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    Summary
    EudraCT Number:2017-001807-62
    Sponsor's Protocol Code Number:FIDAM-DA-2017-05-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-26
    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 number2017-001807-62
    A.3Full title of the trial
    Evaluation of different algorithms for the calculation of the prandial insulin dose, considering the fat and protein content of the meal - Effects on postprandial glucose in type 1 diabetes patients with insulin pump therapy
    Untersuchung unterschiedlicher Algorithmen zur Berechnung der prandialen Insulindosis unter Berücksichtigung des Fett- und Eiweißgehalts der Mahlzeit - Auswirkungen auf den postprandialen Glukoseverlauf bei Typ 1 Diabetes-patienten mit einer Insulinpumpentherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of different algorithms for the calculation of the prandial insulin dose, considering the fat and protein content of the meal
    Auswirkung unterschiedlicher Algorithmen zur Berechnung des prandialen Insulins unter Berücksichtigung von Fett-Protein-Einheiten auf den post-prandialen Glukoseverlauf
    A.4.1Sponsor's protocol code numberFIDAM-DA-2017-05-001
    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 SponsorForschungsinstitut der Diabetes-Akademie Bad Mergentheim e.V.
    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 supportForschungsinstitut der Diabetes-Akademie Bad Mergentheim e.V.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiabetes-Akademie Bad Mergentheim e.V.
    B.5.2Functional name of contact pointProf. Dr. Thomas Haak
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Klotzbücher-Str. 12
    B.5.3.2Town/ cityBad Mergentheim
    B.5.3.3Post code97980
    B.5.3.4CountryGermany
    B.5.4Telephone number4907931594101
    B.5.5Fax number4907931563217
    B.5.6E-mailhaak@diabetes-zentrum.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.2.1.2Country 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.3.1Product namefast acting insulin to be used in an insulin pump
    D.3.4Pharmaceutical form Solution for injection in cartridge
    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 GLULISINE
    D.3.9.1CAS number 207748-29-6
    D.3.9.4EV Substance CodeSUB20054
    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 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.2.1.2Country 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.3.1Product namefast acting insulin to be used in an insulin pump
    D.3.4Pharmaceutical form Solution for injection in cartridge
    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.3.11 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 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.2.1.2Country 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.3.1Product namefast acting insulin to be used in an insulin pump
    D.3.4Pharmaceutical form Solution for injection in cartridge
    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 ASPART
    D.3.9.1CAS number 116094-23-6
    D.3.9.4EV Substance CodeSUB08195MIG
    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 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: 4
    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.2.1.2Country 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.3.1Product namefast acting insulin to be used in an insulin pump
    D.3.4Pharmaceutical form Solution for injection in cartridge
    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 HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.4EV Substance CodeSUB08197MIG
    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 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
    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
    Typ 1 Diabetes
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes mellitus
    Typ 1 Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    In this experimental study the effect of different algorithms for the
    calculation of the prandial insulin dose on the postprandial glucose
    control will be be examined.
    An algorithm taking into account only the carbohydrate content of the
    meal (standard treatment in type 1 diabetes) will be tested against two
    algorithms takeing into account the fat and protein content of the meal
    (consideration of fat-protein units).
    The glucose development is monitored continuously by means of an
    interstitial glucose monitoring (FGM).
    The aim is to investigate with which rule for calculation of the prandial
    insulin dose a better postprandial glucose control can be achieved, with
    a continuous avoidance of postprandial hyperglycemic peaks and
    hypoglycemic events.
    In dieser experimentellen Studie soll die Auswirkung unterschiedlicher
    Algorithmen zur Berechnung der prandialen Insulindosis auf den
    postprandialen Glukoseverlauf überprüft werden. Es soll eine
    Anpassungsregel unter ausschließlicher Berücksichtigung des
    Kohlenhydratanteils der Mahlzeit, wie sie der Standardbehandlung bei
    Typ 1 Diabetes entspricht, gegen zwei Anpassungsregeln unter
    Berücksichtigung des Fett- und Eiweißgehalts der Mahlzeit
    (Berücksichtigung von Fett-Protein-Einheiten) getestet werden. Die
    Kontrolle des Glukoseverlaufs erfolgt kontinuierlich mit Hilfe einer
    interstitiellen Glukosemessung (Flash Glukose Monitoring, FGM).
    Ziel ist es, zu überprüfen, mit welcher Anpassungsregel der prandialen
    Insulindosis eine bessere postprandiale Glukosekontrolle erreicht
    werden kann, bei einer kontinuierlichen Vermeidung von
    postprandialen hyperglykämischen Spitzen und hypoglykämischen
    Ereignissen.
    E.2.2Secondary objectives of the trial
    Not applicable
    Nicht zutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type 1 Diabetes mellitus
    Treatment with an insulin pump regimen (CSII)
    Age ≥ 18 years to ≤ 70 years
    German speaking
    Written informed consent
    Vorliegen eines Typ 1 Diabetes mellitus
    Durchführung einer Insulinpumpentherapie (CSII)
    Alter ≥ 18 Jahre bis ≤ 70 Jahre
    Deutschkenntnisse in Wort und Schrift
    Vorliegen einer schriftlichen Einwilligungserklärung
    E.4Principal exclusion criteria
    Severe general diseases or bedriddenness
    Anamnestic known severe psychiatric disorder according to ICD-10 (e.g., dementia, schizophrenia, eating disorder)
    Patients with a known history of gastroenterology disorder (such as ulcerative colitis, Crohn's disease, celiac disease, or functional disorders such as functional dyspepsia, irritable bowel syndrome)
    Restricted renal function (Creatinin-Clearance / GFR < 60 ml/min)
    Heart attack, stroke / TIA or vascular surgery within the past 6 months
    Severe retinopathy with the need for laser coagulation (still outstanding)
    Ingestion of systemic steroids
    Known allergy to patch
    For women: Pregnancy or lactation
    Person dependent on the sponsor or clinical investigator
    Limited legal capacity or legal assistance
    Participation in other clinical trials with - approved or not authorized - medicinal products or medical devices
    Schwere Allgemeinerkrankungen oder Bettlägerigkeit
    Anamnestisch bekannte schwere psychiatrische Erkrankung entsprechend ICD-10 (z.B. Demenz, Schizophrenie, Essstörung)
    Anamnestisch bekannte gastroenterologische Erkrankung (Darmerkrankungen, wie z.B. Colitis ulcerosa, Morbus Crohn und Zöliakie, oder Funktionsstörungen, wie z.B. funktionelle Dyspepsie, Reizdarmsyndrom)
    Eingeschränkte Nierenfunktion (Kreatinin-Clearance / GFR < 60 ml/min)
    Herzinfarkt, Schlaganfall/TIA oder Gefäß-OP innerhalb der vergangenen 6 Monate
    Schwere Retinopathie mit Notwendigkeit der Laserkoagulation (noch ausstehend)
    Einnahme von systemischen Steroiden
    Bekannte Allergie auf Pflaster
    Bei Frauen: Schwangerschaft oder Stillzeit
    Vom Sponsor oder vom klinischen Prüfer abhängige Person
    Eingeschränkter Geschäftsfähigkeit oder gesetzliche Betreuung
    Teilnahme an anderen klinischen Prüfungen mit - zugelassenen oder mit nicht zugelassenen - Arzneimitteln oder Medizinprodukten
    E.5 End points
    E.5.1Primary end point(s)
    Primary study outcome is the percentage of glucose values in the target range of 70 to 180 mg / dl ("time in range") over a period of 8 hours after taking a standardized test meal.
    Primärer Studienoutcome ist der prozentuale Anteil der Glukosewerte im Zielbereich von 70 bis 180 mg/dl ("time in range") im Zeitraum von 8 Stunden nach Einnahme einer standardisierten Testmahlzeit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous interstitial glucose measurement over a period of eight hours after the start of the test meal.
    Kontinuierliche interstitielle Glukosemessung über einen Zeitraum von acht Stunden nach Beginn der Testmahlzeit.
    E.5.2Secondary end point(s)
    the percentage of glucose values below 70 and above 180 mg/dl, respectively, in the period of 8 hours after the test meal,
    the area under the curve of glucose over 8 hours after taking the test meal time,
    the occurrence of hypoglycemias or hyperglycemias requiring treatment (necessity of hypoglycemia treatment or the administration of additional correction insulin).
    der prozentuale Anteil der Glukosewerte unter 70 bzw. über 180 mg/dl im Zeitraum von 8 Stunden nach Einnahme der Testmahlzeit,
    die Fläche unter der Kurve ("area under the curve") des Glukoseverlaufes über 8 Stunden nach Einnahme der Testmahlzeit,
    das Auftreten von behandlungsbedürftigen Hypoglykämien oder Hyperglykämien (Notwendigkeit der Hypoglykämiebehandlung oder der Gabe von zusätzlichem Korrekturinsulin).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuous interstitial glucose measurement over a period of eight hours after the start of the test meal.
    Kontinuierliche interstitielle Glukosemessung über einen Zeitraum von acht Stunden nach Beginn der Testmahlzeit
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Unterschiedliche Algorithmen zur Anpassung der prandialen Insulindosis
    different algorithms for calculating prandial insulin dose
    E.8.2.4Number of treatment arms in the trial3
    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
    Letzter Visit des letzten Probanden
    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 months
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state25
    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)
    None
    Eine weitere Nachbeobachtung der Studienteilnehmer nach Beendigung der klinischen Studie ist nicht vorgesehen.
    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 Decision2017-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-01
    P. End of Trial
    P.End of Trial StatusOngoing
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