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    Summary
    EudraCT Number:2019-000676-42
    Sponsor's Protocol Code Number:PAP_RI1_2019/1
    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:2020-01-14
    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 number2019-000676-42
    A.3Full title of the trial
    Efficacy of metformin versus sitagliptin on benign thyroid nodules size in type 2 diabetes: a 2-years prospective multicentric study
    Etude multicentrique d’efficacité de la metformine versus la sitagliptine sur l’évolution des nodules thyroïdiens bénins chez les sujets diabétiques de type 2 nouvellement diagnostiqués
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Metformin versus sitagliptin on benign thyroid nodules in type 2 diabetes
    efficacité de la metformine versus la sitagliptine sur les nodules thyroïdiens bénins chez les sujets diabétiques de type 2
    A.3.2Name or abbreviated title of the trial where available
    METNODTHYR
    METNODTHYR
    A.4.1Sponsor's protocol code numberPAP_RI1_2019/1
    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 SponsorUniversity Center Hospital of Guadeloupe
    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 supportGIRCI SOHO
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Center Hospital of Guadeloupe
    B.5.2Functional name of contact pointPETAPERMAL Melanie
    B.5.3 Address:
    B.5.3.1Street AddressROUTE DE CHAUVEL
    B.5.3.2Town/ cityPOINTE A PITRE
    B.5.3.3Post code97159
    B.5.3.4CountryFrance
    B.5.4Telephone number+590590934686
    B.5.6E-mailmelanie.petapermal@chu-guadeloupe.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.2.1.2Country 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 nameMETFORMIN
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    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 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 namesitagliptin
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    newly diagnosed subjects with uncomplicated T2DM and begnin TN of at least 2 cm of size, after pregnancy exclusion if women
    patients nouvellement diagnostiqués présentant un diabète de type 2 sans complications avec des nodules thyroïdiens bénins d'au moins 2 cm de diamètre, n'incluant pas les femmes en post-partum
    E.1.1.1Medical condition in easily understood language
    patients with type 2 diabetes and benign thyroid nodules
    patients atteints de diabète de type 2 et présentant des nodules thyroïdiens bénins
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    compare the efficacy of metformin versus sitagliptin on the evolution of benign thyroid nodules greater than 2 cm in subjects with newly diagnosed type 2 diabetes mellitus.
    Comparer l’efficacité de la metformine versus la sitagliptine sur l’évolution des nodules thyroïdiens bénins de plus de 2cm, chez les sujets ayant un diabète de type 2 nouvellement diagnostiqué.
    E.2.2Secondary objectives of the trial
    - Percentage of thyroid surgery observed in each group at 2 years.
    - Number of new TN (≥ 10mm) after 2 years of follow-up
    - Percentage of metabolic syndrome before and after treatment
    - Proportion of subjects with improvement of the HOMA-IR index and adipokine concentrations
    - Plasmatic TSH, T4 and T3 levels
    - Percentage of IGF-1 and adiponectin receptor expression in thyroid tissues after TN surgery
    - Comparer le recours à la chirurgie thyroïdienne des NT entre les 2 groupes ;
    - Comparer l’efficacité de la metformine à la sitagliptine sur l’incidence des nodules thyroïdiens de plus de 1 cm au cours de l’étude
    - Déterminer l’efficacité de la metformine sur la réduction de l’insulinorésistance clinique : selon les critères du syndrome métabolique selon les critères de l’International Diabetes Federation (IDF), de l’American Heart Association et du National Heart, Lung, and Blood Institute (AHA/NHLBI) de 2009 ;
    - Déterminer l’efficacité de la metformine sur la réduction des marqueurs biologiques de l’insulinorésistance : Index HOMA et concentrations sériques des adipokines ;
    - Evaluer l’impact des traitements sur la fonction thyroïdienne
    - déterminer, dans la sous population des sujets opérés de la thyroïde, l’expression des récepteurs de l’IGF-1 et de l’adiponectine dans les 2 groupes afin d’analyser la relation entre ces expressions et la réponse aux thérapeutiques.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with T2DM aged 18 to 65 years;
    - Uncomplicated T2DM, evolving for less than 3 years;
    - Patients with HbA1c levels between 7 and 8% (after the run-in period)
    - Patients with at least one TN ≥ 2 cm non-cystic, whose benignity will be confirmed by a fine-needle aspiration cytology performed twice regardless of ultrasound TIRADS score;
    - Naive subjects of any treatment: never received an anti-diabetic treatment OR received an anti-diabetic treatment of less than 30 days since diagnosis OR did not receive an anti-diabetic treatment during the 30 days before screening;
    - Patients with a creatinine clearance > 60 ml/min;
    - Informed and written consent signed by the patient and the investigator;
    - Affiliation to the national social health system or equivalent.
    1. Patients diabétiques de type 2 de plus de 18 ans, des deux sexes et de moins de 65 ans
    2. Diabète de type 2 non compliqué, évoluant depuis moins de 3 ans
    3. Sujets naïfs de tout traitement : n’ayant jamais reçu de traitement antidiabétique OU ayant reçu un traitement antidiabétique d’une durée inférieure à 30 jours depuis le diagnostic OU n’ayant pas reçu un traitement antidiabétique durant les 30 jours avant le screening.
    4. Patients sans insuffisance rénale (clairance de la créatinine > 60ml/mn)
    5. Affiliation à un régime de sécurité social ou équivalent
    6. Patients informés et ayant donné leur consentement libre, éclairé et écrit
    7. Patients ayant au moins un NT ≥ 2 cm non kystique pur, dont la bénignité sera confirmée par une cytoponction réalisée à 2 reprises quel que soit le TIRADS échographique
    8. HbA1c entre 7 et 8% après une phase de run-in de 1 mois avec insuline glargine U300 U/j
    E.4Principal exclusion criteria
    - Subjects without adequate or impaired decisional abilities for consent to research and placed under guardianship, curatorship or safeguard of justice
    - Pregnant or breastfeeding woman
    - Woman of childbearing potential without effective contraception (estroprogestative, presentative, intrauterine device)
    - Suspect thyroid nodules in ultrasound (TIRADS 4 to 5) with confirmation after a fine-needle aspiration cytology;
    - Thyroid function abnormalities or a history of thyroid disease;
    - Thyroid nodules whose size or symptoms (compressive signs) require surgery
    - Urinary iodures <100ug /L
    - Thyroid autoimmunity: positive anti-peroxidase, thyroglobulin or anti-TSH receptors antibodies
    - Levothyroxine treatment
    - History of cervical radiotherapy or thyroid surgery
    - Type 1 diabetes
    - Insulin deficiency
    - History of hypersensitivity to one of the active substances
    - History of pancreatitis
    - Obesity linked to endocrine disease
    - Presence of severe complications of T2DM (ischemic heart disease, heart failure with reduced left ventricular ejection fraction, severe lower extremity arteritis, gangrene, retinopathy, end-stage renal failure, cerebrovascular accident)
    - HbA1c levels > 8% after the run-in period
    - Liver diseases (liver failure, cirrhosis, viral hepatitis B or C)
    - Acute alcoholic intoxication, chronic alcoholism
    - Psychiatric diseases (depression, schizophrenia)
    - Neurological diseases (epilepsy, demyelinating diseases, etc.)
    - Treatment influencing the morphology or thyroid function: corticosteroids, lithium etc. ...
    - Acute conditions that may impair renal function such as: dehydration, severe infection…
    1. Sujets placés sous tutelle, curatelle ou sauvegarde de justice
    2. Femme enceinte ou allaitante
    3. Femme en âge de procréer sans contraception efficace (Critères HAS)
    4. Anomalies de la fonction thyroïdienne (hyperthyroïdie ou hypothyroïdie) ou antécédents de pathologies thyroïdiennes exceptée la lobectomie pour NT bénin
    5. Nodules thyroïdiens suspects en échographie (TIRADS 4 à 5) avec confirmation après cytoponction
    6. Nodules thyroïdiens symptomatiques (signes compressifs) nécessitant une chirurgie
    7. Iodurie < 100ug/l
    8. Auto-immunité thyroïdienne positive : anticorps anti peroxydase et/ou thyroglobuline, anti-récepteurs de la TSH
    9. Traitement par lévothyroxine
    10. Antécédents de radiothérapie cervicale ou de chirurgie thyroïdienne
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients in each group who had a decrease of at least 20% in one or more nodules larger than 2 cm to 2 years
    Le pourcentage de patients dans chaque groupe ayant eu une diminution d’au moins 20% d’un ou de plusieurs nodules de plus de 2 cm à 2 ans.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 ans
    E.5.2Secondary end point(s)
    - percentage of thyroid surgery observed in each group at 2 years. During follow-up, surgery will be indicated in the presence of an NT having increased in size and associated with either 1 / symptoms of local compression, or 2 / a suspicion of malignancy at the needle aspiration performed in the presence of ultrasound criteria TIRADS 4 or 5;
    - The number of new nodules (≥ 10mm) in ultrasound at 2 years;
    - The percentage of metabolic syndrome before and after treatment;
    - HOMA index variations and adipokine concentrations after 2 years;
    - Changes in plasma concentrations of TSH, T4, T3 after 2 years;
    - The percentage of expression of IGF-1 and adiponectin receptors in NT operated in group 1 compared to group 2.
    - Le pourcentage de chirurgie thyroïdienne observé dans chaque groupe à 2 ans. Au cours du suivi, la chirurgie sera indiquée en présence d’un NT ayant augmenté de taille et associé à soit 1/ des symptômes de compression locale, soit 2/ une suspicion de malignité à la cytoponction réalisée en présence de critères échographiques TIRADS 4 ou 5 ;
    - Le nombre de nouveaux nodules (≥ 10mm) en échographie à 2 ans ;
    - Le pourcentage de syndrome métabolique avant et après traitement ;
    - Les variations d’index HOMA et des concentrations d’adipokines après 2 ans ;
    - Les variations des concentrations plasmatiques de TSH, T4, T3 après 2 ans ;
    - Le pourcentage d’expression des récepteurs de l’IGF-1 et de l’adiponectine au sein des NT opérés dans le groupe 1 comparé au groupe 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 ans
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    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
    dernière visite du dernier patient
    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: 90
    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 state90
    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
    Aucun
    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 Decision2023-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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