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    Summary
    EudraCT Number:2011-005011-93
    Sponsor's Protocol Code Number:2010DM03
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-005011-93
    A.3Full title of the trial
    Use of diazoxide in hypoglycaemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of diazoxide in people with type 1 diabetes in acute hypoglycaemia
    A.3.2Name or abbreviated title of the trial where available
    Use of diazoxide in acute hypoglycaemia
    A.4.1Sponsor's protocol code number2010DM03
    A.5.4Other Identifiers
    Name:NHS R&DNumber:2010DM03
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Dundee and NHS Tayside
    B.1.3.4CountryUnited Kingdom
    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 supportJuvenille Diabetes Research Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiomedical Research Institute
    B.5.2Functional name of contact pointDr Priya George
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Dundee, Clinical Research Centre level 7, Mail Box 11,
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01382 740507
    B.5.6E-mailp.george@dundee.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Tayside
    B.1.3.4CountryUnited Kingdom
    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 supportJuvenille Diabetes Research Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiomedical Research Institute
    B.5.2Functional name of contact pointPriya George
    B.5.3 Address:
    B.5.3.1Street AddressClinical Research Centre, Level 7, Ninewells Hospital
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01382740507
    B.5.6E-mailp.george@dundee.ac.uk
    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 Eudemine
    D.2.1.1.2Name of the Marketing Authorisation holderRPH Pharmaceuticals AB, Lagervagen 7, 136 50 Haninge, Sweden
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameDiazoxide
    D.3.4Pharmaceutical form Coated 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.3.8INN - Proposed INNEudamine
    D.3.9.1CAS number 364-98-7
    D.3.9.2Current sponsor code2010DM03
    D.3.9.3Other descriptive nameDiazoxide
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7mg/kg to 7mg/kg
    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 placeboCoated tablet
    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
    Hypoglycaemia
    E.1.1.1Medical condition in easily understood language
    Low blood sugars experienced by those with type 1 diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The body secretes hormones such as adrenaline as a response to low blood sugars. Patients who have had insulin-dependant diabetes for over 5 years rely heavily on adrenaline release, to produce symptoms, so that they can respond appropriately to low blood sugars. However, this response is blunted in those with type 1 diabetes.
    Our question is whether the degree of this response can be increased by use of diazoxide in the context of hypoglycaemia, so that patients with insulin-dependant diabetes become better aware of hypoglycaemia.
    E.2.2Secondary objectives of the trial
    Our study design enables us to bring down the blood sugar in a controlled fashion and maintain it at certain levels. We will be measuring hormones including adrenaline and testing cognitive function as well as assessing symptoms at each of these blood sugar levels. We want to see if diazoxide affects the threshold at which patients are able to detect hypoglycaemia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy adults (aged 18-55) with >5 years disease duration
    2. On intensive insulin therapy (CSII or multiple daily injections)
    3. HbA1C <8.0%
    4. Ability to give written informed consent to participate in the study
    5. BMI between 20-29
    E.4Principal exclusion criteria
    1. History of significant cardiac, hepatic, renal or neurological disease.
    2. Significant head injury, epilepsy or hypoglycaemia-induced seizures.
    3. Pregnancy.
    4. Participants who are currently breast feeding
    5. Participants on thiazide diuretics
    6. Participants on other potassium channel openers (nicorandil, minoxidil)
    7. Participants already on diazoxide or who have known documented allergy to diazoxide
    8. Participants on medications with vasodilatory properties such as methyldopa, reserpine, theophyllines and nitrites.
    9. Participants on hydantoins (fosphenytoin, phenytoin)
    10. Significant anaemia Hb<11.0 and Hct<33%.
    11. If they have donated blood in the last 30 days.
    12. All those who have participated in a CTIMP in the last 3 months
    E.5 End points
    E.5.1Primary end point(s)
    Magnitude of counter-regulatory epinephrine response to insulin induced hypoglycaemia. Epinephrine responses at 2.5mM glucose will be compared between diazoxide and placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adrenaline response will be measured when the patient reaches 2.5mmol/L blood glucose.
    This will be compared to baseline adrenaline measured at 4.0mmol/L blood glycose
    E.5.2Secondary end point(s)
    Thresholds for various parameters will be identified, as the blood sugar drops in phases. Adrenaline and other counter-regulatory hormone responses will be measured at 3.5,3.0,2.5.mmol/L and thresholds will be identified.
    Thresholds for symptoms of hypoglycaemia onset will be identified.
    Thresholds for cognitive dysfunction onset will be identified.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For each clamp experiment, measurements for each of the above parameters, will be taken at 4.0,3.5,3.0,2.5 mmol/L.
    These will be done for both the diazoxide arm as well as the placebo arm.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) 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 Yes
    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
    This will be the last visit of the last subject who has undergone the full trial. The total number of completed subjects should be 12.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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.1.3.1Number of subjects for this age range: 0
    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)
    The drug or placebo will be once off given before the start of the clamp study. This study does not look at long term effects of the drug.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-23
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