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    Summary
    EudraCT Number:2013-000225-30
    Sponsor's Protocol Code Number:DMA-Clin-199-2013-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000225-30
    A.3Full title of the trial
    A DOUBLE-BLINDED, PLACEBO-CONTROLLED, SINGLE DOSE AND MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PROOF OF CONCEPT OF DM-199 IN HEALTHY SUBJECTS AND PATIENTS WITH TYPE 2 DIABETES MELLITUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the safety, tolerability and the effect of DM-199 on the body, a new agent for the treatment of Diabetes Mellitus Type 2, after single- and multiple dosing in healthy volunteers and Diabetes Mellitus Type 2 patients.
    A.4.1Sponsor's protocol code numberDMA-Clin-199-2013-001
    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 SponsorDiaMedica USA Inc.
    B.1.3.4CountryUnited States
    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 supportDiaMedica USA Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPRA
    B.5.2Functional name of contact pointProject Associate/Suzanne Harms
    B.5.3 Address:
    B.5.3.1Street AddressStationsweg 163
    B.5.3.2Town/ cityZuidlaren
    B.5.3.3Post code9471 GP
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31504022 235
    B.5.5Fax number+31504022 223
    B.5.6E-mailHarmsSuzanne@praintl.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 nameDM-199
    D.3.2Product code DM-199
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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 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
    Diabetes Mellitus type 2
    E.1.1.1Medical condition in easily understood language
    Diabetes Mellitus type 2
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 evaluate the safety and tolerability of single and multiple subcutaneous doses of DM 199 in healthy subjects and type 2 diabetes mellitus patients

    to determine the plasma pharmacokinetic profile of DM-199 after administration of single and multiple doses of DM-199 in healthy subjects and type 2 diabetes mellitus patients
    E.2.2Secondary objectives of the trial
    to determine the effect of DM-199 on glucose homeostasis (via fasting glucose, fasting insuline and HbA1c levels), standardized meal tolerance test, C-peptide, fructosamine, GLP-1, glucagon, adiponectin, aldosterone, renin and lipids measurements, and homeostatic model assessment of insulin resistance/ beta cell function (HOMA) determination in type 2 diabetes mellitus patients

    to assess the formation of antibodies to DM-199 after administration of multiple doses of DM-199 in healthy subjects and type 2 diabetes mellitus patients

    to determine changes in immune cell populations by fluorescence-activated cell sorting analysis following multiple doses of DM-199 in healthy subjects and type 2 diabetes mellitus patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Status: Parts A and C: healthy subjects
    Parts B and D: type 2 diabetes mellitus patients
    2. Gender: Parts A, B, C and D: males and/or females;
    in Parts A, B and C, females may be of childbearing or non childbearing potential;
    in Part D, females must be of non-childbearing potential
    3. Age: Parts A and C: 18 - 65 years, inclusive
    Parts B and D: 18 - 75 years, inclusive
    4. BMI: Parts A and C: 18.0 - 30.0 kg/m2
    Parts B and D: 25.0 - 35.0 kg/m2 for Part B and 25.0 - 45.0 kg/m2 with a maximum body weight up to 165 kg for Part D; of eligible patients, those with a BMI ≥27 will preferably be included in order to match the demographics of the typical BMI observed in patients with well characterized type 2 diabetes mellitus in the United States of America
    5. For females of non-childbearing potential: females must be either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration of at least 12 months) and have a negative pregnancy test at screening and each admission
    6. For females of childbearing potential: females must be non-pregnant and non lactating, and have a negative serum pregnancy test at screening and each admission.
    7. For females of child-bearing potential: willingness to use adequate contraception from screening until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives combined with at least 1 of the following forms of contraception: an intrauterine device, a diaphragm or cervical cap, or a condom
    8. For males: willingness to use adequate contraception from entry in the clinical research center until 90 days after the follow-up visit
    9. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) and tobacco products from 48 hours prior to entry in the clinical research center until discharge each period
    10. Medical history without clinically significant abnormalities
    11. Parts A and C: Resting supine blood pressure of 140/90 mmHg or lower and higher than 90/50 mmHg, and showing no clinically relevant deviations as judged by the Principal Investigator
    12. Parts B and D: Resting supine blood pressure of 160/100 mmHg or lower and higher than 90/50 mmHg, and showing no clinically relevant deviations as judged by the Principal Investigator
    13. Computerised (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal Investigator
    14. All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Principal Investigator.
    15. Willing to sign the written Informed Consent Form (ICF

    Additional Inclusion Criteria Specific to Type 2 Diabetes Mellitus Patients (Part B and Part D)
    ++ Diagnosed with type 2 diabetes mellitus
    ++ Taking a stable dose of one or more oral anti-diabetic medications, such as metformin, sulphonylurea or any other orally administered glucose lowering medication (except for thiazolidinediones) for at least 3 months prior to screening
    ++ Receiving no other chronic medications, including dietary supplements, that alter blood glucose control. Non-systemic steroids are permitted
    ++ The use (before and in the same dose during the study) of antihypertensives, (except angiotensin-converting-enzyme (ACE) inhibitors) and drugs to treat dyslipidaemias (i.e. diuretics and statins)
    ++ Free of active infections requiring systemic treatments including chronic viral disease
    ++ Able and willing to wash-out all anti-diabetic medication for 14 days (Part B) or 28 days (Part D) prior to dosing
    ++ Part B: HbA1c (glycosylated hemoglobin) at screening between 6.5% and 9.0%, inclusive for patients using one oral anti-diabetic medication, and between 6.0% and 8.5%, inclusive for patients using two or more oral anti-diabetic medications/ Part D: HbA1c at screening between 6.5% and 10.0%, inclusive for patients using one oral anti-diabetic medication, and between 6.0% and 10.0%, inclusive for patients using two or more oral anti-diabetic medications
    ++ Part B: fasting blood glucose is within 7.5-13.5 mmol/L, inclusive at entry into the clinical research center (Day -1)/ Part D: fasting blood glucose is within 7.0-13.5 mmol/L, inclusive on Day -1
    ++ Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) liver enzymes up to 1.5 times upper limit of the normal (ULN)
    ++ Part D: adequate venous access for blood sampling.
    E.4Principal exclusion criteria
    1. Evidence of clinically relevant pathology
    2. Mental handicap
    3. History of relevant drug and/or food allergies
    4. Smoking more than 5 cigarettes, 1 cigar or 1 pipe daily
    5. Parts A to C: History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
    Part D: history of drug addiction (including soft drugs like cannabis products); history of alcohol abuse within the year prior to the start of the study
    6. Use of concomitant medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entry into the clinical research centre (after that time the use of a limited amount of acetaminophen is permitted after consultation with the Principal Investigator). Multivitamins and vitamin C are allowed up to 7 days before entry into the clinical research center. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John’s Wort extract) must have been stopped at least 14 days prior to entry into the clinical research center.
    7. Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months preceding the start of this study)
    8. Donation or blood loss of more than 50 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood (for men) / more than 1.0 litres of blood (for women) in the 10 months preceding the start of this study.
    9. Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
    10. Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
    11. Positive screen on HBsAg, anti-HCV or anti-HIV 1/2
    12. Illness within 7 days prior to (the first) drug administration
    13. Serum creatinine > upper limit of the normal (ULN) range

    Additional Exclusion Criteria Specific to Type 2 Diabetes Mellitus Patients (Part B and Part D)
    14. The use of insulin and thiazolidinediones for type 2 diabetes mellitus 3 months prior to screening is not allowed.
    15. History of diabetic ketoacidosis or hyperosmolar coma
    16. Advanced diabetic complications, including neuropathy, nephropathy, retinopathy or other symptoms
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    Parts A, B, C and D: adverse events, vital signs (including supine and standing systolic and diastolic blood pressure, pulse, body temperature, respiratory rate), 12-lead ECG, clinical laboratory (including clinical chemistry, hematology, coagulation and urinalysis) tests, local tolerability at injection site and physical examination
    :
    Part A: fasting and non-fasting serum glucose
    :
    Parts B, C and D: fasting glucose using the glucometer (or determined by the clinical laboratory for Part D patients only when they are in the clinic)
    :
    Parts C and D: anti-drug antibodies (ADA)

    PK : Parts A, B, C and D: plasma concentrations of DM-199 and PK parameters
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the different parts (A, B, C and D) of the study the primary end points will be scheduled at different timepoints according to Amended Protocol Version 4.0 dated 07NOV13 throughout the study.
    E.5.2Secondary end point(s)
    PD:
    Parts B and C: glucose (fasting and non-fasting), insulin, C-peptide, glucagon and GLP-1 (active and total); in Part B these will be measured as a response to a meal tolerance test (MTT)
    :
    Parts C and D: analysis of immune cell populations (lymphocytes, B lymphocytes, T (helper/cytotoxic) lymphocytes, monocytes and natural killer cells)
    :
    Part D: adiponectin, aldosterone, renin and lipid (total cholesterol, high density lipoprotein [HDL], low density lipoprotein [LDL], free fatty acids, triglycerides) concentrations

    POC:
    Part D: glucose (fasting and non-fasting), insulin, C-peptide, glucagon and GLP-1 (active and total) as a response to an MTT, fasting glucose using the glucometer (or determined by the clinical laboratory for Part D patients only when they are in the clinic), fasting insulin, fasting insuline, fructosamine and HbA1c
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the different parts (A, B, C and D) of the study the secondary end points will be scheduled at different timepoints according to Amended Protocol Version 4.0 dated 07NOV13 throughout the study.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Proof of Concept (POC).
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 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 trial7
    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 years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state96
    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 Decision2013-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-03
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