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    Summary
    EudraCT Number:2020-003715-94
    Sponsor's Protocol Code Number:IDEAL
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-02
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-003715-94
    A.3Full title of the trial
    INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    De-intensification of intensive insulin therapy using the combination of long-acting insulin glargin and GLP-1 receptor agonist lixisenatide
    A.3.2Name or abbreviated title of the trial where available
    IDEAL
    A.4.1Sponsor's protocol code numberIDEAL
    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 SponsorInstitute for Clinical and Experimental Medicine
    B.1.3.4CountryCzech Republic
    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 supportSanofi
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute for Clinical and Experimental Medicine
    B.5.2Functional name of contact pointClinical Trial Infomation
    B.5.3 Address:
    B.5.3.1Street AddressVidenska 1958/9
    B.5.3.2Town/ cityPrague
    B.5.3.3Post code14021
    B.5.3.4CountryCzech Republic
    B.5.6E-mailmrzm@ikem.cz
    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 Suliqua
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 effect of the transition from multiple dose insulin regimen to the combination of insulin glargine and lixisenatide on metabolic control (HbA1c) in participants with T2DM during a 6-month intervention period.
    E.2.2Secondary objectives of the trial
    • to assess the safety of both treatment regimes in relation to incidence and event-rates of hypoglycemia using multiple hypoglycaemia definitions (cut-off, timing)
    • to assess patients’ compliance (adherence to treatment and the recommended SMBG pattern)
    • to assess other parameters of metabolic compensation including fasting plasma glucose and mean postprandial plasma glucose (calculated from 3 postprandial values taken after 3 main meals of the day), glycaemic variability of self-monitored fasting blood glucose, time in designated target range measured with CGM etc.
    • to assess the effect of both treatment regimens on body weight
    • to assess the effect of MDI to IGlarLixi transition on quality of life, treatment burden and fear of hypoglycemia
    • to assess the effect of both treatment regimens on selected exploratory laboratory parapeters including levels of adipokines, markers of hepatic steatosis and markers of low-grade inflammation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Type 2 diabetes mellitus
    • Intensive insulin therapy with at least 3 doses of prandial insulin and one dose of basal insulin/day for at least 3 months prior to screening
    • Total daily insulin dose ≤ 0.8 IU/kg
    • Fasting C peptide above the lower limit of the normal range
    • Treatment with metformin (unless intolerance to metformin use is present)
    • HbA1c ≤ 75 mmol/mol (9%)
    • HbA1c 76-86 mmol/mol (9.1-10%) in case of proven non-compliance with MDI regimen
    • Age 18-80 years
    E.4Principal exclusion criteria
    • Other diabetes types – type 1, secondary
    • Any contraindication to the use of GLP-1 receptor agonists
    • Daily dose of basal insulin >50 units/day
    • Acute myocardial infarction, unstable angina pectoris, stroke, pulmonary embolism 3 months prior to inclusion
    • Chronic heart failure NYHA III-IV
    • Chronic kidney disease CKD IIIb-IV, end-stage renal disease
    • Acute or chronic liver failure
    • Clinically significant gastroparesis
    • Active malignancy
    • Haemoglobin < 100 g/l
    • Pregnancy, breast-feeding, or in case of women with child-bearing potential willingness to be pregnant
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after initiation of treatment with IMP
    E.5.2Secondary end point(s)
    - proportion of patients with at least one episode of hypoglycemic event (24-hour, nocturnal (from bedtime to waking up), with 3.9 mmol/l and 3.0 mmol/l cut-offs)
    - proportion of patients with severe (third-party assistance) hypoglycemic event
    - hypoglycemia event-rate (24-hour, nocturnal (from bedtime to waking up), with 3.9 mmol/l and 3.0 mmol/l cut-offs)
    - change in percentage of time in hypoglycemia (3.9 mmol/l and 3.0 mmol/l cut-offs) range (by CGM) from BL to M6
    - number of missed injection doses detected by smart cap (vs the number of recommended injections relating to BB/Suliqua)
    - change in FPG from BL to M6
    - change in mean postprandial glucose (calculated as the mean of ppgs after 3 main meals of the daily BG profile measured at BL and M6)
    - change in glycemic variability measured as change in SD of fasting SMPG from BL to M6
    - Change in glycemic variability evaluated by CGM from BL to M6
    - change in percentage of time being spent within 4.0 – 10.0 mmol/l (70-180 mg/dl) range detected by CGM at BL vs at M6
    - change in body weight from BL to M6
    - change in QoL/treatment satisfaction from BL to M6
    - Adverse Events
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after initiation of treatment with IMP
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2020-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-27
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