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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients with Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

    Summary
    EudraCT number
    		 2014-005623-27
    Trial protocol
    		 SE   GB   BE  
    Global end of trial date
    09 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2019
    First version publication date
    17 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RM-131-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02357420
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan Sales, LLC
    Sponsor organisation address
    5 Giralda Farms, Madison, United States, NJ 07940
    Public contact
    Clinical Trials Registry Team, Allergan plc, 001 877‐277‐8566, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan plc, 001 862-261-7000, IR-CTRegistration@Allergan.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
    09 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effect of relamorelin on vomiting episodes in participants with diabetic gastroparesis (DG).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jan 2015
    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
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 368
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Poland: 15
    Worldwide total number of subjects
    393
    EEA total number of subjects
    21
    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)
    286
    From 65 to 84 years
    107
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total 393 participants were randomised and received study treatment, and 334 participants completed the study. Five participants who received study drug but discontinued prematurely were summarised as completing the study because they fulfilled the Visit 8 (Week 12) assessments as per protocol.

    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, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo SC by injection, BID, in the morning (prior to breakfast) and evening (prior to the evening meal) for 12 weeks.

    Arm title
    		 Relamorelin 10 μg
    Arm description
    		 Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relamorelin
    Investigational medicinal product code
    RM-131
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received relamorelin 10 μg SC by injection, BID, in the morning (prior to breakfast) and evening (prior to the evening meal) for 12 weeks.

    Arm title
    		 Relamorelin 30 μg
    Arm description
    		 Relamorelin 30 μg was administered SC by injection BID for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relamorelin
    Investigational medicinal product code
    RM-131
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received relamorelin 30 μg SC by injection, BID, in the morning (prior to breakfast) and evening (prior to the evening meal) for 12 weeks.

    Arm title
    		 Relamorelin 100 μg
    Arm description
    		 Relamorelin 100 μg was administered SC by injection BID for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relamorelin
    Investigational medicinal product code
    RM-131
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received relamorelin 100 μg SC by injection, BID, in the morning (prior to breakfast) and evening (prior to the evening meal) for 12 weeks.

    Number of subjects in period 1
    		Placebo Relamorelin 10 μg Relamorelin 30 μg Relamorelin 100 μg
    Started
    104
    98
    109
    82
    Full Analysis Set (FAS)
    104
    98
    109
    81
    Completed
    92
    86
    93
    63
    Not completed
    12
    12
    16
    19
         Adverse Event
    3
    3
    8
    9
         Withdrawn Consent
    4
    8
    6
    6
         Investigator Decision
    1
    -
    -
    -
         Lost to follow-up
    3
    -
    2
    3
         Protocol Non-compliance
    -
    -
    -
    1
         Prohibited Medication
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.

    Reporting group title
    Relamorelin 10 μg
    Reporting group description
    		 Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.

    Reporting group title
    Relamorelin 30 μg
    Reporting group description
    		 Relamorelin 30 μg was administered SC by injection BID for 12 weeks.

    Reporting group title
    Relamorelin 100 μg
    Reporting group description
    		 Relamorelin 100 μg was administered SC by injection BID for 12 weeks.

    Reporting group values
    		 Placebo Relamorelin 10 μg Relamorelin 30 μg Relamorelin 100 μg Total
    Number of subjects
    		 104 98 109 82 393
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 79 64 82 61 286
        Elderly (From 65-84 years)
    		 25 34 27 21 107
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.7 ( 11.9 ) 59.3 ( 10.2 ) 56.0 ( 11.7 ) 57.1 ( 11.0 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 64 59 65 57 245
        Male
    		 40 39 44 25 148

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.

    Reporting group title
    Relamorelin 10 μg
    Reporting group description
    		 Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.

    Reporting group title
    Relamorelin 30 μg
    Reporting group description
    		 Relamorelin 30 μg was administered SC by injection BID for 12 weeks.

    Reporting group title
    Relamorelin 100 μg
    Reporting group description
    		 Relamorelin 100 μg was administered SC by injection BID for 12 weeks.

    Primary: Change from Baseline to Week 12 in Weekly Vomiting Episodes

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    End point title
    		 Change from Baseline to Week 12 in Weekly Vomiting Episodes
    End point description
    Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement. Full Analysis Set (FAS) included all randomised participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). ‘n' is the number of participants with data available at the given time-point.
    End point type
    Primary
    End point timeframe
    7 days prior to Day 1 for Baseline to 7 days prior to Week 12
    End point values
    		 Placebo Relamorelin 10 μg Relamorelin 30 μg Relamorelin 100 μg
    Number of subjects analysed
    104
    98
    109
    81
    Units: vomiting episodes per week
    arithmetic mean (standard deviation)
        Baseline (n=85,81,86,56)
    5.7 ( 6.0 )
    7.7 ( 17.2 )
    6.9 ( 10.3 )
    4.8 ( 5.2 )
        Change from Baseline to Week 12 (n=85,81,86,56)
    -2.9 ( 5.8 )
    -3.7 ( 12.5 )
    -3.8 ( 7.6 )
    -1.1 ( 13.5 )
    Statistical analysis title
    		 Relamorelin 10 μg vs Placebo
    Comparison groups
    Placebo v Relamorelin 10 μg
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36 [1]
    Method
    		 MMRM
    Confidence interval
    Notes
    [1] - Measures mixed effects model (MMRM) analysis included treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates with unstructured variance-covariance correlation matrix.
    Statistical analysis title
    		 Relamorelin 30 μg vs Placebo
    Comparison groups
    Placebo v Relamorelin 30 μg
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25 [2]
    Method
    		 MMRM
    Confidence interval
    Notes
    [2] - MMRM analysis included treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates with unstructured variance-covariance correlation matrix.
    Statistical analysis title
    		 Relamorelin 100 μg vs Placebo
    Comparison groups
    Placebo v Relamorelin 100 μg
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.59 [3]
    Method
    		 MMRM
    Confidence interval
    Notes
    [3] - MMRM analysis included treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates with unstructured variance-covariance correlation matrix.

    Secondary: Change from Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)

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    End point title
    		 Change from Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)
    End point description
    The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0=“no” (symptom) and 10=“worst possible” (symptom). Early satiety was assessed on a 5-item scale with 1=“Only 1 or 2 bites” and 5=“All of a normal-sized meal”; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement. FAS population. ‘n' is the number of participants with data available at the timepoint.
    End point type
    Secondary
    End point timeframe
    7 days prior to Day 1 for Baseline to 7 days prior to Week 12
    End point values
    		 Placebo Relamorelin 10 μg Relamorelin 30 μg Relamorelin 100 μg
    Number of subjects analysed
    104
    98
    109
    81
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=88,86,91,63)
    21.4 ( 6.7 )
    21.8 ( 6.9 )
    21.1 ( 6.0 )
    22.3 ( 6.2 )
        Change from Baseline to Week 12 (n=88,86,91,63)
    -5.4 ( 8.1 )
    -7.7 ( 7.8 )
    -7.5 ( 7.4 )
    -8.9 ( 8.3 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time

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    End point title
    		 Change from Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time
    End point description
    GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement. FAS included all randomised participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). ‘n' is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 12
    End point values
    		 Placebo Relamorelin 10 μg Relamorelin 30 μg Relamorelin 100 μg
    Number of subjects analysed
    104
    98
    109
    81
    Units: minutes
    arithmetic mean (standard deviation)
        Baseline (n=89,83,92,63)
    127.1 ( 36.5 )
    126.8 ( 37.6 )
    128.6 ( 35.9 )
    133.6 ( 35.4 )
        Change from Baseline to Week 12 (n=88,82,92,61)
    0.0 ( 38.5 )
    -12.7 ( 38.1 )
    -12.8 ( 36.5 )
    -13.6 ( 40.5 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 98 days
    Adverse event reporting additional description
    Safety set included all the participants who were randomised and received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo-matching relamorelin was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks.

    Reporting group title
    Relamorelin 10 μg
    Reporting group description
    		 Relamorelin 10 microgram (μg) was administered SC by injection BID for 12 weeks.

    Reporting group title
    Relamorelin 30 μg
    Reporting group description
    		 Relamorelin 30 μg was administered SC by injection BID for 12 weeks.

    Reporting group title
    Relamorelin 100 μg
    Reporting group description
    		 Relamorelin 100 μg was administered SC by injection BID for 12 weeks.

    Serious adverse events
    		 Placebo Relamorelin 10 μg Relamorelin 30 μg Relamorelin 100 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 104 (7.69%)
    7 / 98 (7.14%)
    10 / 109 (9.17%)
    6 / 82 (7.32%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnea
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Median nerve injury
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic hematoma
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    2 / 109 (1.83%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hemiparesis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Impaired gastric emptying
         subjects affected / exposed
    2 / 104 (1.92%)
    1 / 98 (1.02%)
    0 / 109 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary tract disorder
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 109 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    1 / 109 (0.92%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 109 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Relamorelin 10 μg Relamorelin 30 μg Relamorelin 100 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 104 (12.50%)
    21 / 98 (21.43%)
    30 / 109 (27.52%)
    28 / 82 (34.15%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 104 (0.96%)
    3 / 98 (3.06%)
    4 / 109 (3.67%)
    6 / 82 (7.32%)
         occurrences all number
    1
    4
    4
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    1 / 109 (0.92%)
    5 / 82 (6.10%)
         occurrences all number
    1
    0
    1
    5
    Headache
         subjects affected / exposed
    3 / 104 (2.88%)
    4 / 98 (4.08%)
    6 / 109 (5.50%)
    2 / 82 (2.44%)
         occurrences all number
    3
    4
    7
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 104 (0.00%)
    4 / 98 (4.08%)
    7 / 109 (6.42%)
    6 / 82 (7.32%)
         occurrences all number
    0
    4
    7
    7
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    7 / 104 (6.73%)
    7 / 98 (7.14%)
    8 / 109 (7.34%)
    6 / 82 (7.32%)
         occurrences all number
    9
    8
    9
    6
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    2 / 104 (1.92%)
    5 / 98 (5.10%)
    10 / 109 (9.17%)
    10 / 82 (12.20%)
         occurrences all number
    2
    6
    11
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2014
    The protocol was updated throughout to add Relamorelin 100 μg treatment arm to confirm the dose range and provide assurance that maximal efficacy has been achieved. Inclusion/exclusion criteria were updated for safety and clarification. Safety monitoring and clinical laboratory assessments were modified for participant safety. Pharmacokinetic time points were added for Day 84 measurements. Participant contacts during the study were detailed and clarified for safety and to encourage compliance with study procedures. Statistical methodology and Schedule of Assessments were updated. Study Procedures by Visit was updated to reflect the changes in procedures and/or timing. Symptom and Global Assessments was updated to present the specific assessments that were to be conducted at Visits 4 and 8, separately.

    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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