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    Summary
    EudraCT Number:2021-005353-82
    Sponsor's Protocol Code Number:LPS17375
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-005353-82
    A.3Full title of the trial
    Prospective study to assess with Continuous Glucose Monitoring (CGM) the efficacy and safety of switching to insulin glargine 300 U/ml from insulin glargine 100 U/ml in Type 2 Diabetes (T2DM) patients with renal impairment
    Ensayo clínico, prospectivo de fase IV, de un solo brazo para evaluar con Monitorización Continua de Glucosa (MCG) la eficacia y seguridad del cambio a Glargina-300 desde Glargina-100 en pacientes con Diabetes Mellitus tipo 2 (DM2) e insuficiencia renal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Toujeo in Type 2 Diabetes patients with renal impairment
    Toujeo® en pacientes con DM2 e insuficiencia renal
    A.3.2Name or abbreviated title of the trial where available
    Renal-TIR
    Renal-TIR
    A.4.1Sponsor's protocol code numberLPS17375
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1266-7282
    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 SponsorSanofi-Aventis S.A
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-Aventis
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis, S.A
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.com
    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 Toujeo® 300 U/ml (solución inyectable)
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    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 nameInsulina glargina
    D.3.2Product code HOE901 - U300
    D.3.4Pharmaceutical form Solution 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 INNINSULIN GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901 - U300
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.8 Information on Placebo
    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
    Diabetes Mellitus tipo 2 (DM2)
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes Mellitus
    Diabetes Mellitus tipo 2 (DM2)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 evaluate the efficacy and safety of switching treatment with insulin glargine 100U/ml (Gla-100) to Insulin glargine 300U/ml (Gla-300) using CGM in patients with T2DM and renal impairment
    Evaluar la eficacia y seguridad del cambio de tratamiento con insulina glargina 100U/ml (Gla-100) a insulina glargina 300U/ml (Gla-300) mediante MCG (Monitorización continua de la glucosa) en pacientes con DM2 y alteración de la función renal
    E.2.2Secondary objectives of the trial
    • To determine glucose variability and glycemic control with CGM
    • To assess tolerability and safety profile
    • To assess patient satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQc) questionnaire
    - Determinar la variabilidad de la glucosa y el control glucémico con MCG.
    - Evaluar la tolerabilidad y el perfil de seguridad.
    - Evaluar la satisfacción del paciente mediante el cuestionario Diabetes Treatment Satisfaction Questionnaire (DTSQc)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosed with Type 2 Diabetes Mellitus ≥ 3 years prior to study enrolment
    Participants currently treated with Gla-100 for at least 4 months prior to enrollment with or without oral antidiabetics
    Estimated Glomerular filtration Rate (eGFR) between 30-60 ml/min
    HbA1c ≥ 7.5 y < 9% within 3 months prior to enrollment
    BMI between 25 and 40 kg/m2
    Ability and willingness to wear the Freestyle IQ Pro as required by the protocol
    Signed informed consent form
    - Diagnóstico de DM2 durante un periodo de tiempo ≥ 3 años con anterioridad al momento de inclusión en el estudio.
    - Pacientes en tratamiento con Gla-100 al menos 4 meses con anterioridad al momento de inclusión en el estudio, con o sin antidiabéticos orales
    - Pacientes con un valor de estimated Glomerular filtration Rate (eGFR) comprendido entre 30-60 ml/min.
    - Valores de HbA1c ≥ 7.5 y < 9% en los 3 meses previos a la inclusión.
    - Índice de Masa Corporal (IMC) entre 25 y 40 kg/m2.
    - Capacidad para llevar y hacer uso del sistema de MCG FreeStyle® libre Pro iQ.
    - Consentimiento informado (CI) firmado
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Pregnant or lactating women
    Participants who have been hospitalized for more than 7 days during screening period
    Presence of disease / treatment, which in the opinion of the investigator, affects the control of diabetes (e.g., chemotherapy, immunosuppressants, systemic corticosteroids)
    Participants enrolled during the study period in another clinical study
    Participants with basal-bolus regimen
    Los pacientes elegibles para este estudio no deben cumplir ninguno de los siguientes criterios:
    1. Mujeres embarazadas o en periodo de lactancia.
    2. Pacientes que hayan estado hospitalizados durante más de 7 días en el periodo de selección.
    3. Paciente que presente una patología o en tratamiento que, bajo criterio del investigador, afecte el control de la enfermedad diabética (por ejemplo, en tratamiento con quimioterapia, inmunosupresores o corticoesteroides sistémicos)
    4. Pacientes que se encuentren participando en otro ensayo clínico en el periodo de estudio.
    5. Pacientes con administración de insulina en régimen basal-bolo.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Month 5 in the percentage of Time in Range (TIR)
    Cambio desde el periodo basal hasta fin de estudio en el porcentaje del rango de glucosa objetivo, “Time In Range”, (TIR) (Tiempo en rango).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Month 5
    Desde el periodo basal hasta el mes 5
    E.5.2Secondary end point(s)
    - Mean glucose profile over 24 hours
    - % Coefficient of variation
    - % Time below target glucose Range (TBR)
    - % Time above target glucose Range (TAR)
    - Change from baseline to Month 5 in HbA1c
    - Change from baseline to Month 5 in Fasting Plasma Glucose (FPG)
    - Number of participants with at least one hypoglycemia event
    - Change from baseline to Month 5 in DTSQc
    - Number of participants with adverse events
    - Glucosa media perfiles de 24 horas
    - Coeficiente de Variación (CV) (%).
    - Porcentaje de lecturas por debajo del rango de glucosa objetivo, definido por sus siglas en inglés, “Time Below target glucose Range”, (TBR)*.
    - Porcentaje de lecturas por encima del rango de glucosa objetivo definido por sus siglas en inglés, “Time Above target glucose Range”, (TAR)*.
    - Cambio en los Niveles de HbA1c desde el periodo basal hasta el mes 5.
    - Cambio en glucosa plasmática en ayunas (FPG) desde el periodo basal hasta el mes 5.
    - Número de participantes con al menos un episodio de hipoglucemia
    - Cambio en DTSQc desde el periodo basal hasta el Mes 5.
    - Número de participantes con eventos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Month 5
    Desde el periodo basal hasta el mes 5.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned14
    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
    LPLV
    El periodo de fin de estudio se define como la fecha del último contacto con el último
    paciente del estudio que coincide con el último procedimiento programado mostrado en
    el Calendario de actividades (Véase Sección 1.3) y que tendrá lugar en el Q1 del 2023.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 2022-02-11. 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 state125
    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
    Ninguno
    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 Decision2022-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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