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    Summary
    EudraCT Number:2018-002191-41
    Sponsor's Protocol Code Number:AIDIT
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-07-03
    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 number2018-002191-41
    A.3Full title of the trial
    Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of type 1 diabetes with antibiotics, insulin, and dietary advice
    A.3.2Name or abbreviated title of the trial where available
    AIDIT
    A.4.1Sponsor's protocol code numberAIDIT
    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 SponsorUppsala University
    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 supportUppsala University
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportGothenburg University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUppsala University
    B.5.2Functional name of contact pointOlle Korsgren
    B.5.3 Address:
    B.5.3.1Street AddressThe Rudbeck Laboratory
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75185
    B.5.3.4CountrySweden
    B.5.6E-mailolle.korsgren@igp.uu.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 Yes
    D.2.1.1.1Trade name Azithromycin Sandoz 250 mg och 500 mg filmdragerade tabletter
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz A/Z
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Insulin lispro Sanofi 100 enheter/ml injektionsvätska, lösning i cylinderampull
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes
    E.1.1.1Medical condition in easily understood language
    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
    Overall Study Objective: Describe the influence of the Azithromycin Insulin Diet intervention trial (AIDIT) protocol consisting of long-term Azithromycin treatment combined with insulin-induced beta-cell rest and nutritional intervention on beta cell preservation in children newly diagnosed with Type 1 Diabetes.

    Primary objective: To compare the AIDIT protocol with treatment as usual at 12 months after diagnosis with respect to residual insulin secretion measured by mixed meal tolerance test (MMTT) stimulated C-peptide.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    To compare the two treatment regimens with respect to a number of defined variables, listed in the study protocol section 2.5.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Clinically diagnosed Type 1 Diabetes. First injection of insulin maximum ten days prior to inclusion.

    2. Must be willing and capable of taking the study drugs, perform tests and follow up as described as judged by the investigator.

    3. Signed informed consent and expected cooperation of the patients for the treatment and follow up.

    4. Aged 6.00 -15.99 years at inclusion.

    E.4Principal exclusion criteria
    1. Other diabetes diagnosis than Type 1 diabetes as judged by the investigator
    2. Severe ketoacidosis (DKA) with lowest pH <7.1 within 36 hours from diagnosis.
    3. Treatment with any oral or injected anti-diabetic medications other than insulin
    4. Significantly abnormal haematology results at screening.
    5. Participation in other clinical trials with a new chemical entity within the previous 3 months.
    6. Obesity at diagnosis (Iso-BMI ≥ 30 kg/m2 according to http://www.rikshandboken-bhv.se).
    7. Other autoimmune disease present at inclusion that in the opinion of the investigator would interfere with the study protocol.
    8. Celiac disease present at diagnosis.
    9. Treatment with medication known to affect glucohomeostasis, i.e. glucocorticoids (inhaled, nasal or skin topic will be accepted), statins, ACE inhibitors.
    10. Pregnancy or lactation
    11. Known gastro-intestinal malabsorption disorders
    12. Abnormalities in ECG or known cardiac disease
    13. Known hearing defects
    14. Known hypersensitivity to penicillin
    15. Inability or unwillingness to comply with the provisions of this protocol
    16. Presence of serious disease or condition in patient or family, which in the opinion of the investigator makes the patient non-eligible for the study.
    E.5 End points
    E.5.1Primary end point(s)
    Residual insulin secretion measured by mixed meal tolerance test (MMTT) stimulated C-peptide two-hour under the curve profile measured one year after study inclusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after inclusion.
    E.5.2Secondary end point(s)
    1. Proportion of subjects with time in target 3.9-7.8 mmol/L ≥ 60% and with a glycaemic variability expressed as standard deviation < 2 mmol/L according to continuous glucose monitoring during two weeks in the 12th month after initiation of the study treatment.
    2. Time in target (3.9-7.8 mmol/L) during 30 days in the 12th month after initiation of the study treatment.
    3. Time in range (3.9-10 mmol/L) during 30 days in the 12th month after initiation of the study treatment.
    4. Mean daily insulin dosage per kilo bodyweight during 30 days in the 12th month after initiation of the study treatment..
    5. HbA1c at 12 months after study initiation
    6. Number of severe hypoglycaemic events (hypoglycaemia level 3) during the study year.
    7. Time in hypoglycaemic range level 1 and 2 (<3.9 mmol/l and <3.0 mmol/l) respectively in CGM registrations during 30 days in the 12th month after initiation of the study treatment.
    8. Insulin-dose-adjusted HbA1c (IDAA1c) 12 months after study initiation
    9. Pro-insulin/c-peptide ratio in serum 12 months after study initiation
    10. Inflammation in the pancreas measured by contrast enhanced MRI at 12 months after initiation of the study
    11. Health related Quality of Life; Varni PedsQL, Generic and Diabetes specific questionnaire, by child and proxy (parents or other caregivers) at study start and 12 months after study initiation.
    12. Questionnaire on gastrointestinal symptoms: ”The gastrointestinal symptom rating scale” (GSRS) at study start and 12 months after study initiation .
    13. Average time spent eating at meals during four days in the 12th month after initiation of the study treatment.
    14. Intake of saturated fat (E% and if the child reaches Nordic Nutritional Recommendations, NNR) during four days in the 12th month after initiation of the study treatment.
    15. Intake of fruit and vegetables (g/day and if the child reaches NNR) during four days in the 12th month after initiation of the study treatment.
    16. Intake of macronutrients (E% and g/day) during four days in the 12th month after initiation of the study treatment.
    17. Intake of fibre (g/day and if the child reaches NNR) during four days in the 12th month after initiation of the study treatment.
    18. Objectively measured physical activity during one week in the 6th and in the 12th month after initiation of the study treatment.
    19. The oral microbiome at 12 months after study initiation.
    20. Change in stimulated c-peptide two-hour under the curve profile from 6 weeks to 12 months after initiation of study treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after inclusion.
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Treatment as usual
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    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 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-07-03. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors; Female and male patients between the ages of 6.00 and 15.99 years will be recruited. Written informed consent will be obtained from the patient and parents (or other legal caregivers) before inclusion in the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    Treatment as usual
    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 Decision2018-08-22
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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