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    Summary
    EudraCT Number:2016-004691-22
    Sponsor's Protocol Code Number:RCT-004
    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:2017-08-29
    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 number2016-004691-22
    A.3Full title of the trial
    A Randomised, Open, Parallel-group Phase III Biosimilarity Study to Assess the Long-term Safety, Focusing on Immunogenicity, of Rechon Insulin Human Soluble in Type 1 Diabetic Patients.
    Randomizowane, otwarte, prowadzone w grupach równoległych badanie biopodobieństwa fazy III oceniające bezpieczeństwo w długim okresie, ze szczególnym uwzględnieniem immunogenności, produktu Rechon Insulin Human Soluble u chorych na cukrzycę typu I
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Long-term Safety of Rechon Insulin Human Soluble in Type 1 Diabetic Patients.
    A.4.1Sponsor's protocol code numberRCT-004
    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 SponsorRechon Life Science AB
    B.1.3.4CountrySweden
    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 supportRechon Life Science AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRechon Life Science AB
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 60043
    B.5.3.2Town/ cityLimhamn
    B.5.3.3Post codeSE-216 10
    B.5.3.4CountrySweden
    B.5.6E-mailinfo@rechon.se
    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 nameInsulin Human Soluble
    D.3.4Pharmaceutical form Solution for injection
    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 HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor code570050
    D.3.9.3Other descriptive nameRecombinant human insulin
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 Humulin® Regular 100 IE/ml
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Sweden AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameHumulin Regular 100 IE/ml
    D.3.4Pharmaceutical form Solution for injection
    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 HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.3Other descriptive nameRecombinant human insulin
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 1 Diabetes
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes
    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 10012601
    E.1.2Term 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 asses the long-term safety of Rechon Human Insulin Soluble as compared to Humulin® Regular in terms of immunogenicity and insulin tolerance.
    E.2.2Secondary objectives of the trial
    To assess the long-term safety of Rechon Human Insulin Soluble as compared to Humulin® Regular in terms of general safety variables.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patients have to meet all of the following criteria to be eligible to enter the study:
    1) Willing and able to provide informed consent
    2) Male or female diagnosed with T1DM diagnosed since at least 2 years
    3) Ongoing daily treatment with insulin for at least 12 months
    4) Current treatment with insulin below or equal to 1.2 U/kg/day
    5) Age 18-75 (both inclusive) at the time of signing informed consent
    6) BMI 18.0-32.0 kg/m2 (both inclusive)
    7) HbA1c (glycosylated haemoglobin A1c) below or equal to 94 mmol/mol
    8) Women must be:
    • postmenopausal, defined as above 45 years of age with amenorrhea for at least 18 months, or above 45 years of age with amenorrhea for at least 6 months and less than 18 months and a known serum follicle stimulating hormone (FSH) level above 40 IU/L, or
    • surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal occlusion), or otherwise be incapable of pregnancy, or
    • heterosexually active and practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, or male partner sterilization, consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study, or
    • not heterosexually active. Note: patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study
    9) Women of childbearing potential (i.e., those patients who do not meet the postmenopausal definition above, regardless of age) must have a negative urine pregnancy test at baseline (Day 1) and at screening if required by local regulations (Note: a serum pregnancy test is acceptable in lieu of a urine pregnancy test if required by local regulations)
    E.4Principal exclusion criteria
    Exclusion RLS protocol version 6.0
    Patients meeting any of the following criteria will not be permitted to enter the study:
    1) Known allergies, hypersensitivity, or intolerance to the IMP or its excipients (see Section 9.1.2)
    2) Renal disease that require treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant. Note: patients with a history of treated childhood renal disease without sequelae may participate
    3) Myocardial infarction, unstable angina, revascularisation procedure, or cerebrovascular accident within 3 months before screening, or a planned revascularisation procedure, or history of New York Heart Association (NYHA) Class IV cardiac disease (The Criteria Committee of the New York Heart Association)
    4) Known history of hepatitis B surface antigen or hepatitis C antibody positive (unless known to be associated with documented persistently stable/normal range aspartate aminotransferase [AST] and alanine aminotransferase [ALT] levels), or other clinically active liver disease
    5) Female patients: pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
    6) History of malignancy within 5 years before screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence)
    7) History of human immunodeficiency virus (HIV) antibody positive
    8) History of one or more severe hypoglycaemic episodes within 6 months before screening Note: a severe hypoglycaemic episode is defined as an event that requires the help of another person. This refers to hypoglycaemic episodes which are correlated to the patients insulin sensitivitiy and not caused by incidents as for example medication error or acute in hospital treatment for other reasons.
    9) Investigator’s assessment that the patient’s life expectancy is less than 1 year, or any condition, for example patients with severe co- diseases, that in the opinion of the Investigator would make participation not in the best interest of the patient, would interfere with the patients ability to participate in all study visits and complete the whole study, or could prevent, limit, or confound the protocol-specified safety or efficacy assessments
    10) Major surgery (i.e. requiring general anaesthesia) within 3 months of the screening visit or any surgery planned during the patient’s expected participation in the study (except minor surgery, i.e. outpatient surgery under local anaesthesia)
    11) Any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or prevent the patient from meeting or performing study requirements
    12) Current use of a corticosteroid medication or immunosuppressive agents, or likely to require treatment with a corticosteroid medication (for longer than 2 weeks in duration) or an immunosuppressive agent. Note: patients using inhaled, intranasal, intra-articular, or topical corticosteroids, or corticosteroids in therapeutic replacement doses may participate
    13) Use of other antidiabetic therapy than insulin
    14) Received an active investigational drug (including vaccines) or used an investigational medical device within 3 months before Day 1/baseline
    15) Employees of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator
    16) More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients having binding antibodies against human insulin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Visit 2 (baseline) to Visit 5.
    E.5.2Secondary end point(s)
    • Change in levels of insulin binding antibodies
    • Change in neutralizing capacity of anti-insulin antibodies
    • Change in insulin dose
    • Change in HbA1c
    • Change in fasting blood glucose
    • Hypoglycaemic episodes, classified according to American Diabetes Association (ADA), during the period
    • Change in levels of total circulating IgE antibodies
    • Incidents of local or systemic hypersensitivity during the period
    • Change in safety laboratory parameters
    • Change in body weight
    • Change in vital signs
    • Change in physical status
    • Number and type of AEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints except Number and type of AEs: from Visit 2 (baseline) to Visit 5
    Number and type of AEs: from first dose of IMP to the completion of Visit 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 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) 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 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 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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 months3
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days12
    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: 281
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 94
    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 state375
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 375
    F.4.2.2In the whole clinical trial 375
    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)
    No specific plans
    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 Decision2017-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-17
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