study.
    20. The subject is able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor.
    21. The subject has no major illness or debility that in the investigator’s opinion prohibits the subject from completing the study.
    E.4Principal exclusion criteria
    1. The subject is being concurrently treated with antidiabetic therapy other than metformin and lifestyle intervention.
    2. The subject has a history of cancer, other than squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia [CIN I] or CIN II is allowed.)
    3. The subject has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
    4. The subject has a history of treated diabetic gastric paresis.
    5. The subject has New York Heart Association class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at class I or II are candidates for the study.
    6. The subject has a history of coronary angioplasty, underwent coronary stent placement or coronary bypass surgery, or suffered a myocardial infarction, or stroke within the 6 months prior to Screening.
    7. The subject has a history of any hemoglobinopathy that may affect determination of HbA1c.
    8. The subject has a history of infection with human immunodeficiency virus.
    9. The subject has a history of a psychiatric disorder that in the investigator’s opinion will affect the subject’s ability to participate in the study.
    10. The subject has a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) or substance abuse (defined as illicit drug use) within the 2 years prior to Screening.
    11. The subject has ingested or received systemically injected glucocorticoids within the 3 months prior to randomization. Inhaled corticosteroids are allowed.
    12. The subject has used prescription or over-the-counter weight-loss drugs within the 3 months prior to randomization.
    13. The subject has received any investigational drug within the 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening.
    14. The subject has received previous treatment in an investigational study of SYR-472.
    15. The subject has a known hypersensitivity to any compound related to SYR-472.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the study is the change in HbA1c from Baseline (Day 1) to Week 12.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 161
    F.4.2.2In the whole clinical trial 369
    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)
    Expected normal treatment.
    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 Decision2007-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-13
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