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    Summary
    EudraCT Number:2011-002986-39
    Sponsor's Protocol Code Number:DXM/AMT
    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:2011-07-22
    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 number2011-002986-39
    A.3Full title of the trial
    A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Fourfold Cross-Over Study to Investigate the Glucose Lowering Effects of Dextromethorphan and Amantadine in Subjects with Type 2 Diabetes Mellitus (T2DM) after an Oral Glucose Tolerance Test
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Eine doppelblinde, placebokontrollierte, randomisierte Phase IIa Studie, mit Einzeldosierungen im vierfachen Cross-over-Design, zur Untersuchung der glukosesenkenden Wirkung von Dextromethorphan und Amantadin bei Probanden mit Diabetes mellitus Typ 2 (T2DM) nach einem oralen Glukosetoleranztest.
    A.4.1Sponsor's protocol code numberDXM/AMT
    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 SponsorProfil Institut für Stoffwechselforschung GmbH
    B.1.3.4CountryGermany
    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 supportProfil Institut für Stoffwechselforschung GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProfil Institut für Stoffwechselforschung GmbH
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressHellersbergstr. 9
    B.5.3.2Town/ cityNeuss
    B.5.3.3Post codeDE-41460
    B.5.3.4CountryGermany
    B.5.4Telephone number004921314018411
    B.5.5Fax number004921314018517
    B.5.6E-mailregulatory@profil.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 Yes
    D.2.1.1.1Trade name Hustenstiller-ratiopharm Dextromethorphan
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
    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.3.4Pharmaceutical form Capsule, hard
    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 INNDEXTROMETHORPHAN HYDROBROMIDE
    D.3.9.1CAS number 125-69-9
    D.3.9.4EV Substance CodeSUB01645MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Amantadin STADA 100 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderSTADApharm
    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.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 665-66-7
    D.3.9.3Other descriptive nameAMANTADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II 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
    The purpose of this trial is to demonstrate that dextromethorphan (DXM) and amantadine compared to placebo exert blood glucose (BG) lowering effects following an oral glucose tolerance test (OGTT) in male subjects with T2DM
    E.2.2Secondary objectives of the trial
    - To compare other pharmacodynamic (PD) properties (based on glucose, insulin, C-peptide and catecholamine measurements) of oral DXM and amantadine (termed: Investigational Medicinal Product – IMP) before and during an OGTT
    - For dextromethorphan: to assess whether a dose-dependency of PD exists
    -To compare the pharmacokinetic (PK) exposure to DXM and metabolites following an oral DXM dose for 5h post-dosing
    -To assess the PK/PD relationship (based on AUCDXM and AUCglucose)
    - To assess the safety after single oral dosing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male with T2DM on a stable regimen of metformin monotherapy, between 45 and 70 years of age, with a BMI between 25 and 35 kg/m2, HbA1c between 6.5 and 8% (extremes included).
    E.4Principal exclusion criteria
    - Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
    - Current or previous treatment with insulin therapy
    - Treatment with any hypoglycaemic medication other than metformin within the three months prior to screening
    - Any severe medical or surgical history of conditions likely to confound study assessments or study endpoints
    - Serious respiratory, serious and/or unstable coronary heart disease, congestive heart failure of New York Heart Association Class II or worse, second/third degree heart block, superior vena cava syndrome, uncontrolled hypertension, history of stroke (within the preceding 6 months) or serious peripheral vascular disease
    - History of arrhythmia that is symptomatic or requires treatment
    - Marked diabetic complications
    - Any respiratory disease leading to respiratory insufficiency and/or depression
    - Clinically significant vital signs or 12-lead ECG findings
    - Clinical or laboratory evidence of hepatic dysfunction or disease
    - Moderate or severe renal dysfunction defined as a calculated GFR <70 ml/min
    - Uncontrolled high blood pressure
    - History of relevant drug and/or food allergies or a history of severe anaphylactic reaction
    - Use of concomitant medication which would confound study conduct
    E.5 End points
    E.5.1Primary end point(s)
    The primary (PD) endpoint of the study is the area under the blood glucose (BG) concentration-time profile.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From 1-3 hours post-dose (i.e. from 0-2 hours after an OGTT)
    E.5.2Secondary end point(s)
    Secondary PD endpoints:
    1. Area under the blood glucose concentration-time profile
    2. Area under the blood glucose concentration-time profile
    3. Area under the blood glucose concentration-time profile
    4. maximum blood glucose excursion
    5. maximum blood glucose concentration
    6. time to maximum blood glucose concentration
    7. Area under the plasma insulin concentration-time profile
    8. Area under the plasma insulin concentration-time profile
    9. Area under the plasma insulin concentration-time profile
    10. Area under the plasma insulin concentration-time profile
    11. Maximum plasma insulin concentration
    12. Time to maximum plasma insulin concentration
    13. area under the catecholamine (adrenaline, noradrenaline) concentration-time profile
    14. catecholamine excursions

    Secondary PK endpoints:
    1. Area under the plasma DXM concentration-time profile
    2. Area under the plasma DXM concentration-time profile
    3. Area under the plasma HM concentration-time profile
    4. Area under the plasma HM concentration-time profile
    5. Area under the plasma DX concentration-time profile
    6. Area under the plasma DX concentration-time profile
    7. Area under the plasma MM concentration-time profile
    8. Area under the plasma MM concentration-time profile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary PD endpoints:
    1. from 0-1 hour post-dose
    2. from 1-5 hours post-dose
    3. from 1-1.5 hours post-dose
    4. after starting the OGTT
    5. after an OGTT
    6. after an OGTT
    7. from 0-1 hour post-dose
    8. from 1-1.5 hours post-dose
    9. from 1-5 hours post-dose
    10. from 1-3 hours post-dose
    11. after an OGTT
    12. after an OGTT
    13. from 1-5 hours post-dose
    14. from 0-1 hour post-dose

    Secondary PK endpoints:
    1. from 0-1 hour post-dose
    2. from 1-5 hours post-dose
    3. from 0-1 hour post-dose
    4. from 1-5 hours post-dose
    5. from 0-1 hour post-dose
    6. from 1-5 hours post-dose
    7. from 0-1 hour post-dose
    8. from 1-5 hours post-dose
    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 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
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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
    last patient/last visit
    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 months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female No
    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 state20
    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)
    expected normal treatment of that condition
    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 Decision2011-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-23
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