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    Summary
    EudraCT Number:2019-000781-38
    Sponsor's Protocol Code Number:sempa1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-14
    Trial results View 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 number2019-000781-38
    A.3Full title of the trial
    Effect of Empagliflozin and Semaglutide on Cardio-Renal Target Organ Damage in patients with type 2 diabetes – A randomized Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Empagliflozin and Semaglutide on the Cardiovascular system and Kidneys in patients with type 2 diabetes – A randomized Trial
    A.4.1Sponsor's protocol code numbersempa1
    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 SponsorAarhus University Hospital
    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 supportNovo Nordic Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAarhus University
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointEsben Laugesen
    B.5.3 Address:
    B.5.3.1Street AddressDiabetes og Hormonsygdomme, Aarhus Universitetshospital, Palle Juul-Jensens Boulevard 165
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.6E-mailauh.doh.sempa@rm.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
    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 INNSemaglutide
    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 milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.25 to 1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 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 Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 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 INNJardiance
    D.3.9.1CAS number 864070-44-0
    D.3.9.2Current sponsor codesempa1
    D.3.9.3Other descriptive nameEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Mellitus
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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
    The study has two co-primary aims:
    Aim 1:
    To test the hypothesis that treatment with empagliflozin, semaglutide or the combination vs. placebo improves arterial function in T2DM patients. Further, we aim to compare the different treatment modalities with each other (empagliflozin vs semaglutide, combination vs semaglutide, combination vs empagliflozin).
    The main outcome is change in arterial stiffness assessed as carotid-femoral PWV.

    Aim 2:
    To test the hypothesis that treatment with empagliflozin, semaglutide or the combination vs. placebo improves renal oxygenation in T2DM patients. Further, we aim to compare the different treatment modalities with each other (empagliflozin vs semaglutide, combination vs semaglutide, combination vs empagliflozin).
    The main outcome is change in renal oxygenation assesed by magnetic resonance imaging (MRI).
    E.2.2Secondary objectives of the trial
    Aim 3:
    To test the hypothesis that treatment with empagliflozin, semaglutide or the combination vs. placebo improves platelet function in T2DM patients. Further, we aim to compare the different treatment modalities with each other (empagliflozin vs semaglutide, combination vs semaglutide, combination vs empagliflozin).

    Aim 4:
    To test the hypothesis that treatment with empagliflozin, semaglutide or the combination vs. placebo improves glycemic control in T2DM patients. Further, we aim to compare the different treatment modalities with each other (empagliflozin vs semaglutide, combination vs semaglutide, combination vs empagliflozin).

    Aim 5:
    To test the effect of empagliflozin, semaglutide or the combination vs. Placebo on retinal metabolism and flow. Further, we aim to compare the different treatment modalities with each other (empagliflozin vs semaglutide, combination vs semaglutide, combination vs empagliflozin).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnose of type 2 diabetes.
    HbA1c level of 7% (53 mmol/mol) or more.
    Age of 50 years or more with established cardiovascular disease (prior myocardial infarction, prior stroke or prior transient ischemic attack, prior coronary, carotid or peripheral arterial revascularization, more than 50 % stenosis on angiography or imaging of coronary, carotid or lower extremities arteries, history of symptomatic coronary heart disease documented by e.g. positive exercise stress test or any cardiac imaging or unstable angina with electrocardiography (ECG) changes), or chronic heart failure (New York Heart Association class II or III).
    or
    Age of 60 years or more with at least one cardiovascular risk factor (persistent microalbuminuria (30-299 mg/g) or proteinuria, hypertension and left ventricular hypertrophy by electrogram or imaging, left ventricular systolic or diastolic dysfunction by imaging or ankle/brachial index less than 0.9).
    E.4Principal exclusion criteria
    Estimated glomerular filtration rate < 60 ml/min.
    Treatment with a SGLT2-inhibitor, GLP-1-receptor agonist or dipeptidyl-peptidase 4 inhibitor within 30 days before screening or insulin other than basal or premixed within 30 days before screening.
    A history of an acute coronary or cerebrovascular event within 90 days before randomization.
    Planned revascularization of a coronary, carotid, or peripheral artery.
    Inability to give informed consent.
    Active cancer diagnosis other than basal cell carcinoma.
    Indication of liver disease (serum ALAT, ASAT or alkaline phosphatase above 3 x upper limit).
    Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
    Treatment with systemic steroids at time of randomization.
    Change in dosage of thyroid hormones within 6 weeks prior to screening.
    Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake.
    Chronic or acute pancreatitis.
    Pregnancy or breastfeeding.
    Allergy to either empagliflozin or semaglutide or any of the excipients contained in the drugs.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in arterial stiffness assessed as carotid-femoral PWV and change in renal oxygenation assesed by magnetic resonance imaging (MRI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated at baseline, after 16 weeks of treatment and after 32 weeks of treatments.
    E.5.2Secondary end point(s)
    Secondary endpoints to Aim 1:
    Change in endothelial function, ambulatory PWV and central Blood Pressure indices and ambulatory Blood Pressure.

    Secondary endpoints to Aim 2:
    Change in glomerular filtration rate (GFR), renal plasma flow (RPF), corticomedullary sodium homeostasis and markers of the renin-angiotensin system. Change in urinary albumin excretion and urine-Prostaglandin E (PGE)

    Secondary endpoints to Aim 3:
    Change in platelet aggregation, Platelet count and turnover

    Secondary endpoints to Aim 4:
    Change in mean glucose level and glucose variability assessed by continuous glucose monitoring (CGM) and HbA1c. Change in Insulin sensitivity, beta-cell responsitivity and hepatic insulin extraction evaluated by the oral minimal model method using an oral glucose tolerance test with multiple bloodsampling. Change in Betahydroxybutyrat levels.


    Secondary endpoints to Aim 5:
    Change in retinal oxygenation, metabolism and flow assed by oximetry and retinal arterial and venolar vasomotion assessed by Retinal Vessel Analyzer (RVA). Change in retinal thickness assessed by Optical Coherence Tomography (OCT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated at baseline, after 16 weeks of treatment and after 32 weeks of treatments.
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Semaglutide treatment is open-label and empagliflozin is double-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 Yes
    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
    7 weeks after the last visit of the last subject.

    Semaglutide has a long half-life. We will collect information of adverse events and adverse reactions until 7 weeks after the last visit.
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state120
    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 Decision2019-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-04
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