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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-000312-28
    Sponsor's Protocol Code Number:P170901J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-000312-28
    A.3Full title of the trial
    Extending time without diabetes after bariatric surgery: a randomized controlled trial comparing the metformin addition or not to standard care
    Prolonger la rémission du diabète après chirurgie de l’obésité : un essai randomisé contrôlé comparant l’ajout de metformine ou non à la prise en charge médicale habituelle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extending time without diabetes after bariatric surgery: a randomized controlled trial comparing the metformin addition or not to standard care
    Prolonger la rémission du diabète après chirurgie de l’obésité : un essai randomisé contrôlé comparant l’ajout de metformine ou non à la prise en charge médicale habituelle
    A.3.2Name or abbreviated title of the trial where available
    DiaBOUT
    DiaBOUT
    A.4.1Sponsor's protocol code numberP170901J
    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 SponsorAPHP / DRCI
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAssistance Publique - Hôpitaux de Paris
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP/DRCI
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144841798
    B.5.5Fax number33144841701
    B.5.6E-mailaurelie.guimfack@aphp.fr
    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.2.1.1.1Trade name METFORMINE 850 mg, comprimé pelliculé
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMETFORMINE 850 mg
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameMetformine 850 mg
    D.3.9.4EV Substance CodeSUB08831MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 complete remission after Bariatric surgery under antidiabetic drug
    Rémission complète du Diabète de type 2 avec traitement antidiabétique, après chirurgie Bariatrique des
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes complete remission after Bariatric surgery under antidiabetic drug
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that metformin increases the proportion of patients with T2D remission compared to standard care among ex-T2D patients operated of BS, after a 3-year period of treatment.
    Démontrer que la metformine augmente la proportion de patients en rémission du DT2 après 3 ans de traitement comparativement à une prise en charge standard sans traitement médicamenteux, chez des patients anciennement diabétiques de type 2 et opérés de chirurgie bariatrique.
    E.2.2Secondary objectives of the trial
    - To assess the proportion of patients with T2D partial or complete remission with metformin compared to standard care in ex-T2D patients operated of BS, after 1 and 2 years of treatment.
    - To assess body weight and metabolic parameters in metformin group versus standard care.
    - To assess tolerance, nutritional status and adherence to metformin in intervention group versus standard care.
    - To assess micro and macroangiopathy at 3 years.
    - To assess quality of life changes from baseline at 1, 2 and 3 years.
    - To assess the accuracy of long term prediction score (i.e. prolonged remission assessed at the end of the study with the Ad-DiaRem score)
    - To explore gut microbiota differences (diversity, composition and function) between metformin treated and non-treated individuals
    - Évaluer la proportion de patients en rémission partielle ou complète du DT2 après 1 et 2 ans de traitement par metformine comparativement à une prise en charge standard sans traitement médicamenteux.
    - Évaluer la perte de poids et les paramètres du syndrome métabolique dans le groupe metformine versus prise en charge standard
    - Évaluer la tolérance, le statut nutritionnel et la compliance au traitement par metformine
    - Évaluer la microangiopathie et macroangiopathie diabétique à 3 ans dans les deux groupes
    - Évaluer les modifications de la qualité de vie à 1, 2 et 3 ans
    - Évaluer l’efficacité du score de prédiction de rémission du diabète long terme (c’est-à-dire la rémission prolongée évaluée à la fin de l’étude avec le score Ad-DiaRem)
    - Explorer les différences de variation du microbiote intestinal entre chez les patients traités par metformine versus les patients sans traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults 18-70 years-old
    - Having undergone gastric bypass or sleeve gastrectomy 12 to 24 months before inclusion
    - “ex-T2D” treated with at least one anti-diabetic drug before bariatric surgery
    - HbA1C < 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months
    - Written consent
    E.4Principal exclusion criteria
    - Known type 1 diabetes
    - Pregnancy and breastfeeding
    - Estimated glomerular filtration rate ≤44 ml/min (MDRD)
    - Known intolerance to metformin
    - Known contraindication to metformin:
    o Acute metabolic acidosis
    o Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent)
    o Acute or chronic disease which could lead to a tissue hypoxia (ex : cardiac insufficiency, respiratory insufficiency, latest myocardial infarction, shock)
    o Hepatocellular insufficiency
    o Alcohol use disorder
    - Medications and medical conditions likely to confound the assessment of diabetes:
    o glucocorticoids treatment
    o renal graft
    o Cushing’s syndrome
    o acromegaly
    o fasting plasma triglyceride > 600 mg/dl despite treatment
    - Patient under legal protection
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with partial or complete T2D remission criteria at three years in T2D patients operated of BS (GB or SG).

    Criteria for diabetes remission assessment will be used as described in 2012 in the American Diabetes Association guidelines (8,9):
    - Complete remission: HbA1c<5.7% and no anti-diabetic medication (except metformin in the experimental group).
    - Partial remission: HbA1c<6.5% and no anti-diabetic medication (except metformin in the experimental group).
    E.5.1.1Timepoint(s) of evaluation of this end point
    LSLV
    E.5.2Secondary end point(s)
    - Proportion of patients with T2D partial or complete remission criteria at 1 and 2 years
    - Proportion of patients with strict complete remission at 3 years
    - Percentage of weight and BMI change at 1,2 and 3 years compared to baseline
    - Level of cardio-metabolic parameters associated to T2D (fasting glycaemia and insulinemia, HOMA-IR, triglycerides and HDL cholesterol, blood pressure) at 1,2 and 3 years compared to baseline
    - Level of nutritional parameters associated with BS (albumin, hemoglobin, iron, serum ferritin, transferrin saturation, calcium, vitamins D and B1, B9, B12) at 1,2 and 3 years compared to baseline
    - Proportion of adverse drug reactions in the intervention group compared to standard care all along the trial (all visits)
    - Adherence level in the intervention group as measured using pill counts (defined as taking at least 80% of assigned study pills in the intervention group) (all visits) and metformin plasmatic dosage at 1,2 and 3 years
    - Number and level of retinopathy, nephropathy and macroangiopathy events at 3 years
    - Quality of life changes assessed by EQ5D auto-questionnaire from baseline to 1, 2 and 3 years
    - 5y-Ad-Diarem score calculated with baseline data (inclusion) to assess clinical outcome at the end of the study
    - Changes in fecal microbiota (diversity, composition and function) from baseline at 1 and 3 years
    E.5.2.1Timepoint(s) of evaluation of this end point
    LSLV
    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 No
    E.6.5Efficacy No
    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 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
    one with medication, control arm without medication
    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 concerned17
    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 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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 350
    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.4.1In the member state350
    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)
    None
    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 Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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