Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomised, double-masked, placebo-controlled exploratory study to evaluate pharmacodynamics, safety, and tolerability of orally administered BI 1026706 for 12 weeks in patients with mild visual impairment due to centre-involved diabetic macular oedema (DME)

    Summary
    EudraCT number
    		 2015-003529-33
    Trial protocol
    		 DE   HU   GB   GR   ES   BE   PT  
    Global end of trial date
    24 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Oct 2018
    First version publication date
    20 Oct 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1320.22
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02732951
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This trial investigated the mechanism and the pharmacodynamics of orally administered BI 1026706 (100 milligram (gm) twice daily (bid)) in the treatment of patients with mild vision impairment due to centre-involved DME.
    Protection of trial subjects
    As per judgment of the investigator, rescue medication was administered in case of clinically significant worsening of the disease, and could be considered in the event of vision loss of ≥5 letters or in the event of Central subfield foveal thickness (CSFT) increase of ≥10% as compared with the previous visit confirmed by the Central Reading Centre (CRC). Data obtained after the start of rescue medication were excluded from the primary analysis of the primary endpoint.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jun 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Greece: 21
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Portugal: 27
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 16
    Worldwide total number of subjects
    169
    EEA total number of subjects
    169
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    91
    From 65 to 84 years
    75
    85 years and over
    3

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was randomised, double-blind, placebo-controlled, parallel-group trial to evaluate pharmacodynamics, safety and tolerability of orally administered Boehringer Ingelheim (BI) 1026706 for 12 weeks in patients with Diabetic Macular Oedema (DME). Of the 169 enrolled patients, 105 were randomised.

    Pre-assignment
    Screening details
    		 All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were violated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Assessor, Subject
    Blinding implementation details
    This was a double-blind trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo matching to BI 1026706
    Arm description
    		 Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.

    Arm title
    		 BI 1026706
    Arm description
    		 Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 1026706
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.

    Number of subjects in period 1 [1]
    		Placebo matching to BI 1026706 BI 1026706
    Started
    53
    52
    Completed
    48
    46
    Not completed
    5
    6
         Adverse event, non-fatal
    4
    4
         Lost to follow-up
    -
    1
         Other than listed
    1
    -
         Protocol deviation
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo matching to BI 1026706
    Reporting group description
    		 Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.

    Reporting group title
    BI 1026706
    Reporting group description
    		 Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.

    Reporting group values
    		 Placebo matching to BI 1026706 BI 1026706 Total
    Number of subjects
    		 53 52 105
    Age categorical
    Units: Subjects
    Age Continuous
    Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.
    Units: years
        arithmetic mean (standard deviation)
    		 62.2 ± 9.7 63.9 ± 8.7 -
    Sex: Female, Male
    Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.
    Units: Subjects
        Female
    		 14 14 28
        Male
    		 39 38 77
    Race (NIH/OMB)
    Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 38 47 85
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 14 5 19
    Ethnicity (NIH/OMB)
    Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.
    Units: Subjects
        Hispanic or Latino
    		 4 4 8
        Not Hispanic or Latino
    		 35 43 78
        Unknown or Not Reported
    		 14 5 19

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo matching to BI 1026706
    Reporting group description
    		 Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.

    Reporting group title
    BI 1026706
    Reporting group description
    		 Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.

    Primary: Change from baseline in Central Subfield Foveal Thickness (CSFT) at Week 12

    		 Close Top of page
    End point title
    		 Change from baseline in Central Subfield Foveal Thickness (CSFT) at Week 12
    End point description
    The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean. Full analysis set (FAS): FAS includes all patients who were randomised, treated with at least 1 dose of BI 1026706 or placebo, and with a baseline and at least one post randomisation central subfield foveal thickness (CSFT) measurement.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo matching to BI 1026706 BI 1026706
    Number of subjects analysed
    47 [1]
    47 [2]
    Units: Micrometre [μm]
        arithmetic mean (standard deviation)
    -6.19 ± 11.61
    10.26 ± 11.64
    Notes
    [1] - FAS
    [2] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Null hypothesis = The CSFT change from baseline at Week 12 is equal in both groups
    Comparison groups
    BI 1026706 v Placebo matching to BI 1026706
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.3199
    Method
    		 Mixed model for repeated measurements
    Parameter type
    		 Adjusted Mean
    Point estimate
    16.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.23
         upper limit
    		 49.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    16.45
    Notes
    [3] - Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors. Kenward−Roger approximation was used for denominator degrees of freedom.

    Secondary: Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs)

    		 Close Top of page
    End point title
    		 Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs)
    End point description
    Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs) comparing the BI 1026706 treatment group with the placebo group is presented. Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.
    End point type
    Secondary
    End point timeframe
    From first drug administration until 4 days after last drug administration, up to 89 days.
    End point values
    		 Placebo matching to BI 1026706 BI 1026706
    Number of subjects analysed
    53 [4]
    52 [5]
    Units: Count of participants
        Total with SAEs|
    2
    2
        Investigator defined drug-related AE|
    7
    7
        AESIs|
    0
    1
    Notes
    [4] - TS
    [5] - TS
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first drug administration until 4 days after last drug administration, up to 89 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo matching to BI 1026706
    Reporting group description
    		 Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.

    Reporting group title
    BI 1026706
    Reporting group description
    		 Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.

    Serious adverse events
    		 Placebo matching to BI 1026706 BI 1026706
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 53 (3.77%)
    7 / 52 (13.46%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Red blood cell count decreased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosuria
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Reactive perforating collagenosis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Localised infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo matching to BI 1026706 BI 1026706
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 53 (22.64%)
    14 / 52 (26.92%)
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 52 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 53 (1.89%)
    4 / 52 (7.69%)
         occurrences all number
    2
    7
    Somnolence
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 52 (1.92%)
         occurrences all number
    3
    1
    Eye disorders
    Visual acuity reduced
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 53 (7.55%)
    6 / 52 (11.54%)
         occurrences all number
    4
    6

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2016
    Exclusion Criterion and the numbering of the subsequent exclusion criteria was adjusted. A footnote was added providing further details for this exclusion criterion.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 05:10:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA