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    Clinical Trial Results:
    The DIAMOND for the Treatment of Type 2 Diabetes: Can Blood Triglycerides level be the predictor for therapy efficiency?

    Summary
    EudraCT number
    		 2013-001003-36
    Trial protocol
    		 AT   IT  
    Global end of trial date
    17 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2020
    First version publication date
    02 Jan 2020
    Other versions
    Summary report(s)
    		 The DIAMOND® for the Treatment of Type 2 Diabetes: Can blood Triglycerides level be the predictor for therapy efficiency? A Multicentre, Prospective, Semi-randomized Study

    Trial information

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    Trial identification
    Sponsor protocol code
    MC-CP-TAN2012-60
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Metacure/Hobart
    Sponsor organisation address
    Route de Meyrin, Geneva, Switzerland, 1203
    Public contact
    Dr. Ricardo Aviv, Metacure Ltd, ricardoa@metacure.com
    Scientific contact
    Dr. Ricardo Aviv, Metacure Ltd, 43 6647966285, ricardoa@metacure.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
    04 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this study were: (1) to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c. (2) Examine the relationship between blood TG levels and the GCM efficacy for mechanistic purpose. (3) The effects of GCM on weight loss and associated co-morbid conditions
    Protection of trial subjects
    Enrolled subjects did not experience pain as part of the treatment. Diabetes type 2 remained under anti oral medication.
    Background therapy
    		 All patients received oral antidiabetes medications and the GCM, an electrical current applied to the stomach during meals to enhance gastric contractility and thereby increase the sensation of satiety during the emal, help reduce weight and better control hunger.
    Evidence for comparator
    		 This was a study where subjects were divided in two groups according to their level of triglycerides: normal (low) or High triglycerdides. Subjects in the high triglycreide group were further randomized and divided into two furthr groups in a double blind fashion to placebo or Fenofibrate, a drug known to lower trigylerides.
    Actual start date of recruitment
    21 Oct 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
    Serbia: 26
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Poland: 27
    Country: Number of subjects enrolled
    Greece: 1
    Worldwide total number of subjects
    59
    EEA total number of subjects
    33
    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)
    45
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Note that out of the 105 patients who signed the inform consent only 59 were implanted and entered the study phase. First patient recruited 21 Oct 2013 First patient implanted: 6 Nov 2013 Last patient implanted 17 Jun 2016 Last patient completed 17 June 2018

    Pre-assignment
    Screening details
    		 The protocol had a screening failure rate of 45% . Of a total of 59 implanted subjects 27 subjects were implanted in 5 sites throughout Poland, 26 in two sites in Serbia, 5 subjects were implanted in one site in Italy, and one patient was implanted in Greece. The most common cause for failure was appropriate glycemic control

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Baseline
    Arm description
    		 patients kept their oral anti diabetes medication
    Arm type
    		 baseline evaluations

    Investigational medicinal product name
    No Diamond implant on baseline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Not mentioned
    Dosage and administration details
    permanent

    Number of subjects in period 1
    		Baseline
    Started
    59
    Completed
    59
    Period 2
    Period 2 title
    Diamond treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Normal Triglyceride
    Arm description
    		 Patients with normal TG levels were compared to the High TG level groups
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diamond
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    Active from week 1

    Arm title
    		 High TG Fenofibrate
    Arm description
    		 Patients with Hight TG were randomized to Fenofibrate or placebo. Patients with Fenofibrate were exected to lower the TG levels, and thus behave like low Normal TG level group
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diamond
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    Active from week 1

    Arm title
    		 High Triglyceride Placebo
    Arm description
    		 Patients eith High TG randomized to placebo received only the Diamond treatment and were expected to have the least efficacy on glycemic control
    Arm type
    		 Placebo

    Investigational medicinal product name
    Diamond
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Implantation
    Dosage and administration details
    Active from week 1

    Number of subjects in period 2
    		Normal Triglyceride High TG Fenofibrate High Triglyceride Placebo
    Started
    21
    21
    17
    Completed
    21
    21
    17

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 59 59
    Age categorical
    All subjects were adults of 18 years old or more
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 45 45
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
        adults > 18 years old
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.32 ± 7.68 -
    Gender categorical
    All genderes could participate
    Units: Subjects
        Female
    		 34 34
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 patients kept their oral anti diabetes medication
    Reporting group title
    Normal Triglyceride
    Reporting group description
    		 Patients with normal TG levels were compared to the High TG level groups

    Reporting group title
    High TG Fenofibrate
    Reporting group description
    		 Patients with Hight TG were randomized to Fenofibrate or placebo. Patients with Fenofibrate were exected to lower the TG levels, and thus behave like low Normal TG level group

    Reporting group title
    High Triglyceride Placebo
    Reporting group description
    		 Patients eith High TG randomized to placebo received only the Diamond treatment and were expected to have the least efficacy on glycemic control

    Subject analysis set title
    Normal TG
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Only 1 subject did not have data at the last visit

    Subject analysis set title
    High TG Fenofibrate
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    3 subjects did not have data t the last visit

    Subject analysis set title
    High TG Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all 17 subjects havd data at the last visit

    Primary: to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c.

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    End point title
    		 to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c.
    End point description
    End point type
    Primary
    End point timeframe
    baseline vs 12 month
    End point values
    		 Normal Triglyceride High TG Fenofibrate High Triglyceride Placebo
    Number of subjects analysed
    20
    18
    17
    Units: percent volume/volume
        arithmetic mean (confidence interval 0.05%)
    7.32 (6.7 to 8.1)
    7.39 (6.7 to 8.1)
    8.07 (7.8 to 8.4)
    Statistical analysis title
    		 t-test
    Statistical analysis description
    The analysis compared ends of period measurements, specifically, the null hypothesis that there is no difference in HbA1c between baseline and 12 months post implant as tested by a two-sided 0.05 level test using a t-statistic.
    Comparison groups
    Normal Triglyceride v High Triglyceride Placebo v High TG Fenofibrate
    Number of subjects included in analysis
    55
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    A total of 68 Adverse Events were recorded in 28 subjects. 58 AE (85.2%) were considered unrelated to device function or implant procedure and included 2 SAE, 3 AE of documented hypoglycemia, 3 events of suspected hypoglycemia and one hyperglycemic event.
    Adverse event reporting additional description
    2 SAE: a,intracerebral hemorrhage occurring 2 month after the implant and b, hospitalization after suspicion of breast cancer. A patient had a fatal car accident. 3 subjects had in 39.7% of the AE (7, 9 and 11 AE each); all other subjects reported AE frequency:1 event (13 subjects), 2 events (7 subjects), 3 events (2 subjects) 4 events (2 events)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    group 1
    Reporting group description
    		 -

    Serious adverse events
    		 group 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 59 (1.69%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Stroke in evolution
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 group 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 59 (1.69%)
    Surgical and medical procedures
    Wound complication
         subjects affected / exposed
    1 / 59 (1.69%)
         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
    10 Nov 2014
    The formal written approval by the EC and all relevant correspondence pertaining to this submission have been filed in the Trial Master Files. Slight revisions to the protocol addressed guiding Ethics Committee requests as new sites were incorporated. These changes maintained however, the same endpoints, enrollment criteria and methods: 
    05 May 2015
    A second revision Rev 02c, dated 5 May 2015 was approved to reflect newly appointed sites in Australia (no patient was eventually enrolled). This version allowed the study period to start in March 2015 and continuing until successful enrollment of 65 patients with a 30% dropout. The version had additional information on risks associated with Fenofibrate, the drug used to lower Triglycerides in High TG patients randomized to Triglyceride (lowering) treatment group.
    01 Apr 2016
    A Ver 01 of the protocol was released the 1st April 2016, changing the name to MC CP TAN2016 – 60. The Rev 1 version allowed the study to run from April 2016 to April 2018, changed the amount of implanted subjects to at least 40. It also added references to recent studies with the DIAMOND system, and allowed for potential use of the DIAMOND II device (not implemented eventually). This version widened the scope of the Triglyceride effect on the DIAMOND treatment through the randomization into treatment and placebo controlled data on patients enrolled to the high TG group.

    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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