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    Clinical Trial Results:
    Effect of INtervention with DMR, GLP-1 and lifestyle intensification -in Subjects with insulin dePendent type 2 diabetes- on Insulin Requirement and mEtabolic parameters

    Summary
    EudraCT number
    		 2017-000349-30
    Trial protocol
    		 NL  
    Global end of trial date
    16 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions
    Summary report(s)
    		 Published results INSPIRE

    Trial information

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    Trial identification
    Sponsor protocol code
    NL60669
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ABR nummer: NL60669
    Sponsors
    Sponsor organisation name
    Amsterdam UMC
    Sponsor organisation address
    Meibergdreef 9 , Amsterdam , Netherlands, 1105 AZ
    Public contact
    Suzanne Meiring, Academic Medical Center, +31 21357593, s.meiring@amsterdamumc.nl
    Scientific contact
    Annieke van Baar, Academic Medical Center, +31 205661613, a.c.vanbaar@amc.nl
    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
    16 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this pilot study is to evaluate the efficacy of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulindependent type 2 diabetes. Study success is defined as insulin independence at 6 months after DMR with an HbA1c level of ≤ 7.5%.
    Protection of trial subjects
    Liraglutide is already a approved for the treatment of type 2 diabetes. We used this medication in the same patient population and the same dosage as is registered. Because of side effects are minimal and mostly self-limitating, there were no additional meaures taken for protection, because it was not necessary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    12
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 3.1 Subject Recruitment The investigational site (AMC) may utilize a number of methods to recruit potential subjects into the study including evaluation of existing subjects from their clinical practice, referrals from other physicians and recruitment via external advertising. Advertising materials need to be reviewed and approved by the Independe

    Pre-assignment
    Screening details
    		 1. Diagnosed with Type 2 Diabetes 2. 28 -75 years of age 3. Treatment with long acting insulin ≤ 5 years 4. On daily long acting insulin dose ≤ 1 U/kg 5. BMI ≥ 24 and ≤ 40 kg/m2 6. HbA1c ≤ 8.0% (64 mmol/mol) 7. Fasting C-peptide ≥ 0.5 nmol/L (1.5 ng/ml)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.8mg once daily

    Number of subjects in period 1
    		Overall trial
    Started
    16
    Completed
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 16 16
    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
        median (inter-quartile range (Q1-Q3))
    		 61 (55 to 67) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 10 10
    Duration of type 2 diabetes
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 11 (8 to 15) -
    BMI
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    		 28.8 (26.5 to 31.7) -
    HbA1c
    Units: percent
        median (inter-quartile range (Q1-Q3))
    		 7.5 (7.1 to 7.9) -
    Fasting Plasma Glucose
    Units: mmol/l
        median (inter-quartile range (Q1-Q3))
    		 10.1 (8.9 to 12) -
    Subject analysis sets

    Subject analysis set title
    Analysis complete trial population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Complete patient population analysis. All patient were included in the analysis. All patients underwent DMR and started with liraglutide.

    Subject analysis sets values
    		 Analysis complete trial population
    Number of subjects
    16
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    Gender categorical
    Units: Subjects
        Female
    6
        Male
    10
    Duration of type 2 diabetes
    Units: years
        median (inter-quartile range (Q1-Q3))
    BMI
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    HbA1c
    Units: percent
        median (inter-quartile range (Q1-Q3))
    Fasting Plasma Glucose
    Units: mmol/l
        median (inter-quartile range (Q1-Q3))

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Subject analysis set title
    Analysis complete trial population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Complete patient population analysis. All patient were included in the analysis. All patients underwent DMR and started with liraglutide.

    Primary: % of patients HbA1c <7.6% at 6 months

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    End point title
    		 % of patients HbA1c <7.6% at 6 months
    End point description
    End point type
    Primary
    End point timeframe
    6 months after DMR
    End point values
    		 Overall trial Analysis complete trial population
    Number of subjects analysed
    16
    16
    Units: number of patients
        number (not applicable)
    16
    16
    Statistical analysis title
    		 Analysis complete trial
    Comparison groups
    Overall trial v Analysis complete trial population
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    18 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Toetsingonline
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Complete study population
    Reporting group description
    		 -

    Serious adverse events
    		 Complete study population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Deep venous thrombosis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma exacerbation
    Additional description: For which ER presentation/admission was necessary
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankle fracture
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
    Additional description: For which hospital admission was necessary
         subjects affected / exposed
    1 / 16 (6.25%)
         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
    		 Complete study population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 16 (93.75%)
    Vascular disorders
    Ulcus dig II left
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Orthostatic hypotension
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Iron deficiency anemia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Dizziness
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Immune system disorders
    Hay fever
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 16 (31.25%)
         occurrences all number
    5
    Abdominal pain
         subjects affected / exposed
    7 / 16 (43.75%)
         occurrences all number
    9
    Diarrhea
         subjects affected / exposed
    7 / 16 (43.75%)
         occurrences all number
    8
    Superficial duodenal mucosal laesions
    Additional description: prior to procedure and start medication
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Obstipation
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Loss of appetite
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Mild esofagitis
    Additional description: Found during follow-up endoscopy
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Barrett segment
    Additional description: Found during DMR procedure, follow-up planned
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Reflux
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Dark stool
    Additional description: without alarm symptoms
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Asthma exacerbation
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Throat infection
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Renal and urinary disorders
    Benign cystic and prostate polyps
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    2
    Endocrine disorders
    Hyperglycemia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Rotatorcuff rupture
    Additional description: After cycling accident
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Dumbness en tingling limbs
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Myalgia shoulders legs
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Muscle ache
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Infections and infestations
    Flu with flu-like symptoms
         subjects affected / exposed
    5 / 16 (31.25%)
         occurrences all number
    6
    Testicular infection
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Fungal infection vagina
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Face infection
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Low energy level
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2018
    Change in patient information sheet, regarding body material collection and storage.
    14 Dec 2018
    Addition of extra MRI assessment.
    18 Mar 2019
    Prolongation of the follow-up from 1 year to 2 years

    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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