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    Clinical Trial Results:
    Effects of Linagliptin on Endothelial- , Renal-, and Retinal Function in Comparison to Placebo in Patients with Hypertension and Albuminuria

    Summary
    EudraCT number
    		 2012-004300-35
    Trial protocol
    		 DE  
    Global end of trial date
    30 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jun 2022
    First version publication date
    01 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ikfe-Lina-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Profil Mainz GmbH & Co. KG
    Sponsor organisation address
    Rheinstr. 4c, Mainz, Germany, 55116
    Public contact
    Contract Research Organisation, Clinlogix Europe GmbH, +49 61313279032, cforkel@clinlogix.de
    Scientific contact
    Contract Research Organisation, Clinlogix Europe GmbH, +49 61313279032, cforkel@clinlogix.de
    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
    22 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to investigate the effect of Linagliptin in comparison to placebo on the urine albumin-to-creatinine ratio (UACR) in patients with high blood pressure and an increased albumin excretion.
    Protection of trial subjects
    A patient will only be enrolled in the study after obtaining a written informed consent to participation. During patient information, the investigator must provide a complete explanation of the study (benefits, risks, rights and obligations) and check that the patient fulfills all of the inclusion criteria and none of the exclusion criteria
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jan 2013
    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
    Germany: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    13
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment from own database and by advertisement (Germany)

    Pre-assignment
    Screening details
    		 - Arterial hypertension - Stable antihypertensive treatment within the last 3 months - Age ≥ 45 – ≤ 80 years - Micro- or macroalbuminuria defined as UACR in morning urine > 20 mg/g in female and > 30 mg/g in male and/or arterial hypertension for more than 5 years

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo arm
    Arm description
    		 once daily administration of Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match Linagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Arm title
    		 Linagliptin arm
    Arm description
    		 once daily administration of Linagliptin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linagliptin (Trajenta)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg once daily

    Number of subjects in period 1
    		Placebo arm Linagliptin arm
    Started
    22
    21
    Completed
    22
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 43 43
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.2 ± 6.6 -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 33 33
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 171.9 ± 7.5 -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 85.9 ± 15.2 -
    Waist circumference
    Units: centimetre
        arithmetic mean (standard deviation)
    		 99.0 ± 12.1 -
    Hip circumference
    Units: centimetre
        arithmetic mean (standard deviation)
    		 102.7 ± 15.3 -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 139.8 ± 12.8 -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 79.7 ± 10.8 -
    Pulse rate
    Units: beats/min
        arithmetic mean (standard deviation)
    		 60.6 ± 10.1 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo arm
    Reporting group description
    		 once daily administration of Placebo

    Reporting group title
    Linagliptin arm
    Reporting group description
    		 once daily administration of Linagliptin

    Primary: Comparison of urine albumin-to-creatinine ratio (UACR)

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    End point title
    		 Comparison of urine albumin-to-creatinine ratio (UACR)
    End point description
    End point type
    Primary
    End point timeframe
    measurement on visit 2 and visit 5
    End point values
    		 Placebo arm Linagliptin arm
    Number of subjects analysed
    22
    21
    Units: percent
        arithmetic mean (standard deviation)
    21.2 ± 71.0
    47.6 ± 102.3
    Statistical analysis title
    		 UACR ratio / arm1:arm 2
    Comparison groups
    Placebo arm v Linagliptin arm
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 43 (2.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Bite
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 43 (58.14%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Post procedural discomfort
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Tooth fracture
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Radial head dislocation
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Eye disorders
    Eye allergy
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Foot deformity
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Eczema infected
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    4 / 43 (9.30%)
         occurrences all number
    4
    Laryngitis
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Mastitis
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    8 / 43 (18.60%)
         occurrences all number
    8
    Urinary tract infection
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    2 / 43 (4.65%)
         occurrences all number
    2
    Hypoglycaemia
         subjects affected / exposed
    1 / 43 (2.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jun 2013
    changes regarding two inclusion criteria

    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
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    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.

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