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    The EU Clinical Trials Register currently displays   36111   clinical trials with a EudraCT protocol, of which   5936   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-004527-32
    Sponsor's Protocol Code Number:SITADS
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-004527-32
    A.3Full title of the trial
    Pilot randomised controlled trial of SITAgliptin for Depressive Symptoms in type 2 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sitagliptin is an established diabetes drug medication that acts primarily by stimulating the body’s ability to release insulin, leading to a lowering of blood sugar levels. This clinical trial will examine whether treatment with Sitagliptin can improve both depression and type 2 diabetes together
    A.3.2Name or abbreviated title of the trial where available
    SITADS Study
    A.4.1Sponsor's protocol code numberSITADS
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportKHP BRC Experimental Medicine Pilot Project Award
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProf Khalida Ismail
    B.5.3 Address:
    B.5.3.1Street AddressWeston Education Centre, Department of Psychological Medicine, King’s College London
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402078483545
    B.5.5Fax number004402078485048
    B.5.6E-mailkhalida.2.ismail@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKings College Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportKHP BRC Experimental Medicine Pilot Project Award
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProf Khalida Ismail
    B.5.3 Address:
    B.5.3.1Street AddressWeston Education Centre, Department of Psychological Medicine, King’s College London,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402078483545
    B.5.5Fax number004402078485048
    B.5.6E-mailkhalida.2.ismail@kcl.ac.uk
    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 Januvia (Sitagliptin)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    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 nameJanuvia (Sitagliptin)
    D.3.4Pharmaceutical form Capsule, hard
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Depression in type 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Depression in type 2 diabetes
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012378
    E.1.2Term Depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 investigate whether depressive symptoms improve in patients with type 2 diabetes
    E.2.2Secondary objectives of the trial
    To investigate whether blood sugar control and reduce systemic inflammation are reduced in patients with type 2 diabetes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A diagnosis of type 2 diabetes according to GP records or clinical guidelines for minimum 6 months
    2. Aged 18-75
    3. Poor glycaemic control defined as HbA1c 53-86 mmol/mol
    4. Already prescribed a first-line anti-diabetes agent (metformin or sulphonylurea) for at least 3 months
    5. Current PHQ-9 score ≥10
    6. Fluent in conversational English
    7. Able to sign informed consent form
    8. Use of contraception if female and of childbearing age. Female participants will require a negative serum pregnancy test before starting the study and will also need to agree to use an acceptable form of contraception throughout the intervention period, e.g. oral contraceptive pill, long-acting reversible contraceptive.

    E.4Principal exclusion criteria
    1. Advanced diabetes complications (registered blind, on dialysis, previous above-knee amputation) or treatment with insulin
    2. Pregnancy (tested with serum pregnancy test), planning pregnancy or lactating
    3. Severe mental disorders (psychosis, dementia, learning disability, alcohol/substance dependence, active suicidal ideation)
    4. Non diabetes-related inflammatory condition or history of pancreatitis
    5. Estimated Glomerular Filtration Rate <50ml/minute
    6. Morbid obesity (body mass index >40kg/m2)
    7. HbA1c >86 mmol/mol
    8. Currently prescribed an incretin-based therapy (dipeptidyl peptidase-IV inhibitor or GLP-1 receptor agonist)
    9. Currently prescribed an anti-depressant tablet or in receipt of psychological therapy for depression
    E.5 End points
    E.5.1Primary end point(s)
    Primary: change in depressive symptoms after 12 weeks as measured by the Patient Health Questionnaire-9 (PHQ-9) and Quick Inventory of Depressive Symptomatology (QIDS-SR-16).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Change in depressive symptoms after 4- and 8 weeks (mid-treatment) and 24 weeks (post-treatment) as measured by Patient Health Questionnaire-9 (PHQ-9) and Quick Inventory of Depressive Symptomatology (QIDS-SR-16).
    -Change in glycaemic control (fasting glucose, insulin resistance [homeostasis model assessment]), and inflammatory markers (interleukin-4 [IL-4], IL-6, IL-10, C-reactive protein, tumour necrosis factor-α, IL-1β, IL-1RA, vascular endothelial growth factor, monocyte chemotactic protein-1, white cell count and fasting triglycerides) after 4-, 8- and 12 weeks.
    -Change in HbA1c from baseline to 12 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4-, 8-, 12-, and 24 weeks after commencement of treatment
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The end of the trial will be defined as the date when all participants have made their final visits, the data entered in to the database and all queries resolved and the database locked.
    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 months9
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state44
    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)
    Participants will be offered detailed advice on how to access standard therapy for both their depression and their diabetes. They will be advised on accessing both antidepressant treatments and psychotherapeutic interventions.
    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 NIHR CRN: South London
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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