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    Summary
    EudraCT Number:2015-003672-76
    Sponsor's Protocol Code Number:Samba-03
    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:2018-09-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-003672-76
    A.3Full title of the trial
    A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects with Type 1 Diabetes Mellitus (T1DM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Dose Response of Dance 501 in Subjects with Type 1 Diabetes Mellitus (T1DM)
    A.4.1Sponsor's protocol code numberSamba-03
    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 SponsorDance Biopharm 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 supportDance Biopharm Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDance Biopharm, Inc
    B.5.2Functional name of contact pointDr. Lisa Porter
    B.5.3 Address:
    B.5.3.1Street AddressMint Plaza Ste. 804
    B.5.3.2Town/ citySan Francisco
    B.5.3.3Post codeCA 94103
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18583446515
    B.5.5Fax number+14155205249
    B.5.6E-maillporter@dancebiopharm.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 nameDance 501 Human Insulin Inhalation Solution
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number840
    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.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 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 nameDance 501 Human Insulin Inhalation Solution
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number280
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Humalog
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.9.4EV Substance CodeSUB08198MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    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 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 Mellitus
    E.1.1.1Medical condition in easily understood language
    Type 1 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 PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 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
    • Assessment of the linearity of the dose-response and dose-exposure relationship (based on AUCINS,0-10h, CMAX,INS, AUCGIR,0-10h, and GIRMAX ) of Dance 501 Human Insulin Inhalation Solution (INH) administered with the Dance 501 Inhaler
    E.2.2Secondary objectives of the trial
    • Assessment of the PK and PD responses at three doses of Dance 501 Human Insulin
    Inhalation Solution administered with the Dance 501 Inhaler
    • Assessment of the relative efficiency of Dance 501 Human Insulin Inhalation Solution
    administered with the Dance 501 Inhaler compared to s.c. insulin lispro
    • Safety and tolerability of Dance 501 Human Insulin Inhalation Solution administered with the Dance 501 Inhaler
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female subjects 18 to 55 years of age, inclusive
    • Diagnosed with T1DM
    • Body mass index (BMI) ≥ 18.5 and ≤ 30 kg/m2
    • HbA1c ≤ 9.0 % inclusive
    • Fasting C-peptide ≤ 0.30 nmol/L
    • Treated with 2 or more daily injections of insulin or continuous s.c. insulin infusion for at least 6 months prior to screening
    • Current total daily insulin treatment < 1.2 U/kg/day
    • Non-smoker for ≥ 5 years prior to screening. Negative screening urine cotinine test
    E.4Principal exclusion criteria
    • Any condition possibly affecting pulmonary drug absorption, in particular significant abnormalities in lung function testing, any active pulmonary disease, or treatment with bronchodilators
    • Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer
    • Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), or signs of acute illness, as judged by the Investigator
    • Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis
    • Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy
    • Recurrent severe hypoglycemia
    • Current treatment with drugs which may interfere with glucose metabolism
    E.5 End points
    E.5.1Primary end point(s)
    Primary Pharmacokinetic Endpoints:
    • AUCINS,0-10h, area under the human insulin and insulin lispro concentration-time curves from 0 to 10 hours (if AUCINS,0-10h cannot be reached, pre-defined restrictions will be followed (see section 13)
    • CMAX,INS, maximum observed concentration of human insulin and of insulin lispro

    Primary Pharmacodynamic Endpoints:
    1. AUCGIR,0-10h, area under GIR-time curve from t=0 to 10 hours
    2. GIRMAX, maximum observed GIR

    Safety endpoints:
    • Adverse events (including adverse device effects and hypoglycemic episodes)
    • Clinical laboratory measures
    • Physical examinations
    • Vital signs
    • Spirometry
    • Electrocardiogram (ECG)
    • Insulin antibodies
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Pharmacokinetic Endpoints:
    1. from t=0 to 10 hours
    2. maximum observed concentration

    Primary Pharmacodynamic Endpoints:
    1. from t=0 to 10 hours
    2. maximum observed GIR

    Safety endpoints:
    ongoing
    E.5.2Secondary end point(s)
    Secondary Pharmacokinetic Endpoints:
    • Area under the insulin (INS) curves (AUCINS) for different time-intervals: AUCINS,0-1h, AUCINS,0-2h, AUCINS,0-8h
    • Time to maximum insulin concentrations (tMAX,INS)
    • Relative efficiency (FREL, dose corrected ratio of AUCINS,ALL for INH and s.c. insulin)
    • Onset of appearance (time from trial product administration until the first time serum insulin concentration > LLOQ) (in case of different LLOQ values pre-defined restrictions will be followed (see section 13)
    • Mean residence time of insulin (MRTINS)

    Secondary Pharmacodynamic Endpoints:
    • Area under the glucose infusion rate (GIR) curves (AUCGIR) for different time-intervals: AUCGIR,0-1h, AUCGIR,0-2h, AUCGIR,0-8h
    • Time to maximum glucose infusion rate (tGIR,MAX)
    • Relative biopotency (GREL, dose corrected ratio of AUCGIR 0-10h for INH and s.c. Insulin)
    E.5.2.1Timepoint(s) of evaluation of this end point
    as given in section E.5.2
    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 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
    Dose response
    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 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 years
    E.8.9.1In the Member State concerned months5
    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: 24
    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 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 state24
    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)
    Subjects will resume their usual diabetes treatment after the end of the trial participation.
    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 Decision2018-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-13
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