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    Summary
    EudraCT Number:2010-021373-37
    Sponsor's Protocol Code Number:HUBIN_L_05335
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-021373-37
    A.3Full title of the trial
    Evaluation of Insuman Implantable 400 IU/ml in patients with Type 1 diabetes treated with the Medtronic MiniMed Implantable Pump System using Insuplant 400 IU/mL
    A.4.1Sponsor's protocol code numberHUBIN_L_05335
    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 et 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Belgium
    B.5.2Functional name of contact pointBrigitte De Witte
    B.5.3 Address:
    B.5.3.1Street AddressAirport Plaza - Montreal Building, L. Da Vincilaan 19
    B.5.3.2Town/ cityDiegem
    B.5.3.3Post code1831
    B.5.3.4CountryBelgium
    B.5.4Telephone number+322710 54 00
    B.5.5Fax number+322710 56 99
    B.5.6E-mailcontac-us@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 No
    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 nameInsuman Implantable
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInsulin human
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeMedicinal product synthesised by recombinant DNA technology
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Insuplant 400 UI/ml
    D.2.1.1.2Name of the Marketing Authorisation holderPROSTRAKAN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameInsuplant
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNinsulin human
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 1 diabetes
    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
    The general objective of the study is to show the positive benefits /risks balance of using the recombinant insulin formulation (Insuman Implantable 400 UI/ml) compared to the semi-synthetic insulin (Insuplant 400 UI).
    Primary:
    • To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/mL with respect to the pump refill accuracy during a 4 refill cycle period (Comparative phase = 160+/- 20 days)

    • To assess efficacy measured by HbA1 change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/mL group after a 4 refill cycle period (comparative phase = 160+/- 20 days)
    E.2.2Secondary objectives of the trial
    Secondary:
    • To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuplant (insuplant non-comparative phase)
    • To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman (insuman non-comparative phase)
    • To evaluate daily insulin doses
    • To assess the Anti-Insulin Antibodies (AIA = ADA) levels during the comparative phase
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudies to be run in selected centers
    1) Pharmacokinetic parameters - breakfast profiles (3 centers): (Ctrough [predose insulin concentration], Cmax, Tmax, AUC0-4h free insulin) will be assessed in a subpopulation of 24 patients (12 patients per arm) at visit 2 and at the end of the comparative phase (V5).

    2) Evaluation of the quality of Insuman implantable and Insuplant (one study center-12 patients): In-use stability (i.e. assay of insulin and phenol, related substances, high molecular weight proteins, pH) of insulin remaining in the pump reservoir before each new refill procedure will be assessed for 12 patients (1 sample for each patient will be assessed at each refill (comparative phase). At each pump refill, the remaining insulin in the vials (not used) will also be kept for analysis.
    E.3Principal inclusion criteria
    Inclusion criteria for comparative phase
    • Patients already treated with Insuplant 400 IU/ml via a Medtronic MiniMed Implantable System 2007
    • HbA1c ≤ 9.0%
    • Patient showing a percentage of error at refill equal or below 20%
    • Patient undergoing a NaOH rinse procedure of at least 10 minutes period with or without flush
    Or
    Patient being re-implanted with a new pump (first fill with insulin)

    • Signed informed consent form prior to enrolment

    Inclusion criteria for Insuplant non-comparative phase

    • Patients already treated with Insuplant 400 IU/ml via a Medtronic MiniMed Implantable System 2007
    • Signed informed consent form prior to enrolment
    • Participation to the comparative phase
    or
    • Already treated with Insuplant
    • Beign implanted with Minimed Implantable Pump
    • Signed informed consent form prior to enrolment
    E.4Principal exclusion criteria
    Exclusion criteria for comparative phase
    • Pump life time > 6 years
    • Pump battery voltage < 2.6 volts
    • Pregnancy or childbearing potential without a medically approved form of birth control


    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints:
    • Refill accuracy between the 2 insulin groups after 4 refill cycles
    The refill accuracy is calculated as a difference expressed in percentage between the theoretical refill volume calculated by the PPC using programmed values and the actual refill volume used by weight measurements
    • HbA1c change from baseline in the 2 insulin groups after 4 refill cycles


    Safety endpoints:
    • Number of episodes of severe hypoglycaemia and non severe hypoglycaemia (<70 mg/dl) per patient (determined by SMBG or venous samples)
    • Number of DKA episodes (pH<7.25),
    • All adverse events,
    • Anti-insulin antibody (ADAs) levels assessment (at Baseline (visit 1) and at each subsequent refill visit up to visit 5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 4 refill cycles (approximately 6 months)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    in-use stability
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.4Double blind No
    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
    non-comparative study coupled with a parallel open label phase and followed by an extension phase
    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.8.3 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 EEA17
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 459
    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)
    The extension phase will last until the approval of the product
    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 Decision2011-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-01
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