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    Summary
    EudraCT Number:2015-001626-42
    Sponsor's Protocol Code Number:LPS14409
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-08
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-001626-42
    A.3Full title of the trial
    A 24-Week, Multicenter, Randomized, Open-Label, 2-Arm Parallel-group Study Evaluating the Efficacy and Safety of Patient- Versus Physician-managed Titration of Insulin Glargine U300 in Type 2 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Patient- Versus Physician-managed Titration of Insulin Glargine U300 in Type 2 Diabetes Mellitus patients
    A.4.1Sponsor's protocol code numberLPS14409
    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 recherche & développement
    B.1.3.4CountryFrance
    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 groupe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Sp. z o.o.
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street Addressul. Bonifraterska 17
    B.5.3.2Town/ cityWarszawa
    B.5.3.3Post code00-203
    B.5.3.4CountryPoland
    B.5.4Telephone number+482228 00 000
    B.5.6E-mailinformacja.medyczna@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
    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 nameInsulin glargine
    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
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    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 20.0
    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 demonstrate non-inferiority in terms of glycemic control, measured as change in glycated hemoglobin (HbA1c), of a patient- versus a physician-managed titration algorithm, for the treatment with HOE901-U300 (Insulin Glargine U300), in patients with inadequately controlled Type 2 Diabetes Mellitus (T2DM).
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy, safety, and quality of life of the two titration approaches in terms of:
    -Percentage of patients reaching fasting self-monitored plasma glucose (SMPG) target.
    -Hypoglycemic events
    -Change in HbA1c from baseline across subgroups of baseline HbA1c category (< 8%, ≥ 8 to <9%, ≥9 %).
    -Safety and tolerability.
    -Change in Patient-Reported Outcome (PRO) instruments (Diabetes Distress Scale and Diabetes Empowerment Scale).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with T2DM as defined by World Health Organization (WHO) diagnosed for at least 1 year at the time of the screening visit, treated with ≥1 non-insulin antihyperglycemic drug(s) with or without a basal insulin, for at least 6 months.
    -Signed informed consent
    E.4Principal exclusion criteria
    -Age <18 years old.
    -HbA1c at screening visit:
    -<7.0% or >10.0% for patients taking basal insulin.
    -<7.5% or >11.0% for insulin-naive patients.
    -Patient not willing to self-manage titration algorithm (including self-injection, SMPG).
    -Type 1 diabetes mellitus.
    -Insulin-pretreated patients not on a stable basal insulin regimen in the last 12 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection); the insulin dose should be stable (±20 %) for at least 8 weeks prior to screening visit.
    -Change in dose of existing, or initiation of new, non-insulin antidiabetic drugs in the last 12 weeks prior to screening visit.
    -Treatment with an insulin other than basal insulin: mixed insulin (premixes), rapid insulin, fast acting insulin analogues in the last 6 months before screening (use ≤10 days in relation to hospitalization or an acute illness is accepted).
    -Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening.
    -History of hypoglycemia unawareness.
    -Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any condition (including known substance or alcohol abuse, or psychiatric disorder) that in the opinion of the Investigator or any sub-Investigator would make implementation of the protocol or interpretation of the study results difficult or would preclude the safe participation of the subject in this protocol.
    -Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening visit.
    -Patients included (or planned to be included during study duration) in Toujeo Customized Patient Solution (CPS) program or any other patient support program (PSP).
    -Pregnant or breast-feeding women.
    -Women of childbearing potential not protected by highly effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
    -Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in HbA1c compared between the two titration modality arms (Patient- and Physician-managed titration)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 24
    E.5.2Secondary end point(s)
    1- Percentage of patients achieving targeted fasting SMPG (80-130 mg/dL[4.4 -7.2 mmol/L]) without experiencing severe and/or confirmed hypoglycemia<54 mg/dL (3.0 mmol/L)
    2- Percentage of patients experiencing at least one hypoglycemia
    3- Number of hypoglycemic events per patient-year during the study treatment period
    4- Percentage of patients reaching targeted fasting SMPG (80-130 mg/dL [4.4 -7.2 mmol/L])
    5- Time (weeks) to reach target fasting pre-breakfast SMPG
    6- Mean change in HbA1c
    7- Mean change in HbA1c across subgroups of baseline HbA1c category (< 8%, ≥ 8 to <9%, ≥9 %)
    8- Mean of 7-point SMPG profile
    9- Mean change by SMPG time point
    10- Number of patients with adverse events
    11- Mean change in FPG
    12- Mean change in HOE901-U300 dose
    13- Mean change in body weight
    14- Mean change on the Diabetes Distress Scale (DDS)
    15- Percentage of patients with high distress (average scores >3) at each occasion on the Diabetes Distress Scale (DDS)
    16- Mean change on the Diabetes Empowerment Scale (DES)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12 and Week 24
    1, 4, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

    Baseline to Week 24
    2, 3, 5
    Baseline to Week 12
    6


    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Patient-managed titration versus Physician-managed titration of Insulin Glargin in T2DM patients
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA89
    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
    Croatia
    Czech Republic
    Denmark
    Greece
    Poland
    Slovakia
    Slovenia
    Spain
    Switzerland
    United Kingdom
    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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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: 444
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 148
    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 state154
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 568
    F.4.2.2In the whole clinical trial 592
    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 Decision2016-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-02
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