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    Summary
    EudraCT Number:2020-000444-58
    Sponsor's Protocol Code Number:CT041-ADO09
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-000444-58
    A.3Full title of the trial
    A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 prandial insulin in T1DM subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 prandial insulin in T1DM subjects
    A.4.1Sponsor's protocol code numberCT041-ADO09
    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 SponsorAdocia
    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 supportAdocia
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdocia
    B.5.2Functional name of contact pointDeputy General Manager
    B.5.3 Address:
    B.5.3.1Street Address115, Avenue Lacassagne
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69003
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472610610
    B.5.5Fax number+33472363967
    B.5.6E-mailo.soula@adocia.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 nameP037 (M1 Pram)
    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 INNPRAMLINTIDE
    D.3.9.1CAS number 151126-32-8
    D.3.9.4EV Substance CodeSUB09993MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInsulin M1
    D.3.9.3Other descriptive nameA21G human insulin
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 Humalog®
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameHumalog®
    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 LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.9.4EV Substance CodeSUB08198MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml 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 mellitus
    E.1.1.1Medical condition in easily understood language
    Type 1 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 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 compare the efficacy of prandial use of M1 Pram P037 with insulin lispro on body weight change after 16 weeks of optimised titration, in combination with a basal insulin.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and the safety of prandial use of M1 Pram P037 in comparison with insulin lispro after 16 weeks of treatment in combination with a basal insulin on:
    • Glycaemic control as assessed by continuous glucose monitoring (CGM)-derived
    parameters over the last 3 weeks of treatment: Time in range (TIR), time in tight range
    (TITR), time above range (TAR) and time below range (TBR) changes assessed from
    baseline to end of treatment and compared between each treatment, glycaemic
    variability
    • Safety, especially overall hypoglycaemia occurrence (number and duration), nocturnal
    hypoglycaemia (number and duration), and gastrointestinal events
    • Glycaemic control as assessed by change from baseline in HbA1c
    • Treatment satisfaction and well-being assessed by subjects
    • Change from baseline of total, prandial, and basal insulin doses after 16 weeks of
    treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated informed consent obtained before any trial-related activities. Trial
    related activities are any procedures that would not have been done during normal
    management of the subject.
    • Male or female subject with type 1 diabetes mellitus.
    • Age between 18 and 64 years, both inclusive.
    • Body Mass Index (BMI) between 25.0 and 35.0 kg/m^2, both inclusive.
    • HbA1c between 7.0 % and 9.5 %, both inclusive
    • Diabetes duration of at least 12 months.
    • Using a multiple dosing insulin therapy (MDI) with a basal insulin and a rapid-acting
    insulin at at least two meals per day.
    • Using any CGM or FGM for at least 1 month or willing to use CGM during the trial.
    E.4Principal exclusion criteria
    • Known or suspected hypersensitivity to IMPs or any of the excipients or to any
    component of the IMP formulation.
    • Type 2 diabetes mellitus.
    • Previous participation in this trial. Participation is defined as randomised.
    • Receipt of any medicinal product in clinical development within 3 months or at least 5
    half-lives of the related substances and their metabolites (whichever is longer) before
    randomisation in this trial.
    • History of multiple and/or severe allergies to drugs or foods or a history of severe
    anaphylactic reaction.
    • Any history or presence of cancer except basal cell skin cancer or squamous cell skin
    cancer as judged by the Investigator.
    • Clinically relevant comorbidity, capable of constituting a risk for the subject when
    participating in the trial or of interfering with the interpretation of data.
    • Clinically significant abnormal screening laboratory tests, as judged by the
    Investigator.
    • Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure <
    50 mmHg or > 89 mmHg (One repeat test (on a different day, if necessary) will be
    acceptable in case of suspected white-coat hypertension.
    • Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5
    minutes resting in supine position at screening, as judged by the Investigator.
    • Proliferative retinopathy or maculopathy as judged by the Investigator based on a
    recent (<1.5 years) ophthalmologic examination.
    • Severe neuropathy, in particular autonomic neuropathy, as judged by the
    Investigator.
    • More than one episode of severe hypoglycaemia with seizure, coma or requiring
    assistance of another person during the past 6 months.
    • Hypoglycaemic unawareness as judged by the Investigator.
    • Hospitalisation for diabetic ketoacidosis during the previous 6 months.
    • Presence of clinically significant gastrointestinal symptoms (e.g., nausea, vomiting,
    heartburn or diarrhea), as judged by the Investigator.
    • Confirmed diagnosis of gastroparesis or requiring the use of drugs that alter
    gastrointestinal motility.
    • Unusual meal habits and special diet requirements that could constitute a risk for the
    subject when participating in the trial or interfere with the interpretation of data.
    • Significant history of alcoholism or drug abuse as judged by the Investigator or
    consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for
    females) on average.
    • A positive result in the alcohol and/or urine drug screen at the screening visit.
    • Tested positive for Hepatitis Bs antigen.
    • Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not
    lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain
    reaction is negative).
    • Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.
    • Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists within 4 weeks
    prior to screening.
    • Use of systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra
    articular, or inhaled preparations) within 2 months prior to screening.
    • Use or planned use of drugs that promote weight loss (e.g. liraglutide, semaglutide,
    orlistat, lorcaserin, phentermine) within 2 months prior to screening.
    • Use or planned use of any other systemic medication that could interfere with the
    safety of the subjects or interpretation of the trial endpoints within 2 months prior to
    screening as judged by the Investigator.
    • Blood donation or blood loss of more than 500 mL within the last 3 months.
    • Mental incapacity, unwillingness or language barriers precluding adequate
    understanding or co-operation.
    • Committed to an institution by virtue of an order issued either by the judicial or the
    administrative authorities.
    • If female, pregnancy or breast-feeding.
    • Women of childbearing potential who are not using a highly effective contraceptive
    method.
    • The Investigator considers a subject as unsuitable for inclusion in the study for any
    other reason.
    E.5 End points
    E.5.1Primary end point(s)
    Body weight change from baseline to week 16 of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data base release
    E.5.2Secondary end point(s)
    Secondary endpoints:
    For secondary efficacy endpoints, change will be assessed from baseline to end of treatment (last three weeks of treatment for CGMs endpoints, carbohydrate consumption and for insulin doses) and compared between treatments. CGM metrics will be assessed overall and separately for night-time (0.00-05.59) and daytime (06.00-23.59). Treatment satisfaction and well-being will be analysed as change from baseline and comparison between groups at the end of treatment.

    Secondary Efficacy Endpoints:
    • Percentage body weight change from baseline to week 16 of treatment
    • Time and percentage of time in range [70-180] mg/dL change from baseline to week
    16 of treatment
    • Time and percentage of time in tight range [70-140] mg/dL change from baseline to
    week 16 of treatment
    • Time and percentage of time below range (TBR) defined as low [54-69 mg/dL] (TBR
    Level 1) and very low < 54 mg/dL (TBR Level 2) change from baseline to week 16 of
    treatment
    • Time and percentage of time above range (TAR) defined as elevated [181-250 mg/dL]
    (TAR Level 1) and very elevated > 250 mg/dL (TAR Level 2) change from baseline to
    week 16 of treatment
    • MeanG_24h: Average glucose over 24h change from baseline to week 16 of
    treatment
    • DistG_24h: Distance travelled over 24h change from baseline to week 16 of
    treatment
    • CVG_24h: coefficient of variation of glucose over 24h change from baseline to week
    16 of treatment
    • SDG_24h: SD of all glucose values over 24h change from baseline to week 16 of
    treatment
    • HbA1c change from baseline to week 16 of treatment
    • Treatment satisfaction, using a treatment satisfaction questionnaire (TSQ) and the
    WHO-5 well-being index
    • Change from baseline of total, prandial per meal, and basal insulin doses (per time
    interval and correction dose)

    Secondary Safety Endpoints:
    Safety endpoints will be evaluated from the first administration of the IMP to the follow-up visit of subjects.
    • Adverse events (AEs) Number and duration of AEs during the first, second, third and
    fourth month of the treatment period, and during the whole treatment period.
    • Hypoglycaemic episodes
    • Number and duration of gastrointestinal AEs, number of patients and treatment days
    with gastrointestinal AEs
    • Any reported adverse events
    • Injection site reactions
    • Abnormal findings or changes from baseline in clinical safety laboratory/physical
    examination/vital signs/ECG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data base release
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    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
    LSLV
    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 months10
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days13
    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: 80
    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 state80
    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)
    At the end of the trial subject will resume their usual prandial and basal insulin treatment according to the Investigator´s instructions.
    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 Decision2021-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-24
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