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    Summary
    EudraCT Number:2012-003207-35
    Sponsor's Protocol Code Number:APCP-115,amendment
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-09
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-003207-35
    A.3Full title of the trial
    Effects of ARA 290, a non-hematopoietic erythropoietin analog, on glucose tolerance, insulin secretion, insulin sensitivity and long-term glucose control in individuals with prediabetes and/or drug-naive type 2 diabetes; a phase II study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety and ability of ARA 290 administered subcutaneously improving blood sugar control in people with prediabetes
    A.3.2Name or abbreviated title of the trial where available
    ARA290inT2D
    A.4.1Sponsor's protocol code numberAPCP-115,amendment
    A.5.4Other Identifiers
    Name:APCP-115,amendmentNumber:IMP supplier's protocol number
    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 SponsorKarolinska University Hospital Solna
    B.1.3.4CountrySweden
    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 supportAraim Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital Solna
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Endocrinology and Diabetes, Karolinska University Hospital, D2:04
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-17176
    B.5.3.4CountrySweden
    B.5.4Telephone number+46851776200
    B.5.5Fax number+46851773096
    B.5.6E-mailclaes.ostensson@karolinska.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 nameARA 290
    D.3.2Product code ARA 290
    D.3.4Pharmaceutical form Powder for 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 INNInnate repair activator peptide
    D.3.9.3Other descriptive nameARA 290
    D.3.9.4EV Substance CodeSUB31044
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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) No
    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 No
    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 typeSynthetic peptide
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    For the complementary visits; up to 12 Subjects with Prediabetes (impaired fasting glucose, impaired glucose tolerance) or diet-treated type 2 diabetes, will be chosen from the currently approved clinical protocol.
    E.1.1.1Medical condition in easily understood language
    Subjects with prediabetes identified by an oral glucose tolerance test, and/or type 2 diabetes controlled by diet alone
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10065542
    E.1.2Term Prediabetes
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the already approved study was to assess the effects of ARA 290, administered as a daily s.c. injection over 4 weeks, on oral glucose tolerance evaluated by OGTT in individuals with prediabetes (impaired fasting glucose, impaired glucose tolerance) and/or diet-treated type 2 diabetes.
    The objective of the 2 complementary visits is to observe the effect of one single dose of ARA 290 on the insulin and blood sugar levels when 300 mg/kg glucose is injected intavenously, compared to placebo.
    E.2.2Secondary objectives of the trial
    Approved study: To assess the effects of ARA 290 on:
    a) insulin sensitivity, evaluated by HOMA-IR modeling
    b) insulin secretion and long-term glucose-tolerance
    c) anti-inflammatory factors, cytokines etc., and
    d) other hormones, e.g. glucagon-like peptide-1 (GLP-1), glucagon.
    e) safety by registering reported AE and regular monitoring of vitale signs, hematology and Clinical chemistry
    For the complementary visits: No additional secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Informed consent obtained prior to any trial-related activities
    b. Meeting criteria for impaired fasting glucose (IFG), impaired glucose tolerance (IGT), IGF+IFG, or type 2 diabetes at the screening OGTT. IFG = fasting P-glucose 5.6-6.9 mmol/l; IGT = 2 hr P-glucose in OGTT 7.8-11.0 mmol/l; diabetes = fasting P-glucose ≥ 7.0 mmol/l and/or 2 hr P-glucose ≥ 11.1 mmol/l.
    c. Age 40-75 years, of both sexes, however women only above 50 year and in menopause.
    d. BMI (body mass index) ≤ 35 kg/m2.
    e. Fasting P-glucose ≤ 9 mmol/l.
    E.4Principal exclusion criteria
    a. Anticipated change in concomitant medication that may interfere with blood glucose homeostasis, such as systemic glucocorticoids, non-selective beta blockers and anabolic steroids.
    b. Anti-diabetic (anti-hyperglycemic) medication of any kind.
    c. Impaired renal function, defined as S-creatinine ≥ 125 umol/l for men and ≥ 115 umol/l for women.
    d. Impaired hepatic function defined as plasma alanin aminotransferase (P-ALT) ≥ three times the upper reference limit.
    e. Cardiac disease defined as unstable angina pectoris, or myocardial infarction within the last 6 months, or congestive heart failure NYHA class III or IV.
    f. Cerebral stroke within the last 6 months.
    g. Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg).
    h. Cancer, diagnosed and/or treated within the last 5 years.
    i. Females of childbearing potential.
    j. Known or suspected abuse of alcohol or narcotic drugs.
    k. Patients should not have received a vaccination or immunization within the month peior screening.
    l. The use of Anti-TNF therapy or other biological anti-inflammatory agents administered within 3 months to screening is not allowed.
    m. The use of erythropoiesis stimulating agents within the two months prior to screening or during the trial is not allowed.

    E.5 End points
    E.5.1Primary end point(s)
    To test whether there is a significant difference between persons receiving ARA290 vs.persons receiving placebo in glucose tolerance, evaluated by OGTT at baseline, and after 2 and 4 weeks.
    For the complementary visits: To test the effect of one single injection of ARA290 on insulin and blood sugar levels compared to one single injection of placebo.



    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre-treatment, at two weeks and at the end of four weeks of treatment.
    For the complementary visits: 2, 5, 7, 10, 20, 30, 60 and 120 minutes.
    E.5.2Secondary end point(s)
    Effects of ARA290 on:
    a. Insulin sensitivity, evaluated by HOMA-IR (13).
    b. Insulin secretion, examined both by measuring the early insulin response in OGTT and using HOMA-beta assessment.
    c. Long-term glucose Control, determined as glycosylated hemoglobin, HbA1c.
    d. Serum levels of inflammatory agents, e.g. cytokine levels.
    e. Serum levels of glucoregulatory hormones, such as glucagon-like peptide-1 (GLP-1), glucagon, and urinary levels of cortisol.
    f. Safety by registering reported adverse events, and by monitoring clinical chemistry parameters related to hematology, kidney function, liver function and lipid levels.

    For the complementary visits: No additional secondary endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pre-treatment, at 2 weeks and at the end of four weeks of treatment.
    N/A for the complementary visits
    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) 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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned 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: 12
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    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 Decision2013-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-02
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