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    Summary
    EudraCT Number:2018-000859-40
    Sponsor's Protocol Code Number:AIFA-2016-02364864
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-000859-40
    A.3Full title of the trial
    A randomized, double blind placebo controlled clinical trial to assess the efficacy and safety of sitagliptin on bone measures in women affected by type 2 diabetes. A gender-oriented approach to address a gender-specific frailty. The SLowDOWN (SitagLiptin in Diabetes for Osteoporosis in WomeN) study
    Studio randomizzato, controllato, in doppio cieco per valutare l’efficacia e la sicurezza di sitagliptin su parametri ossei in donne affette da diabete di tipo 2. Un approccio di genere per affrontare una fragilità specifica di genere. Lo studio SLowDOWN (Sitagliptin nel Diabete per l’osteoporosi nella donna).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate efficacy of treatment with sitagliptin on bone parameters in diabetic women
    Studio per valutare l'efficacia di sitagliptin su parametri ossei in donne diabetiche
    A.3.2Name or abbreviated title of the trial where available
    DPP4-Inhibitors and bone metabolism in diabetes
    DPP4-Inibitori e metabolismo osseo nel diabete
    A.4.1Sponsor's protocol code numberAIFA-2016-02364864
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorUMBERTO I - POLICLINICO DI ROMA
    B.1.3.4CountryItaly
    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 supportAIFA - Italian Medicines Agency
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Policlinico Umberto I
    B.5.2Functional name of contact pointDipartimento di Medicina Sperimenta
    B.5.3 Address:
    B.5.3.1Street Addressviale del Policlinico, 155
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number3280060072
    B.5.5Fax number0649974698
    B.5.6E-mailgisella.cavallo@uniroma1.it
    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 TESAVEL - 100 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER (PVC/PE/PVDC/ALU) - 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTesavel
    D.3.2Product code [NA]
    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 FOSFATO MONOIDRATO
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 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
    Diabete di tipo 2
    E.1.1.1Medical condition in easily understood language
    Type-2 diabetes
    Diabete di tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012594
    E.1.2Term Diabetes
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a superiority, double-blinded, randomized, placebo-controlled clinical trial aiming to investigate the safety and efficacy of 52-week sitagliptin 100 mg therapy in improving bone outcomes in women affected by type 2 diabetes.
    In particular, primary objective of this study will be:
    - to test the superiority of sitagliptin 100 mg in add-on to metformin versus placebo + metformin in improving bone mineral density from baseline to end of treatment (week 52), estimated by DXA on lumbar spine and femoral neck.
    Studio clinico di superiorità, in doppio cieco, randomizzato, controllato con placebo, con lo scopo di studiare la sicurezza e l'efficacia della terapia con sitagliptin 100 mg per 52 settimane nel migliorare gli outcomes ossei nelle donne affette da diabete di tipo 2.
    In particolare, l'obiettivo principale di questo studio sarà:
    - testare la superiorità di sitagliptin 100 mg in aggiunta a metformina rispetto a placebo + metformina nel miglioramento della densità minerale ossea dal basale alla fine del trattamento (settimana 52), stimata dalla DXA a livello della colonna vertebrale lombare e del collo del femore
    E.2.2Secondary objectives of the trial
    Secondary endpoints are:
    - to evaluate the association between circulating DPP4 activity and serum markers of bone metabolism at baseline and after 24- and 52-week sitagliptin supplementation.
    - to ascertain whether circulating DPP4 activity is associated with impaired vitamin D availability and, thus, whether chronic DPP4 inhibition induce changes in serum vitamin D levels after treatment.
    - to study the relationship between DPP4 activity and systemic markers of inflammation, closely related to impaired glucose metabolism, at baseline and after 24- and 52-week sitagliptin supplementation
    Gli obiettivi secondari sono:
    - valutare l'associazione tra attività del DPP4 circolante e marcatori sierici del metabolismo osseo al basale e dopo somministrazione di sitagliptin dopo 24 e 52 settimane.
    - valutare se l'attività del DPP4 circolante è associata ad una ridotta disponibilità di vitamina D e, quindi, se l'inibizione cronica del DPP4 induce cambiamenti nei livelli sierici di vitamina D dopo il trattamento.
    - studiare la relazione tra attività del DPP4 e marcatori sistemici di infiammazione, strettamente correlata al metabolismo glucidico alterato, al basale e dopo 24 e 52 settimane di supplementazione con sitagliptin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female subjects = 18 years
    - Diagnosis of Type 2 Diabetes according to American Diabetes Association 2009 criteria
    - Body mass index (BMI) between 20-40 kg/m2
    - Body weight = 120 kg (due to limitations imposed by DXA equipment);
    - HbA1c < 7.5%
    - Treatment with metformin in monotherapy at a stable dose for =12 weeks prior to enrolment
    - Women not of childbearing potential may participate and include those who are:
    I) infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenisis;
    or
    II) postmenopausal – defined as either
    1) A woman 50 to 54 years of age (inclusive) with an intact uterus, not hormone therapy who has had either
    a) cessation of menses for at least 1 years
    or
    b) at least 6 months of spontaneous amenorrhea with a follicle-stimulating hormone > 40 mIU/mL;
    or
    2) a woman 55 or holder not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea;
    or
    3) a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
    - Women of childbearing potential participating:
    I) cannot be pregnant or intend to become pregnant
    II) cannot be breastfeeding
    III) must remain abstinent or use 1 highly effective method of contraception or combination of 2 effective methods of contraception for the entirety of the study
    IV) test negative for pregnancy at the time of screening
    - Donne di età =18 anni
    - Diagnosi di Diabete di tipo 2 secondo i criteri ADA 2009
    - Indice di massa corporeo (BMI) tra 20-40 kg/m2
    - Peso = 120 kg (a causa delle limitazioni imposte dalle apparecchiature DXA)
    - HbA1c < 7.5%
    - Terapia con metformina in monoterapia in dose stabile per un periodo =12 settimane prima dell'arruolamento
    - Donne non potenzialmente fertili, comprendono:
    I) non fertili a causa di interventi di sterilizzazione chirurgica (isterectomia, ooforectomia bilaterale o legatura delle tube), anomalia congenita come l'agenesia Mulleriana;
    o
    II) in stato di post menopausa - definito come:
    1) Una donna di età compresa tra 50 e 54 anni con utero indenne e senza una terapia ormonale e che abbia
    a) cessazione delle mestruazioni da almeno 1 anno
    o
    b) almeno 6 mesi di amenorrea spontanea con valori di ormone follicolo-stimolante (FSH) > 40 mIU / mL;
    oppure
    2) donne di età superiore ai 55 anni non in terapia ormonale, con almeno 6 mesi di amenorrea spontanea;
    oppure
    3) donne di almeno 55 anni di età con diagnosi di menopausa precedente all’inizio della terapia ormonale sostitutiva

    - Possono partecipare allo studio donne potenzialmente fertili:
    I) non intenzionate ad intraprendere una gravidanza
    II) non intenzionate ad effettuare allattamento al seno
    III) intenzionate ad astenersi da rapporti sessuali non protetti o ad utilizzare 1 metodo contraccettivo altamente efficace o una combinazione di 2 metodi contraccettivi efficaci per tutta la durata dello studio
    IV) con test di gravidanza negativo al momento dello screening
    E.4Principal exclusion criteria
    - Treatments known to significantly influence bone metabolism (e.g. bisphosphonates, calcitonin, corticosteroids or hormone replacement therapy)
    - Osteomalacia
    - Pagets disease
    - Hyperparathyroidism
    - Hyperthyroidism
    - Chronic liver failure/cirrhosis
    - Kidney failure
    - Current or history of therapy with antidiabetic agents other than metformin
    - Pregnancy/lactation, childbearing potential women who do not give their consent to remain abstinent or use 1 highly effective method of contraception or combination of 2 effective methods of contraception for the entirety of the study
    - Substance abuse, clinically significant depression or current psychiatric care
    - Refuse or are unable to give informed consent to participate in the study

    Subjects taking vitamin D and/or calcium supplements at enrolment will be instructed to continue this therapy keeping the doses unchanged throughout the entire study
    - Trattamenti noti in grado di influenzare significativamente il metabolismo osseo (ad esempio bifosfonati, calcitonina, corticosteroidi o terapia ormonale sostitutiva)
    - Osteomalacia
    - Malattia di Paget
    - Iperparatiroidismo
    - Ipertiroidismo
    - Insufficienza epatica/cirrosi
    - Insufficienza renale
    - Utilizzo corrente o precedente di terapie con farmaci antidiabetici diversi dalla metformina
    - Gravidanza/allattamento, donne potenzialmente fertili che non acconsentono ad astenersi dai rapporti sessuali non protetti o ad utilizzare 1 metodo contraccettivo altamente efficace o una combinazione di 2 metodi contraccettivi efficaci per tutta la durata dello studio
    - Abuso di sostanze, depressione clinicamente significativa o attuale cura psichiatrica
    - Rifiuto o incapacità di dare il consenso informato a partecipare allo studio

    I soggetti che assumono vitamina D e / o integratori di calcio al momento dell'arruolamento saranno istruiti a continuare la terapia mantenendo le dosi invariate durante l'intero studio.
    E.5 End points
    E.5.1Primary end point(s)
    To test the superiority of sitagliptin 100 mg in add-on to metformin versus placebo + metformin in improving bone mineral density from baseline to end of treatment (week 52), estimated by DXA on lumbar spine and femoral neck
    Testare la superiorità di sitagliptin 100 mg in aggiunta a metformina rispetto a placebo + metformina nel miglioramento della densità minerale ossea dal basale alla fine del trattamento (settimana 52), stimata dalla DXA a livello della colonna vertebrale lombare e del collo del femore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 settimane
    E.5.2Secondary end point(s)
    - to evaluate the association between circulating DPP4 activity and serum markers of bone metabolism at baseline and after 24- and 52-week sitagliptin supplementation; - to ascertain whether circulating DPP4 activity is associated with impaired vitamin D availability and, thus, whether chronic DPP4 inhibition induce changes in serum vitamin D levels after treatment; - to study the relationship between DPP4 activity and systemic markers of inflammation, closely related to impaired glucose metabolism, at baseline and after 24- and 52-week sitagliptin supplementation
    - valutare l'associazione tra attività del DPP4 circolante e marcatori sierici del metabolismo osseo al basale e dopo somministrazione di sitagliptin dopo 24 e 52 settimane; - valutare se l'attività del DPP4 circolante è associata ad una ridotta disponibilità di vitamina D e, quindi, se l'inibizione cronica del DPP4 induce cambiamenti nei livelli sierici di vitamina D dopo il trattamento; - studiare la relazione tra attività del DPP4 e marcatori sistemici di infiammazione, strettamente correlata al metabolismo glucidico alterato, al basale e dopo 24 e 52 settimane di supplementazione con sitagliptin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 and 52 weeks; 24 and 52 weeks; 24 and 52 weeks
    24 e 52 settimane; 24 e 52 settimane; 24 e 52 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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 Information not present in EudraCT
    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
    Both the recruitment and intervention are anticipated to take place over a 36-month period. Study treatment will be administrated along a 52-week period and patients will attend to three site visits: Baseline, 24-week (visit 2) and 52-week (visit 3).
    Sia il reclutamento che l'intervento sono previsti per un periodo di 36 mesi. Il trattamento dello studio sarà gestito per un periodo di 52 settimane e i pazienti parteciperanno a tre visite: baseline, 24 settimane (visita 2) e 52 settimane (visita 3).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days10
    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: 132
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state132
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 132
    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)
    not applicable
    NA
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Euromed Clinical Supply Services s.r.l
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-24
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