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    Summary
    EudraCT Number:2020-004374-22
    Sponsor's Protocol Code Number:2020-09-HISTORI
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-03
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-004374-22
    A.3Full title of the trial
    HISTORI
    Home-based Intervention with Semaglutide Treatment Of
    Neuroleptica-Related Prediabetes
    The effect of Semaglutide on diabetes incidence and prevention in patients with in neuroleptica-related prediabetes.
    HISTORI
    Effekten af semaglutid (Ozempic) på HbA1c, metabolisk syndrom, livskvalitet og skizofrenisymptomer hos personer med skizofreni i antipsykotisk behandling: et randomiseret, placebokontrolleret studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of Semaglutide on diabetes incidence and prevention in patients with in neuroleptica-related prediabetes.
    Effekten af semaglutide på udvikling og forebyggelse af diabetes hos patienter med præ-diabetes grundet antipsykotisk behandling.
    A.3.2Name or abbreviated title of the trial where available
    HISTORI - Home-based Intervention with Semaglutide Treatment Of
    A.4.1Sponsor's protocol code number2020-09-HISTORI
    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 SponsorSteno Diabetes Center Odense
    B.1.3.4CountryDenmark
    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 supportThe Novo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNovo Nordisk APS
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSteno diabetes Center OUH
    B.5.2Functional name of contact pointAshok Ganeshalingam
    B.5.3 Address:
    B.5.3.1Street AddressKløvervænget 6, Entrance 93, Level 4
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004571700714
    B.5.6E-mailashok.ganeshalingam@rsyd.dk
    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 Ozempic
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Suspension for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOzempic
    D.3.9.1CAS number 910463-68-2
    D.3.9.3Other descriptive nameSEMAGLUTIDE
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1,34
    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 placeboConcentrate and solvent for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prediabetes and metabolic syndrome in SGA(second generation of antipshychotic treatment)-treated young adults with schizophrenia.
    Præ-diabetes og metabolisk syndrom, skizofrenisymptomer hos personer med skizofreni i antipsykotisk behandling.
    E.1.1.1Medical condition in easily understood language
    Condition that untreated will lead to type 2 diabetes and obesity related diseases including high blood pressure, elevated cholesterol levels in blood and cardiovascular disease.
    Forstadie til type 2 diabetes og metabolisk syndrom, som beskrives som fedme og fedme relaterede sygdomme som forhøjet blodtryk, kolesteroltal i blodet samt hjertekar sygdom.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10065542
    E.1.2Term Prediabetes
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10052066
    E.1.2Term Metabolic syndrome
    E.1.2System Organ Class 10020638 - Hyperglycaemic conditions NEC
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    GLP-1 analog is known for its beneficial effect on diabetes patients by reducing HbA1c, contributing weight loss, and preventing cardiovascular death.
    The hypothesis of this trial is that administration of Semaglutide 1.34 mg/ml (Ozempic®) for 30 weeks improves HbA1c (primary outcome) in SGA-treated young adults with schizophrenia suffering from prediabetes (HbA1c between 37 and 47 mmol/mol) and having a BMI ≥27 kg/m2, when compared against placebo. Additionally, that Semaglutide improves the following secondary endpoints: weight, quality of life measures, patient-related outcomes (PRO data) and the cardiometabolic risk factor profile.

    Primary Outcome: Changes in HbA1c after 30 weeks of treatment.
    I dette forskningsprojekt vil vi undersøge om semaglutid, som er et GLP-1 lignende lægemiddel, der skal gives en gang ugentligt, har en positiv virkning på patienter med skizofreni i antipsykotisk behandling. Vi vil se på om behandlingen kan medføre et fald i langtidsblodsukker, vægt og kolesteroltal. Herudover vil vi se på om det kan forbedre forsøgsdeltagernes skizofrenisymptomer og livskvalitet.
    E.2.2Secondary objectives of the trial
    BMI and waist circumference will be measured using standard techniques and equipment each month.
    Positive and Negative Symptom Scale (PANSS) is used for measuring symptom severity of patients with schizophrenia.
    Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
    PRO-data: Brief questionnaires (5-8 items each) concerning distress, food craving, physical activity and social function.
    Modifiable cardiovascular risk markers:
    PET/CT imaging: We want to perform a pilot study in a subsample, focusing on pre-symptomatic atherosclerosis assessed by positron emission tomography/computed tomography (PET/CT) using
    18F-sodium fluoride (NaF) as tracer.
    Screening for cardiovascular autonomic neuropathy (CAN).
    Markers of adipose tissue homeostasis.
    Markers of CVD. Insulin sensitivity regulates the insulin-like growth factor (IGF) system.
    Vi vil se på om behandlingen kan medføre et fald i vægt, BMI og kolesteroltal. Vi vil undersøge om der observeres faldende faste blodsukre og insulinniveaer.
    Herudover vil vi se på om det kan forbedre forsøgsdeltagernes skizofrenisymptomer og livskvalitet.
    Spørgeskemaer skal bidrage til at belyse forekomsten af skizofrenisymptomer, appetitregulering og selvoplevet livskvalitet.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    •Diagnosed with schizophrenia spectrum disorder (ICD10 codes DF20, DF21 or DF25)
    •Age between 18 and 60 years (both included)
    •Treated by one of the OPUS teams in the Region of Southern Denmark or Zealand
    •Stable antipsychotic SGA treatment for at least 6 months
    •Stable co-medication for at least 1 month
    •HbA1c between 39-47 mmol/mol (both included). Two measurements with ≥3 month interval are required to confirm prediabetes. The first measurement is identified from patient journals, the second prior to enrolment
    •BMI ≥27 kg/m2. Two weights with ≥3 month interval are required to confirm obesity
    •Capable of providing informed oral and written consent
    E.4Principal exclusion criteria
    Exclusion criteria
    •Diagnosis of diabetes (T1D or T2D) or a HbA1c >47 mmol/mol
    •Active malignant disease within the last 5 years
    •Pregnancy or breast feeding
    •Alcoholism (>21 / 14 units of alcohol for men / women, respectively) or severe substance abuse
    •Unwillingness to allow home visits by a study nurse
    •Significant somatic disease: 1) end-stage renal failure (eGFR <15 ml/min); 2) elevated liver function tests (liver transaminases >2 times upper normal limit); 3) history of acute or chronic pancreatitis; 4) heart failure (NYHA class IV) or unstable angina pectoris or myocardial infarction with the last 6 months; 5) uncontrolled hypertension (systolic blood pressure >180 mm Hg, diastolic blood pressure >100 mm Hg)
    •Previous treatment with study drug
    •Participation in other drug trials
    •Circumstances that the investigator believes will interfere with the trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point for the study will be changes in HbA1c. Changes in HbA1c will be evaluated after three months and after 6 months. A mixed effects linear regression analysis is used to compare changes in glucose tolerance, HbA1c, from baseline to six months’ follow-up between the intervention and the placebo groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Changes in HbA1c will be evaluable after three months and after 6 months
    E.5.2Secondary end point(s)
    Secondary endpoints:
    After 30 weeks of treatment.
    a)Metabolic measures: BMI, blood pressure, triglyceride, cholesterol (HDL and LDL) and waist circumference and HOMA-estimates based on fasting insulin and plasma glucose.
    b)Quality of life measures, using standardized questionnaires such as Impact of Weight on Quality of Life-Lite questionnaire (IWQOL-Lite).
    c)Psychotic symptoms and SGA adherence measures, using the Positive and Negative Syndrome Scale (PANSS) and measurement of adherence to SGA by the Antipsychotic Medication Beliefs and Attitudes Scale (AMBAS)
    d)PRO-data, using questionnaire-based assessment of distress (Kessler's 10-item psychological distress scale, food craving (Yale Food Addiction Scale (YFAS)), physical activity, the Simple Physical Activity Questionnaire (SIMPAQ) and overall function, Work and Social Adjustment Scale (WSAS).
    e)User perspectives, assessed through semi-structured interviews with 26 patients purposely sampled to cover the variability among subjects, focusing on 1) how SGA-treated patients experience the addition of a treatment requiring weekly injections; 2) what possible changes in everyday routines, mental and physical well-being do the patients experience during the intervention, and finally; 3) what opinions do the patients have concerning possible future pharmacological prevention coupled with treatment with anti-psychotic medication.

    Cardiovascular risk markers: pro-atherosclerotic changes as measured by NaF-PET/CT, cardiovascular autonomic neuropathy (CAN), and circulating levels of cardiovascular biomarkers.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints:
    After 30 weeks of treatment.
    a) Metabolic measures: BMI, blood pressure. Every 4th. week.
    b) Beginning and end og trial: Triglyceride, cholesterol (HDL and LDL)and HOMA-estimates based on fasting insulin and plasma glucose, cardiovascular risk markers.
    c) Every 4.th week: Quality of life measures.
    d) Pre study, at week 18 and end of study: PANNS and AMBAS
    e) Every 4.th week.: PRO-data, using YFAS, SIMPAQ and WSAS.
    f) Every 4: User perspectives.
    g) Prestudy, at week 18 and end of study: CAN Assesment
    h)Prestudy and end of study: NAF PET CT scan, 20 participant from placebo vs. 20 participants from trial drug.
    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 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) 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 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 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 months30
    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: 154
    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 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 2020-11-03. 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 state154
    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 concerning the trial drug. Patient will continue treatment for schizophrenia in the respective psychiatry department.
    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 Decision2020-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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