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    Summary
    EudraCT Number:2011-005980-26
    Sponsor's Protocol Code Number:MAAS
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-13
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-005980-26
    A.3Full title of the trial
    Metformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke - a multicenter, randomized, open-label phase II trial
    De veiligheid, verdraagbaarheid en effectiviteit van metformine en sitagliptine bij patiënten met een recente TIA of klein herseninfarct en een gestoorde glucosetolerantie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke - a multicenter, randomized, open-label phase II trial
    De veiligheid, verdraagbaarheid en effectiviteit van metformine en sitagliptine bij patiënten met een recente TIA of klein herseninfarct en een gestoorde glucosetolerantie.
    A.3.2Name or abbreviated title of the trial where available
    MAAS trial
    MAAS trial
    A.4.1Sponsor's protocol code numberMAAS
    A.5.4Other Identifiers
    Name:Nederlands Trial RegisterNumber:3196
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.2Product code metformin
    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
    D.3.9.1CAS number 657-24-9
    D.3.9.2Current sponsor codemetformin
    D.3.9.4EV Substance CodeSUB08831MIG
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namesitagliptin
    D.3.2Product code sitagliptin
    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 INNSITAGLIPTIN
    D.3.9.1CAS number 790712-60-6
    D.3.9.2Current sponsor codesitagliptin
    D.3.9.4EV Substance CodeSUB25227
    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
    Stroke
    Transient ischemic attack
    Impaired glucose tolerance
    Herseninfarct
    TIA
    Gestoorde glucose tolerantie
    E.1.1.1Medical condition in easily understood language
    Stroke
    Transient ischemic attack
    Impaired glucose tolerance
    Herseninfarct
    TIA
    Gestoorde glucose tolerantie
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10042244
    E.1.2Term Stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052426
    E.1.2Term Glucose intolerance
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10044391
    E.1.2Term Transient ischemic attacks
    E.1.2System Organ Class 10029205 - Nervous system 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 compare the effectiveness, feasibility and safety of both metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance.
    Vergelijken van de effectiviteit, uitvoerbaarheid en veiligheid vergelijken van zowel metformine en sitagliptine bij patiënten met een TIA of een klein herseninfarct en gestoorde glucosetolerantie.
    E.2.2Secondary objectives of the trial
    To assess whether a slow increase in dose of metformin over a 6 week period and better support and information on this treatment will reduce the incidence of gastrointestinal side effects in these patients, and whether it will improve treatment compliance.
    Nagaan of langzamer opbouwen van metformine en betere informatievoorziening leidt tot minder bijwerkingen en een betere therapietrouw en of sitagliptine een goede alternatieve behandeling is voor metformine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible for inclusion if they are 18 years or older, have a clinical diagnosis of TIA, amaurosis fugax or minor ischemic stroke (defined as a modified Rankin scale (mRS) score of 3 or less) within the previous 6 months, and have impaired glucose tolerance, defined as 2-hour post-load glucose levels between 7.8 and 11.0 mmol/L.
    Patiënten komen voor inclusie in aanmerking als ze 18 jaar of ouder zijn, een klinische diagnose van TIA, amaurosis fugax of klein herseninfarct (gedefinieerd als een modified Rankin Scale (mRS) score van 3 of lager) in de afgelopen 6 maanden en gestoorde glucosetolerantie hebben (gedefinieerd als een glucose na belasting tussen 7.8 en 11.0 mmol/L).
    E.4Principal exclusion criteria
    Patients will be excluded if they are known to have diabetes mellitus or a history of diabetic ketoacidosis, if they have symptoms of type 1 diabetes mellitus, signs of renal impairment (creatinin of 135 μmol/L or higher for men, and 110 μmol/L or higher for women), known liver disease or disturbed liver function tests (alanine amino transferase, aspartate amino transferase, alkaline phosphatase, or γ glutamyl transferase increased to more than twice the upper limit of typical values), a history of lactic acidosis, heart failure requiring pharmacological therapy, pancreatitis or chronic hypoxic lung disease, if they use digoxin or in case of pregnancy or breast feeding.
    Patiënten zullen worden geëxcludeerd als er sprake is van diabetes mellitus of diabetische keto-acidose in de voorgeschiedenis, symptomen passend bij type 1 diabetes mellitus, tekenen van nierfunctiestoornissen (creatinine van 135µmol/L of hoger bij mannen, en 110µmol/L of hoger bij vrouwen), een bekende leveraandoening of gestoorde leverfunctiestoornissen (alanine amino transferase, aspartate amino transferase, alkaline phosphatase, of γ glutamyl transferase meer dan twee keer zo hoog dan het bovenlimiet van de normaalwaarde), lactaatacidose in de voorgeschiedenis, hartfalen waarvoor medicamenteuze behandeling nodig is, pancreatitis, chronische hypoxische longaandoening, digoxine gebruik, zwangerschap of borstvoeding.
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameters:
    - the tolerability of metformin and sitagliptin, assessed as number of patients still on treatment after 6 months.
    - the safety of treatment with metformin and sitagliptin, assessed as number of adverse events and serious adverse events after 6 months.
    - the effect on 2-hour post-load glucose levels at 6 months, assessed as the baseline adjusted difference in 2-hour post-load glucose levels.
    De primaire uitkomstmaten zijn:
    - de verdraagbaarheid van metformine en sitagliptine (bepaald door het aantal patiënten die na 6 maanden nog steeds de medicatie gebruiken).
    - de veiligheid van de behandeling met metformine en sitagliptine (bepaald door het aantal adverse events en serious adverse events na 6 maanden)
    - het effect op glucose na belasting na 6 maanden (bepaald door het verschil in glucose na belasting t.o.v. baseline)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - the tolerability of metformin and sitagliptin: after 6 months.
    - the safety of treatment with metformin and sitagliptin: after 6 months.
    - the effect on 2-hour post-load glucose levels: at 6 months
    - de verdraagbaarheid van metformine en sitagliptine: na 6 maanden
    - de veiligheid van de behandeling met metformine en sitagliptine: na 6 maanden
    - het effect op glucose na belasting: na 6 maanden
    E.5.2Secondary end point(s)
    Secondary study parameters:
    - the effect on 2-hour post-load glucose levels at 3 months, assessed as the baseline adjusted difference in 2-hour post-load glucose levels
    - the effect on fasting glucose levels at 3 and 6 months, assessed as the baseline adjusted difference in fasting glucose levels
    - the effect on body mass index (BMI) and waist circumference at 6 months
    - the percentage of patients with a normal glucose tolerance at 6 months
    Secundaire uitkomstmaten zijn:
    - het effect op glucose na belasting na 3 maanden (bepaald door het verschil in glucose na belasting t.o.v. baseline)
    - het effect op nuchter glucose na 3 en na 6 maanden (bepaald door het verschil in glucose t.o.v. baseline)
    - het effect op body mass index (BMI) en middelomtrek na 6 maanden
    - percentage patiënten met een normale glucose tolerantie na 6 maanden
    E.5.2.1Timepoint(s) of evaluation of this end point
    - the effect on 2-hour post-load glucose levels: at 3 months
    - the effect on fasting glucose levels: at 3 and 6 months
    - the effect on body mass index (BMI) and waist circumference: at 6 months
    - the percentage of patients with a normal glucose tolerance: at 6 months
    - het effect op glucose na belasting: na 3 maanden
    - het effect op nuchter glucose: na 3 en na 6 maanden
    - het effect op body mass index (BMI) en middelomtrek: na 6 maanden
    - percentage patiënten met een normale glucose tolerantie: na 6 maanden
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    geen behandeling
    no treatment
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Laatste bezoek laatste proefpersoon
    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 months0
    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 months0
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-02-13. Yes
    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 state100
    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 metformin or sitagliptin will be stopped after 6 months, unless the patient developped diabetes mellitus.
    De metformine of sitagliptine zal gestopt worden na 6 maanden, tenzij de patient diabetes mellitus heeft ontwikkeld.
    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 Decision2012-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-04
    P. End of Trial
    P.End of Trial StatusOngoing
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