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    Summary
    EudraCT Number:2009-012652-24
    Sponsor's Protocol Code Number:SYR-322MET_302
    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:2010-01-12
    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 number2009-012652-24
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the
    Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in
    Subjects with Type 2 Diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the effectiveness and safety of of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects with Diabetes
    A.4.1Sponsor's protocol code numberSYR-322MET_302
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Global Research and 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 Global Research and 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 organisationPPD
    B.5.2Functional name of contact pointDavid Brummell
    B.5.3 Address:
    B.5.3.1Street AddressGranta Park
    B.5.3.2Town/ cityGreat Abington
    B.5.3.3Post codeCB21 6GQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441295 670 940
    B.5.5Fax number441223 898 909
    B.5.6E-mailDavid.Brummell@ppdi.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
    D.3.9.1CAS number 850649-62-6
    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
    D.3.9.1CAS number 850649-62-6
    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.IMP: 3
    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 Metformin 500mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMetformin
    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 INNMetformin hydrochloride
    D.3.9.1CAS number 1115-70-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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 II diabetes mellitus (T2DM)
    E.1.1.1Medical condition in easily understood language
    A metabolic disease in which a person has high blood sugar, either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced.
    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 14.0
    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 evaluate the efficacy of combination of alogliptin BID plus metformin BID as compared with alogliptin BID alone or metformin BID alone on HbA1c change from Baseline at Week 26 (or at time of discontinuation of double-blind study medication or hyperglycemic rescue).
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy comparison between alogliptin BID alone and alogliptin QD alone on HbA1c change from Baseline at Week 26.
    - To evaluate other measures of glycemic control including change from Baseline of fasting plasma glucose at all visits, and HbA1c at visits other than Week 26.
    Safety objective:
    To evaluate the safety by adverse events, hypoglycemic events, clinical laboratory parameters, ECG
    readings, physical examination, and vital signs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility is determined according to the following criteria:
    1. Male or female subjects, 18 to 80 years of age, with a historical diagnosis of T2DM.
    2. The subject has been treated with diet and exercise for at least 2 months prior to Screening and has an HbA1c concentration between 7.5% and 10.0%, inclusive at Screening.
    3. The subject has received less than 7 days of any antidiabetic medication within 2 months prior to Screening.
    4. Body mass index (BMI) ≥23 kg/m2 and ≤45 kg/m2 (except for Asian or Asian descendant subjects for whom the range is between 20 and 35 kg/ m2, inclusive).
    5. Fasting C-peptide concentration ≥0.8 ng/mL (≥0.26 nmol/L).
    6. Subjects regularly using other, nonexcluded, medications must be on a stable dose for at least the 4 weeks prior to Screening; however, PRN (as needed) use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
    7. A female subject of childbearing potential and males who are sexually active agree to routinely use adequate contraception from Screening throughout the duration of the study.
    NOTE: Women NOT of childbearing potential are defined as those who have been surgically sterilized (ie, hysterectomy, bilateral salpingo-oophorectomy, bilateral tubal ligation) or who are postmenopausal (defined as at least 45 years of age AND 1 year since last regular menses). Acceptable methods of contraception are defined in Section 9.1.12 of the Protocol.
    8. Subject is able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete subject diaries.
    9. Subject is able and willing to provide written informed consent.
    10. The subject is capable of understanding and complying with the protocol requirements, including scheduled clinic appointments.
    E.4Principal exclusion criteria
    Any subject who meets any of the following criteria will not qualify for entry into the study:
    1. Hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening Visit.
    2. Subject has a history of any hemoglobinopathy that may affect determination of HbA1c.
    3. Subject has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
    4. Subject has a history of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
    5. Subject has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
    6. Subject has systolic blood pressure ≥150 mmHg and /or diastolic pressure 90 mmHg at Screening visit.
    7. Subject has New York Heart Association (NYHA) Class III to IV heart failure (See
    Appendix E) regardless of therapy. (Currently treated subjects who are stable at NYHA Class I or II are candidates for the study.)
    8. Subject has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 90 days prior to Screening.
    9. Alanine aminotransferase (ALT) >3x upper limit of normal at Screening.
    10. Subject has a history of alcohol or substance abuse with the 2 years prior to Screening.
    11. Serum creatinine ≥ 1.5 mg/dL for males or ≥1.4 mg/dL for females, or creatinine clearance <60 mL/min based on calculation by central lab using the MDRD approximation at Screening.
    12. Subject has 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).
    13. Subject has a history of infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
    14. Subject has any major illness or debility that in the investigator’s opinion prohibits the subject from completing the study.
    15. Subject has received any investigational drug within the 90 days prior to Screening.
    16. Subject has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors, metformin, or related compounds.
    17. If female, the subject is pregnant or lactating or intending to become pregnant during or within 1 month after participating in this study. Subject has used oral or systemically injected glucocorticoids (including intra-articular injection) or use of weight-loss drugs within 2 months prior to screening. (Inhaled or topical corticosteroids are allowed.)
    18. The subject is unable to understand verbal or written English, or any other language for which a certified translation of the approved informed consent is available.
    19. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, and sibling) of a study site employee who is involved in conduct of this study.
    20. Subject has used oral or systemically injected glucocorticoids (including intra-articular injection) or use of weight-loss drugs within 2 months prior to screening. (Inhaled or topical corticosteroids are allowed.)
    E.5 End points
    E.5.1Primary end point(s)
    HbA1c change from Baseline at Week 26.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26.
    E.5.2Secondary end point(s)
    Change from Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20.
    Change from Baseline in fasting plasma glucose at Weeks 1, 2, 4, 8, 12, 16, 20, and 26.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20.
    Change from Baseline in fasting plasma glucose at Weeks 1, 2, 4, 8, 12, 16, 20, and 26.
    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 Yes
    E.6.6Pharmacokinetic No
    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.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 trial3
    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 EEA45
    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
    Czech Republic
    Hungary
    India
    Israel
    Lithuania
    Mexico
    Poland
    Romania
    Russian Federation
    Slovakia
    Ukraine
    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
    The end of the trial is defined as the last follow up visit of the last subject participating in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.2.1Number of subjects for this age range: 710
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 790
    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)
    As per protocol
    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 Decision2010-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-30
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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