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    Summary
    EudraCT Number:2021-004226-30
    Sponsor's Protocol Code Number:ORA-D-013-2
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-01-27
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-004226-30
    A.3Full title of the trial
    A Double-Blinded, Placebo-controlled, Multi-center Randomized,
    Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801
    in Subjects with Type 2 Diabetes Mellitus with Inadequate
    Glycemic Control on Diet Control Alone or on Diet Control and
    Metformin Monotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Metformin Monotherapy
    A.4.1Sponsor's protocol code numberORA-D-013-2
    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 SponsorOramed Ltd.
    B.1.3.4CountryIsrael
    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 supportOramed Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrecision for Medicine
    B.5.2Functional name of contact pointBarbara Hevesi-Tóth
    B.5.3 Address:
    B.5.3.1Street AddressAlkotás u. 53. E. épület 2. em.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1123
    B.5.3.4CountryHungary
    B.5.4Telephone number+36703202870
    B.5.6E-mailbarbara.hevesi-toth@precisionformedicine.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.3.2Product code ORMD-0801
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNORMD-0801
    D.3.9.2Current sponsor codeORA-D-013-2
    D.3.9.3Other descriptive nameINSULIN HR1799
    D.3.9.4EV Substance CodeSUB129656
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    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 (T2DM)
    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 LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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
    To evaluate the efficacy of ORMD-0801 compared to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy over a 26-week treatment period.
    E.2.2Secondary objectives of the trial
    • To examine the efficacy of ORMD-0801 compared to placebo in maintaining glycemic control over a 52-week treatment period.
    • To compare the safety of ORMD-0801 treatment compared to placebo in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects aged, 18 to 75 years.
    2. Established diagnosis of T2DM prior to Screening AND an A1C ≥ 7.0% but ≤ 9.0% at Screening.
    3. Subjects should be on:
    a. Diet and exercise therapy and have never been treated with any oral or injectable glucose-lowering therapy, determined at Screening; OR
    b. Diet and exercise therapy with no oral or injectable glucose-lowering therapy for a period of at least 3 months prior to Screening; OR
    c. Diet and exercise therapy with a stable dose of metformin only (≥1500 mg or maximal tolerated dose) for a period of at least 3 months prior to Screening.
    4. Body mass index (BMI) of 25-40 kg/m2at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
    5. Renal function – eGFR ≥ 30 ml/min.
    6. Females of childbearing potential must:
    a. have a negative serum pregnancy test result at Screening.
    b. agree to avoid becoming pregnant while receiving IP for at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP.
    c. agree to use an acceptable method of contraception at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP. Acceptable methods of contraception are hormonal contraception (contraceptive pill or injection) PLUS an additional barrier method of contraception such as a diaphragm, condom, sponge, or spermicide.
    d. In the absence of hormonal contraception, double-barrier methods must be used which include a combination of any two of the following: diaphragm, condom, copper intrauterine device, sponge, or spermicide, and must be used for at least 30 days prior to administration of IP, during the entire study, and for 30 days following their last dose of IP.
    e. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and
    ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.
    f. Females who are not of childbearing potential are defined as:
    i. Postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); OR
    ii. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR
    iii. Have a congenital or acquired condition that prevents childbearing.
    E.4Principal exclusion criteria
    1. Type 1 diabetes.
    2. A history of diabetes mellitus with ketoacidosis or is assessed by the Investigator as possibly having type 1 diabetes mellitus confirmed by a C-peptide < 0.4 ng/mL (0.13 nmol/L) at Screening.
    3. Diabetes attributable to other secondary causes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
    4.Concomitant treatment involving insulin, and any other inhaled, oral or injectable antihyperglycemic agents including alpha glucosidase inhibitor, meglitinides, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione or GLP-1 agonists, and pramlintide except for metformin within 2
    months prior to Visit 1.
    5. A history of >2 episodes of severe hypoglycemia within 6 months prior to Screening.
    6. A history of hypoglycemic unawareness.
    7. A history of unstable angina or myocardial infarction within 6 months prior to Screening, New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure (CHF), valvular heart disease, ventricular cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, coronary angioplasty, stroke or transient ischemic attack (TIA) within 6 months prior to Screening.
    8. A history of uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg. A single repeat measurement will be permitted.
    9. Renal dysfunction: eGFR < 30 mL/min.
    10. A history of or active proliferative retinopathy requiring treatment.
    11. Psychiatric disorders that, per Investigator judgment, may have impact on the safety of the subject or interfere with subject’s participation or compliance in the study.
    12. Laboratory abnormalities at Screening including:
    a. C-peptide < 0.4 ng/mL.
    b. Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X the upper limit of normal; a single repeat test is allowable.
    c. Elevated liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) >3X the upper limit of normal; a single repeat test is allowable.
    d. Very elevated fasting triglyceride levels (>600 mg/dL); a single repeat test is allowable.
    e. Any relevant abnormality that would interfere with the efficacy or the safety assessments during study treatment administration.
    13. Positive history of active liver disease (other than non- alcoholic hepatic steatosis), primary biliary cirrhosis, or active symptomatic gallbladder disease.
    14. Positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus ribonucleic acid (RNA) [Subjects with a positive/reactive hepatitis B core antibody test and a negative/nonreactive HBsAg test with a negative/nonreactive hepatitis B core IgM antibody test and subjects with a positive/reactive hepatitis C antibody test and a negative/undetected HCV RNA test will be allowed to participate].
    15. Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma or carcinoma in situ of the cervix) within the past 5 years prior to baseline.
    16. Use of the following medications:
    a. History of use of any injectable or inhaled, basal, pre- mixed or prandial insulin (greater than 7 days) within 6 months prior to Screening.
    b. Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within 6 weeks prior to Screening.
    c. Requirements (in the last 12 months), or may require, systemic (oral, intravenous, intramuscular) glucocorticoid therapy for more than 2 weeks during the study period. Intra-articular and/or topical corticosteroids are not considered systemic.
    d. Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and immunosuppressive or immunomodulating agents. Inhaled nasal steroids are permissible.
    17. Known allergy to soy.
    18. Involvement in a weight loss program and is not in the maintenance phase, or subject has started weight loss medication (e.g., orlistat or liraglutide) within 3 months prior to Screening.
    19. Prior bariatric surgery.
    20. Subject is pregnant or breast-feeding.
    21. Subject is a user of recreational or illicit drugs or has had a recent history (within 1 year of Screening) of drug or alcohol abuse or dependence. (Note: Alcohol abuse includes heavy alcohol intake as defined by >3 drinks per day or >14 drinks per week or binge drinking) at Screening. Occasional intermittent use of cannabinoid products will be allowed provided that no cannabinoid products have been used during the 1 week prior to each visit.
    22. Any condition or other factor (at the Investigator’s discretion) that is deemed unsuitable for subject enrollment into the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 weeks (Visit 6)
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    1. Change from baseline (Visit 1) in fasting plasma glucose at 26 weeks (Visit 6).
    2. Incidence of A1C < 7% at 26 weeks (Visit 6).
    3. Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for treatment naïve subjects.

    Secondary Safety Endpoint:
    1. Safety assessed by adverse event reporting including adverse events of special interest such as hypoglycemia.

    Exploratory endpoints:
    • Changes from baseline (Visit 1) over time for A1C and FPG during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period.
    • Change from baseline (Visit 1) in CGM-parameters at weeks 26 and 52.
    o Mean Sensor Glucose, BG SD, BG CV, Time in range(TIR)—BG 70-180 mg/dL; BG 54-69 mg/dL, BG <54 mg/dL, BG 181-250 mg/dL, and BG >250 mg/dL.
    • Incidence of A1C < 8% at 26 weeks (Visit 6), and at 52 weeks (Visit 10).
    • Incidence of A1C < 7% at 52 weeks (Visit 10) without reported severe hypoglycemic events.
    • Incidence rate of subjects requiring glycemic rescue therapy and the time to rescue during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period.
    • Change in weight from baseline during the Double-Blind Treatment Period and the Double-Blind Treatment Extension
    Period.
    • Changes from baseline over time for C-peptide and HOMA during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary Endpoint: 26 weeks (Visit 6)

    Secondary Efficacy Endpoints: 26 weeks (Visit 6)

    Secondary Safety Endpoint: Based on adverse event reporting

    Exploratory endpoints:
    1. from baseline (Visit 1) during the Double- Blind Treatment Period and the Double-Blind Treatment Extension Period.
    2. from baseline (Visit 1) at weeks 26 and 52.
    3. at 26 weeks (Visit 6), and at 52 weeks (Visit 10).
    4. at 52 weeks (Visit 10)
    5. during the Double- Blind Treatment Period and the Double-Blind Treatment Extension Period.
    6. during the Double- Blind Treatment Period and the Double-Blind Treatment Extension Period.
    7. during the Double- Blind Treatment Period and the Double-Blind Treatment Extension Period.
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory
    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 No
    E.8.1.4Double blind Yes
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Israel
    Spain
    Germany
    Italy
    Hungary
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 383
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 450
    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 Decision2022-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-01-12
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