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    Summary
    EudraCT Number:2021-005474-25
    Sponsor's Protocol Code Number:DC2021DESIGN1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-07-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-005474-25
    A.3Full title of the trial
    DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugliflozin in people with type 2 diabetes
    De effecten van diëtaire sodium inname op Ertugliflozine-geinduceerde veranderingen in GFR, oxygenatie, en systemische hemodynamiek: de DESIGN studie, een gerandomiseerde, placebo gecontroleerde, cross-over studie in mensen met type 2 Diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The combined effects of dietary salt intake and the antidiabetic therapeutic ertugliflozin on blood flow and oxygenation level of the kidney and the body in people with type 2 diabetes: the DESIGN study.
    De gecombineerde effecten van diëtaire zout inname en het diabetesmedicijn Ertugliflozine op bloeddoorstroming en zuurstofniveau van de nier en het lichaam: de DESIGN studie
    A.3.2Name or abbreviated title of the trial where available
    DESIGN
    A.4.1Sponsor's protocol code numberDC2021DESIGN1
    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 SponsorVUmc – Internal medicine / Diabetes Center
    B.1.3.4CountryNetherlands
    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 supportMerck Sharp & Dohme
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU medical center
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressBoelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.4CountryNetherlands
    B.5.6E-maild.vanraalte@amsterdamumc.nl
    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 Steglatro 15 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameertugliflozin
    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 INNErtugliflozin
    D.3.9.1CAS number 1210344-57-2
    D.3.9.2Current sponsor codeMK8835
    D.3.9.3Other descriptive nameSteglatro
    D.3.9.4EV Substance CodeSUB182716
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboFilm-coated tablet
    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
    Type 2 Diabetes Mellitus
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabetes
    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
    To investigate the modifying effects of WHO-recommended sodium intake (90 mmol per day) vs. high sodium intake (targeted at 250 mmol per day) on the effect of ertugliflozin 15 mg daily, versus placebo, on 24-hour blood pressure in overweight/obese adults with type 2 diabetes.
    Onderzoek naar het modificerende effect van WHO-aanbevolen natrium inname (90 mmol per dag) versus hoge natrium inname (250 mmol per dag) op het effect van Ertugliflozine 15mg 1dd1 versus placebo op 24uurs bloeddruk in volwassenen met overgewicht of obesitas en type 2 diabetes.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of ertugliflozin 15 mg daily, versus placebo, in overweight/obese adults with type 2 diabetes to reduce the hypertensive effects of a high-sodium diet (250 mmol per day) versus participant’s normal diet (170 mmol/per day).
    Onderzoek naar het effect van Ertugliflozine 15mg 1dd1 versus placebo op het verminderen van het hypertensieve effect van een hoog-zout dieet (250 mmol per dag) versus een normaal dieet (170 mmol per dag) in volwassen met overgewicht/obesitas en type 2 diabetes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults with previously diagnosed T2DM according to American Diabetes Association (ADA) criteria
    • • HbA1c 6.5-10%
    • • Age 35-80 years of age
    • • Overweight or obese with BMI: >25 kg/m2
    • • We will make every effort to enroll participants of all races/ethnicities.”
    • • Both sexes (females must be post-menopausal; no menses >1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as >31 U/L)
    • • Ability to provide signed and dated, written informed consent prior to any study procedures
    • • Estimated GFR 60-90 ml/min/1.73m2 by CKD-EPI matching the eGFR range of most participants in VERTIS-CV
    • • Sodium intake at baseline < 200 mmol/day
    • • UACR < 30 mg/mmol
    • • All participants need to be on a stable dose of RAS blocker
    • Volwassenen met gediagnosticeerde T2DM volgens de criteria van de American Diabetes Association (ADA)
    • HbA1c 6.5-10%
    • Leeftijd van 35-80 jaar
    • Overgewicht of obesitas met een BMI: >25 kg/m2
    • We zullen pogen participanten te includeren van alle rassen en etniciteiten.
    • Beide sekses (vrouwen moeten post-menopauzaal zijn; geen menses >1 jaar; in geval van twijfel zal Follicle-Stimulating Hormone (FSH) worden bepaald met een cut-off score van >31 U/L)
    • Mogelijkheid tot ondertekenen van een informed consent voorafgaand aan de studieprocedures
    • Estimated GFR van 60-90 ml/min/1.73m2 middels de CKD-EPI formule, overeenkomstig metd de eGFR range van de meeste participanten in de VERTIS-CV trial
    • Natrium inname op baseline < 200 mmol/dag
    • UACR < 30 mg/mmol
    • Alle participanten moeten op een stabiele dosis RAAS blokkade zijn
    E.4Principal exclusion criteria
    • History of unstable or rapidly progressing renal disease
    • Estimated GFR <60 mL/min/1.73m2 or eGFR > 90 mL/min/1.73m2 determined by CKD-EPI
    • UACR > 30 mg/mmol
    • Current/chronic use of the following medication: SGLT2 inhibitors, TZD, GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study.
    • Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, headache or back ache). However, no such drug can be taken within a timeframe of 2 weeks prior to renal testing • History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
    • Current urinary tract infection and active nephritis
    • Recent (<6 months) history of cardiovascular disease, including: Acute coronary syndrome, Chronic heart failure (New York Heart Association grade II-IV), Stroke or transient ischemic neurologic disorder
    • Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
    • History of or actual malignancy (except basal cell carcinoma)
    • History of or actual severe mental disease
    • Substance abuse (alcohol: defined as >4 units/day)
    • Allergy to any of the agents used in the study
    • Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study
    • Inability to understand the study protocol or give informed consent
    • Voorgeschiedenis van onstabiele of snel vorderende nierziektr
    • Estimated GFR <60 mL/min/1.73m2 of eGFR > 90 mL/min/1.73m2 volgens CKD-EPI
    • UACR > 30 mg/mmol
    • Huidig/chronisch gebruik van de volgende medicamenten: SGLT2 remmers, TZD, GLP-1RA, glucocorticoiden, immuunsuppressiva, antimicrobiele middelen, chemotherapeutica, antipsychotica, tricyclische antidepressiva (TCAs) en monoamine oxidase inhibitors (MAOIs). Mensen die gebruik maken van diuretica zullen enkel geexcludeerd worden wanneer deze medicatie niet gestopt kan worden voor de duur van de studie.
    • Chronisch gebruik van non-steroidal anti-inflammatory drugs (NSAIDs) wordt niet toegestaan, behalve als incidentele medicatie (1-2 tabletten) voor niet chronische situaties (i.e. sport blessurs, hoofdpijn, rugpijn). Dergelijke medicatie mag niet worden gebruikt in de twee weken voorafgaand aan de testdagen met renale testen.

    • Voorgeschiedenis van diabetische ketoacidose (DKA) waarvoor medische interventie is nodig geweest (e.g. bezoek aan de spoedeisende hulp of hospitalisatie) binnen 1 maand voorafgaande aan de screeningsvisite.
    • Huidige urineweginfectie of actieve nefritis.
    • Recente (<6 maanden) geschiedenis van cardiovasculaire ziekte, inclusief: Acuut coronair syndroom, chronische hartfalen (New York Heart Association graad II-IV), infract of TIA
    • Ernstige leverinsufficientie en/of significante abnormale leSevere hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
    • Voorgeschiedenis of huidige maligniteit (met uitzondering van basaal cel carcinoom)
    • Voorgeschiedenis of huidige zware mentale stoornis
    • Middelenmisbruik (voor alcohol gedefinieerd als >4 eenheden/dag)
    • Allergie voor testagenten gebruikt gedurende deze studie
    • Individuen die betrokken zijn bij de studie of een direct familielid zijn van mensen betrokken bij de studie (geliefde, ouder, kind, broer of zus, zowel biologisch als geadopteerd).
    • Onvermogen om het studieprotocol te begrijpen of informed consent te geven.
    E.5 End points
    E.5.1Primary end point(s)
    24-hr blood pressure
    24-uurs bloeddruk
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of each of the four study conditions. Every condition lasts 10 days.
    Aan het einde van elke studieconditie. In totaal zijn er vier studiecondities welke allen 10 dagen duren.
    E.5.2Secondary end point(s)
    • Sodium sensitivity
    • GFR by iohexol clearance
    • Hematocrit
    •Office blood pressure
    • Kidney oxygenation
    • Parameters of intrarenal hemodynamic function including ERPF by p-aminohippurate clearance and renal vasculature resistance
    • RAAS components
    •Body anthropometrics
    •Fasting plasma glucose
    •Albumin excretion rate (24 hour)
    •24-hr urinary glucose excretion
    •Urinary and plasma biomarkers
    • Natrium sensitiviteit
    • GFR door iohexol klaring
    • Hematocriet
    • Bloeddruk in de behandelkamer
    • Nier oxygenatie
    • Parameters van intrarenele hemodynamische functie inclusief ERPF gemeten door p-aminohippurate klaring en renale vasculaire weerstand
    • RAAS componenten
    • Antropometrie
    •Nuchtere bloed glucose
    •Albumine excretie (in 24 uur)
    •24-uurs urine glucose excretie
    •Urine en plasma biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of each of the four study conditions. Every condition lasts 10 days.
    Aan het einde van elke studieconditie. In totaal zijn er vier studiecondities welke allen 10 dagen duren.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Mechanistic research on the interaction between ertugloflozin and dietary salt intake on kdiney parameters and systemic parameters
    Een mechanistisch onderzoek naar de interactie tussen ertugliflozine en dietaire zoutinname op renale en systemische parameters
    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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    Verum versus placebo, en, hoge natrium inname versus lage natrium inname
    Verum versus placebo, and, high sodium intake versus low sodium intake
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 25
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 10
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 35
    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)
    After completion of the study the participants will return in care of their general practicionar.
    Na voltooing van de studie keren de deelnemers terug in de zorg van hun huisarts.
    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 Decision2023-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
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