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    Summary
    EudraCT Number:2015-005740-34
    Sponsor's Protocol Code Number:ESR-14-10698
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-29
    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 number2015-005740-34
    A.3Full title of the trial
    Effectiveness of Dapagliflozin + Saxagliptin to revert from a standard basalbolus
    insulin treatment (BBIT) regimen to a basal supported oral therapy
    (BOT) in patients with Type 2 Diabetes – a randomised double-blinded
    study – a randomised double-blinded study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of Dapagliflozin + Saxagliptin to revert from a standard basalbolus
    insulin treatment (BBIT) regimen to a basal supported oral therapy
    (BOT) in patients with Type 2 Diabetes – a randomised double-blinded
    study – a randomised double-blinded study
    A.3.2Name or abbreviated title of the trial where available
    Dapa-Saxa-BBIT
    A.4.1Sponsor's protocol code numberESR-14-10698
    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 SponsorUniversitätsklinikum Tübingen
    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 supportUniversitätsklinikum Tübingen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Tübingen
    B.5.2Functional name of contact pointProf. Dr. Norbert Stefan
    B.5.3 Address:
    B.5.3.1Street AddressOtfried-Müller-Straße 10
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number+49707129 80390
    B.5.5Fax number+49707129 5974
    B.5.6E-mailnorbert.stefan@med.uni-tuebingen.de
    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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca/BMS
    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.3.1Product nameDapagliflozin
    D.3.4Pharmaceutical form Film-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 INNINN-dapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB31650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    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 onglyza
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca/BMS
    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.3.1Product nameSaxagliptin Filmtabletten
    D.3.2Product code EU/1/09/545/001 – 010
    D.3.4Pharmaceutical form Film-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 INNINN-saxagliptin
    D.3.9.1CAS number 709031-78-7
    D.3.9.3Other descriptive nameSAXAGLIPTIN
    D.3.9.4EV Substance CodeSUB25220
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Yes
    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: 3
    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 Actrapid
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameActrapid®
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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.3.9.3Other descriptive nameACTRAPID
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international 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 Yes
    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 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 placeboFilm-coated tablet
    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 placeboFilm-coated 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
    Diabetes Melitus Type 2
    E.1.1.1Medical condition in easily understood language
    Investigation of effectiveness of adding the SGLT2 inhibitor dapagliflozin + the DPP-4 inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.
    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 HLGT
    E.1.2Classification code 10018424
    E.1.2Term Glucose metabolism disorders (incl diabetes mellitus)
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term 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 determine the efficacy of adding the
    SGLT2 inhibitor dapagliflozin + the DPP-4
    inhibitor saxagliptin vs placebo to revert from
    a standard basal-bolus insulin treatment
    (BBIT) regimen to a basal supported oral
    therapy (BOT) regimen in patients with type 2
    diabetes.
    Percentage of subjects achieving a HbA1c ≤ 7.5%
    and having a reversal from a BBIT to a BOT regimen
    E.2.2Secondary objectives of the trial
    To determine the efficacy of adding the
    SGLT2 inhibitor dapagliflozin + the DPP-4
    inhibitor saxagliptin vs placebo to a standard
    BBIT regimen to improve glycemic
    parameters, insulin dose, bodyweight, body fat
    mass and body fat distribution, blood pressure,
    lipid profile, microalbuminuria, quality of life,
    brain insulin resistance and blood parameters
    of cardiometabolic risk.
    To evaluate the safety and tolerability of
    adding the SGLT2 inhibitor dapagliflozin + the
    DPP-4 inhibitor saxagliptin vs placebo to a
    standard BBIT regimen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Type 2 diabetes
    •Age 18 - 75 years
    •Anti-GAD antibodies negative
    •C-peptide levels ≥ 1.5 ng/mL
    •Fasting blood glucose ≥ 126 mg/dl
    •HbA1c 8.0 – 10.5 %
    •BMI 25.0 – 45.0 kg/m2
    •Previous therapy with standard BBIT (basal insulin and at least
    once daily bolus insulin) when the bolus insulin dose is not adjusted
    to exercise or nutrient intake.
    E.4Principal exclusion criteria
    •Use of any oral antidiabetic treatment except for metformin (i.e.,
    sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2
    inhibitors) or GLP-1 analogues within the last three months prior to
    Screening
    •Repeated episodes of severe hypoglycaemia within the last six
    months prior to Screening
    •History of diabetic ketoacidosis, praecoma diabeticum, or diabetic
    coma
    •Treatment with any other investigational drug within the last three
    months before Screening
    •Acute infections within the last four weeks prior to Screening
    •Recurrent urogenital infections
    •History of pancreatitis
    •Anamnestic history of hypersensitivity to the study drugs or to
    drugs with similar chemical structures
    •History of severe or multiple allergies
    •Concomitant participation in other clinical trials
    •Type 1 diabetes
    •Cardiovascular disease
    Clinically relevant ventricular tachycardia or ventricular
    fibrillation, 3rd degree AV block or Torsades de Pointes or
    treatment with antiarrhythmic drugs.
    Percutaneous coronary intervention within the past 6 months.
    Any of the following within the past 6 months: myocardial
    infarction (MI), coronary artery bypass surgery; unstable angina;
    or stroke.
    Uncontrolled unstable angina pectoris or history of pericarditis,
    myocarditis, endocarditis.
    Congestive heart failure NYHA class III or IV.
    Increased risk of thromboembolism, e.g. subjects with a history
    of deep leg vein thrombosis or family history of deep leg vein
    thrombosis, as judged by the Investigator.
    •Malignancy including leukemia and lymphoma within the last 5y.
    •Liver disease such as cirrhosis or chronic active hepatitis.
    •Moderate or severe impaired liver function (serum AST or serum
    ALT > 2.5 x ULN, serum total bilirubin ≥ 2.0 mg/dl or serum
    albumin ≤ 3.5 g/dl)
    •Significant renal dysfunction (see also exclusion criteria laboratory
    abnormalities).
    •State after kidney transplantation
    •Endocrine disease:
    Acromegaly or treatment with growth hormone or similar drugs.
    Chronic oral or parenteral corticosteroid treatment (≥7
    consecutive days of treatment) within 8 weeks; thyroid hormone
    replacement is allowed if the dosage has been stable for at least 3
    months and the TSH is within normal limits
    •Any of the following significant laboratory abnormalities:
    eGFR (as calculated by the MDRD equation) < 60 ml/min at
    Screening
    Fasting triglycerides ≥700 mg/dl (≥7.9 mmol/l)
    •Systolic blood pressure outside the range of 100–160 mmHg or
    diastolic blood pressure above 95 mmHg at Screening
    •History of active substance abuse (including alcohol > 12g/day for
    women and >24g/day for men) within the past 2 years.
    •Pregnancy or childbearing potential without adequate
    contraception
    •Present therapy with systemic steroids
    •Known hypersensitivity to Dapagliflozin or Saxagliptin or any of
    the components of their formulation or human nasal insulin or any
    of the components of its formulation
    •Immune suppressive medication and/or immune deficiency
    syndromes
    •Presence of psychiatric disorder or intake of anti-depressive or
    anti-psychotic agents with the exception of benzodiazepines and
    SSRIs/SNRI´s
    •Potentially unreliable subjects, and those judged by the
    investigator to be unsuitable for the study (e.g. subjects needing
    assistance for the application of insulin, subjects deemed not to be
    compliant with the recommendations given during the study)
    •Contraindications for Magnetic resonance (MR) scanning such as
    persons with cardiac pacemaker and implants out of metal or
    claustrophobia
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 4: Week 0: On-site visit, dose adjustment
    Visit 6: Week 2: On-site visit, dose adjustment
    Visit 10: Week 8: On-site visit, dose adjustment
    Visit 14: Week 16: On-site visit, dose adjustment
    Visit 18.1: Week 24-day 1: Final visit, outcome parameters
    Visit 18.2: Week 24-day 2: Final visit, outcome parameters
    E.5.2Secondary end point(s)
    changes in HbA1c between groups
    • changes in hypoglycaemic events between groups
    • changes in fasting blood glucose between groups
    • changes in daily insulin dose between groups
    • changes in bodyweight between groups
    • changes in body fat content and body fat distribution, both precisely measured with MR tomography, and liver fat content, precisely measured with 1H-MR spectroscopy, and intra-nasal insulin-induced brain fMR imaging results between groups (to be discussed – decreased insulinemia and lower energy availability are expected to decrease visceral fat mass and liver fat content and to improve brain insulin resistance)
    • changes in blood pressure between groups
    • changes in the blood lipid profile between groups
    • changes in well being and disease perception between groups.
    • changes in fear of hypoglycaemia
    AEs/SAEs
    Vital signs
    Collection of clinical chemistry/haematology parameters
    ECGs. The following parameters will be recorded for each ECG: date and time of ECG, heart rate (beats/min), QT (ms), QTcB (ms), sinus rhythm (yes/no), and overall evaluation (normal/abnormal)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 4: Week 0: On-site visit, dose adjustment
    Visit 6: Week 2: On-site visit, dose adjustment
    Visit 10: Week 8: On-site visit, dose adjustment
    Visit 14: Week 16: On-site visit, dose adjustment
    Visit 18.1: Week 24-day 1: Final visit, outcome parameters
    Visit 18.2: Week 24-day 2: Final visit, outcome parameters
    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 Yes
    E.6.5Efficacy Yes
    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 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 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
    The total duration of the study for each subject will be up to 30 weeks.
    Subjects have the right to withdraw of the informed consent at any time.
    Withdrawal from investigations – Participants will not undergo study investigations if one or more of the respective inclusion criteria for the metabolic test/study investigation are not fulfilled.
    Withdrawal from documentation – Subjects who gave consent to be included in the study can withdraw their specimen at any time for any reason.
    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 months9
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    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)
    Each study participant will be provided with treatment recommendations for their general practiotioners after the end of the treatment period. If participants are not referred by a doctor, treatment advice in the respective trial site clinic should be provided.
    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 Decision2017-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-02-03
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