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    Summary
    EudraCT Number:2019-002758-21
    Sponsor's Protocol Code Number:DTCI-PIT-001
    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:2019-07-11
    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 number2019-002758-21
    A.3Full title of the trial
    PILOT STUDY FOR EVALUATION OF THE IMPACT OF PULSATILE INSULIN INFUSION THERAPY ON VASCULAR FUNCTION IN PATIENTS WITH TYPE 1 AND TYPE 2 DIABETES MELLITUS
    Pilotstudie zur Bewertung der Auswirkungen einer pulsatilen Insulininfusionstherapie auf die Gefäßfunktion bei Patienten mit Typ 1 und Typ 2 Diabetes mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pulsatile insulin infusion therapy (PIT) for diabetics
    Pulsierende Insulininfusionstherapie (PIT) for diabetics
    A.4.1Sponsor's protocol code numberDTCI-PIT-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 SponsorInnovative Diabetes Treatments Studies LLC
    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 supportInnovative Diabetes Treatments Studies LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInnovative Diabetes Treatments Studies LLC.
    B.5.2Functional name of contact pointPresident of IDTS
    B.5.3 Address:
    B.5.3.1Street Address2825 Third Avenue, Bronx
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10455
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012022626601
    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 Huminsulin Normal 100
    D.2.1.1.2Name of the Marketing Authorisation holderLilly Germany GmbH
    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 nameHuminsulin Normal 100
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.3.9.3Other descriptive nameHuminsulin Normal 100
    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 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
    treatment of long-term effects of Diabetes Type 1 and Type 2
    Behandlung von Spätfolgen bei Diabetes Typ 1 und Typ 2
    E.1.1.1Medical condition in easily understood language
    treatment of long-term effects of Diabetes Type 1 and Type 2
    Behandlung von Spätfolgen bei Diabetes Typ 1 und Typ 2
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    Impact of PIT on endothelial function and renal failure
    Untersuchung der Wirkung von PIT auf vaskuläre Endothelfunktion und die Nierenschädigung
    E.2.2Secondary objectives of the trial
    • impact of PIT on renal function parameters
    • impact of PIT on retinopathy
    • impact of PIT on neuropathy
    • impact of PIT on gylcemic control (HbA1c)
    • impact of PIT on Quality of Life
    • Demonstrate safety of PIT
    - Untersuchung der Wirkung von PIT auf die Nierenwerte
    - Untersuchung der Wirkung von PIT auf die Retinopathie
    - Untersuchung der Wirkung von PIT auf Neuropathie
    - Untersuchung des Einflusses von PIT auf die glykämische Kontrolle (HbA1c)
    - Untersuchung des Einflusses von PIT auf die Lebensqualität
    - Nachweis der Sicherheit von PIT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female > 18 years ≤70
    • Diagnosed with Type 1 or 2 Diabetes ≥ 2 years
    • HbA1c <10%
    • Nephropathy with GFR between 30 and 60 mL/min/1,73m2 or < 75 GFR together with proteinuria and/or elevated creatinine levels
    • Patient is naïve to pulsatile insulin treatment
    • Stable insulin treatment for at least the last 3 months
    • Männer oder Frauen, 18 Jahre oder älter
    • Type 1 oder Typ 2 Diabetes seit mind. 2 Jahren diagnostiziert
    • HbA1c <10%
    • Nierenschädigung (GFR von 30 - 60 oder GFR < 75 mit Proteinuria)
    • Keine vorausgegangene Behandlung mit PIT
    E.4Principal exclusion criteria
    1. Patients participating in another investigational drug study
    2. Current or history of dialysis therapy
    3. Anemia with HgB < 10 g/dL
    4. Unstable significant cardiovascular disease with admission to emergency room or hospital in last 45 days
    5. Patients with diagnosed renal failure from non-diabetic etiology
    6. Pregnancy or breast feeding
    7. Patient unwillingness to use a CGM device, or inability (with or without family assistance) to replace the sensor every two weeks on the study CGM device
    8. Drug or alcohol abuse
    9. Sexually active woman of childbearing age not practicing birth control by accepted methods
    10. Lack of compliance or other reason that in the discretion of the investigator precludes satisfactory participation in the study
    11. Any severe illness preventing participation in the study per protocol (in the discretion of the investigator)
    • Patienten, die an anderen AMG Studien mit Prüfpräparaten teilnehmen.
    • Dialyse
    • Anämie mit HgB < 10 g/dL
    • Instabile Herz-Kreislauf-Erkrankungen mit Krankenhausaufenthalt oder Behandlung in der Notaufnahme in den vergangenen 45 Tagen.
    • Patienten mit eine nicht-diabetischen Nierenschädigung
    • Schwangere und/oder stillende Frauen
    • Unwilligkeit oder Unfähigkeit des Patienten, ein CGM-Gerät zu benutzen.
    • Drogen- oder Alkoholmissbrauch
    • Sexuell aktive Frauen im gebärfähigen Alter, die keine anerkannten Kontrazeptiva benutzen
    • Fehlende Compliance oder ähnliche Gründe die eine zufriedenstellende Teilnahme an der Studiendurchführung verhindern würde, nach ermessen des Prüfarztes.
    • Andere schwere Erkrankungen, die die Durchführung regulärer Visiten verhindern könnten
    E.5 End points
    E.5.1Primary end point(s)
    endothelial function
    renal failure
    vaskuläre Endothelfunktion
    Nierenschädigung
    E.5.1.1Timepoint(s) of evaluation of this end point
    endothelial function (Visit 2, 6, 10, and 14)
    renal failure (Visit 2 and 14)
    vaskuläre Endothelfunktion (Visite 2, 6, 10, und 14)
    Nierenschädigung (Visite 2 und 14)
    E.5.2Secondary end point(s)
    Change from baseline (V2) to endpoint (V14) in
    Laboratory parameters for renal function (GFR, creatinine, proteinurea)
    - Sensory nerve function (pathtester, tuning fork)
    - Retinopathy assessment results (RetinaVue device)
    - HbA1c
    - Laboratory panel for insulin resistance and chronic systemic inflammation (glucose, RBP4,angiopoetin2, adiponectin, IL-6, hsCRP, glucagon, insulin, c-peptide, and intact Proinsulin)
    - Quantitative mRNA expression of eNOS and MAPK
    - DTSQ questionnaire
    - Laboratory safety parameters
    Änderungen von Visite 2 bis zu Abschluß der Studie (V14)
    - Laborparameter für die Nierenfunktion (GFR, Kreatinin, Proteinharnstoff)
    - Funktion der sensorischen Nerven (Pathtester, Stimmgabel)
    - Ergebnisse der Beurteilung der Retinopathie (RetinaVue-Gerät)
    - HbA1c
    -Laborwerte zur Bestimmung des Schweregrads der Insulinresistenz und chronische systemische Entzündungen (Glukose, RBP4, Angiopoetin2, Adiponectin, IL-6, hsCRP, Glukagon, Insulin, C-Peptid und intaktes Proinsulin)
    - Quantitative mRNA-Expression von eNOS und MAPK )
    - DTSQ-Fragebogen
    - genereller Gesundheitszustand anhand von Laborwerten
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline (V2) to endpoint (V14) in
    Laboratory parameters for renal function (GFR, creatinine, proteinurea) (Visit 2 and 14)
    - Sensory nerve function (pathtester, tuning fork) (Visit 2, 6, 10, and 14)
    - Retinopathy assessment results (RetinaVue device) (Visit 2, 6, 10, and 14)
    - HbA1c (Visit 2 and 14)
    - Laboratory panel for insulin resistance and chronic systemic inflammation (glucose, RBP4,angiopoetin2, adiponectin, IL-6, hsCRP, glucagon, insulin, c-peptide, and intact Proinsulin) (Visit 2 and 14)
    - Quantitative mRNA expression of eNOS and MAPK (Visit 2 and 14)
    - DTSQ questionnaire (Visit 2 and 14)
    - Laboratory safety parameters (Visit 2 and 14)
    Änderungen von Visite 2 bis zu Abschluß der Studie (V14)
    - Laborparameter für die Nierenfunktion (GFR, Kreatinin, Proteinharnstoff) (Visite 2 und 14)
    - Funktion der sensorischen Nerven (Pathtester, Stimmgabel) (Visite 2, 6, 10, und 14)
    - Ergebnisse der Beurteilung der Retinopathie (RetinaVue-Gerät) (Visite 2, 6, 10, und 14)
    - HbA1c (Visite 2 und 14)
    -Laborwerte zur Bestimmung des Schweregrads der Insulinresistenz und chronische systemische Entzündungen (Glukose, RBP4, Angiopoetin2, Adiponectin, IL-6, hsCRP, Glukagon, Insulin, C-Peptid und intaktes Proinsulin) (Visite 2 und 14)
    - Quantitative mRNA-Expression von eNOS und MAPK (Visite 2 und 14)
    - DTSQ-Fragebogen (Visite 2 und 14)
    - genereller Gesundheitszustand anhand von Laborwerten (Visite 2 und 14)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    Last patient out
    letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    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.1.1.1In 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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 48
    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)
    No post trial treatment is planned
    Es ist keine Behandlung geplant die über das Studienende hinaus geht
    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 Decision2019-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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