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    Clinical Trial Results:
    A double blind placebo controlled study to evaluate the effect of bexagliflozin tablets on hemoglobin A1c in patients with type 2 diabetes mellitus and moderate renal impairment

    Summary
    EudraCT number
    		 2016-002580-34
    Trial protocol
    		 ES  
    Global end of trial date
    11 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2019
    First version publication date
    23 Aug 2019
    Other versions
    Summary report(s)
    		 THR-1442-C-448 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    THR-1442-C-448
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02836873
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EMA: UPI number 498543
    Sponsors
    Sponsor organisation name
    Theracos Sub, LLC
    Sponsor organisation address
    225 Cedar Hill St, Marlborough, MA, United States, 01752
    Public contact
    Clinical Trial Project Management, Translational Medicine Group, 001 5086884221, info@theracos.com
    Scientific contact
    Clinical Trial Project Management, Translational Medicine Group, 001 6176430699, info@theracos.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
    20 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the efficacy of bexagliflozin on lowering HbA1c in patients with type 2 diabetes mellitus and moderate renal impairment.
    Protection of trial subjects
    During the run-in period, subjects received diet and exercise counseling and instructions on contacting the clinic in the event of hypoglycemia, hyperglycemia, or symptoms that may suggest ketoacidosis. Subjects were trained to use the glucometer and record any events in the glycemic control diary. Health status of subjects were reviewed regularly by review of adverse events (AEs), concomitant medications use, vital signs, electrocardiograms (ECGs), and results from physical examinations and blood and urine specimen collections. At every visit, including the phone interviews, participants were queried regarding AEs and information on all events that potentially represent diabetic ketoacidosis (DKA) or major adverse cardiovascular events. Following the exit visit, subjects were advised to see their primary physician to undergo treatment to control their diabetes and cardiovascular conditions. Subjects with hyperglycemia based on blood glucose levels during the treatment period received, at the Investigator's discretion, approved anti-diabetic medication. In addition, adjustment by the investigator to the pre-screening anti-diabetic therapies were recommended if hypoglycemia occurred. Evaluation and management of subjects with and at risk for acute kidney injury (AKI) were performed during the study period based on the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline in 2012.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 116
    Country: Number of subjects enrolled
    United States: 103
    Country: Number of subjects enrolled
    Spain: 65
    Country: Number of subjects enrolled
    France: 28
    Worldwide total number of subjects
    312
    EEA total number of subjects
    93
    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)
    77
    From 65 to 84 years
    232
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment occurred between 23 Sep 2016 and 14 Jun 2017. Subjects were recruited from France, Spain, Japan and the United States.

    Pre-assignment
    Screening details
    		 Screening criteria include male or non-pregnant female ≥ 20 years of age with diagnosis of T2DM with HbA1c between 7.0% and 10.5% and stage 3 CKD (eGFR ≥ 30 and< 60 mL min^-1 per 1.73 m^2. All eligible subjects entered a one week run-in period. Subjects compliant in taking run-in medication and had stable eGFR were eligible for randomization.

    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, Monitor, Carer, Assessor
    Blinding implementation details
    Placebo tablets were produced to match bexagliflozin tablets, 20 mg. Laboratory test urine glucose values were blinded to study team.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bexagliflozin
    Arm description
    		 Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bexagliflozin tablets, 20 mg
    Investigational medicinal product code
    Other name
    EGT0001442, EGT0001474
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet for once daily oral administration

    Arm title
    		 Placebo
    Arm description
    		 Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Inactive tablet to match the active bexagliflozin tablet, 20 mg, for once daily oral administration

    Number of subjects in period 1
    		Bexagliflozin Placebo
    Started
    157
    155
    Completed
    152
    144
    Not completed
    5
    11
         Consent withdrawn by subject
    2
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    4
         Subject moved
    1
    -
         Lost to follow-up
    1
    3
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bexagliflozin
    Reporting group description
    		 Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.

    Reporting group values
    		 Bexagliflozin Placebo Total
    Number of subjects
    		 157 155 312
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.3 ( 8.36 ) 69.9 ( 8.29 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 51 116
        Male
    		 92 104 196
    Race
    Units: Subjects
        White
    		 83 88 171
        Black or African-American
    		 9 6 15
        Asian
    		 61 59 120
        American Indian/Alaskan Native
    		 0 0 0
        Native Hawaiian/Other Pacific Islander
    		 2 0 2
        Other
    		 2 2 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 7 17 24
        Not Hispanic or Latino
    		 149 138 287
        Not Reported
    		 1 0 1
    Country of Investigational Site
    Units: Subjects
        France
    		 12 16 28
        Spain
    		 34 31 65
        Japan
    		 58 58 116
        USA
    		 53 50 103
    SBP
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 135.9 ( 14.25 ) 137.6 ( 14.75 ) -
    HbA1c
    Units: Percent
        arithmetic mean (standard deviation)
    		 8.01 ( 0.786 ) 7.95 ( 0.812 ) -
    FPG
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 8.61 ( 2.525 ) 8.63 ( 2.246 ) -
    eGFR
    Units: mL min-1 per 1.73 m2
        arithmetic mean (standard deviation)
    		 45.44 ( 8.565 ) 44.78 ( 8.085 ) -
    UACR
    Units: mg/g
        arithmetic mean (standard deviation)
    		 355.3 ( 776.77 ) 510.0 ( 1094.46 ) -
    Duration of Diabetes
    Units: Years
        arithmetic mean (standard deviation)
    		 15.54 ( 9.198 ) 16.28 ( 8.977 ) -
    Duration of CKD
    Units: years
        arithmetic mean (standard deviation)
    		 4.92 ( 3.926 ) 5.02 ( 4.99 ) -
    Body Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 82.90 ( 20.509 ) 82.59 ( 21.196 ) -

    End points

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    End points reporting groups
    Reporting group title
    Bexagliflozin
    Reporting group description
    		 Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.

    Primary: Change from Baseline in HbA1c at Week 24

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    End point title
    		 Change from Baseline in HbA1c at Week 24
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Bexagliflozin Placebo
    Number of subjects analysed
    157
    155
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.59 (-0.72 to -0.46)
    -0.31 (-0.44 to -0.18)
    Statistical analysis title
    		 Difference of LS Means from Placebo
    Statistical analysis description
    Model-adjusted using mixed effects repeated measures analysis
    Comparison groups
    Bexagliflozin v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0026
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.1

    Secondary: Change in Body Weight from Baseline to Week 24 in Subjects with BMI >= 25 kg/m2

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    End point title
    		 Change in Body Weight from Baseline to Week 24 in Subjects with BMI >= 25 kg/m2
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Bexagliflozin Placebo
    Number of subjects analysed
    125 [1]
    122 [2]
    Units: kg
        least squares mean (confidence interval 95%)
    -2.31 (-2.84 to -1.79)
    -0.55 (-1.08 to -0.02)
    Notes
    [1] - Subject with BMI >= 25 kg/m2
    [2] - Subject with BMI >= 25 kg/m2
    Statistical analysis title
    		 Difference of LS Means from Placebo
    Comparison groups
    Bexagliflozin v Placebo
    Number of subjects included in analysis
    247
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -1.03

    Secondary: Change in SBP from Baseline to Week 24 in Subject with Baseline SBP >= 130 mm Hg

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    End point title
    		 Change in SBP from Baseline to Week 24 in Subject with Baseline SBP >= 130 mm Hg
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Bexagliflozin Placebo
    Number of subjects analysed
    107 [3]
    113 [4]
    Units: mm Hg
        least squares mean (confidence interval 95%)
    -10.14 (-13.05 to -7.23)
    -7.51 (-10.39 to -4.63)
    Notes
    [3] - Subject with baseline SBP >= 130 mm Hg
    [4] - Subjects with baseline SBP >= 130 mm Hg
    Statistical analysis title
    		 Difference of LS Means from Placebo
    Comparison groups
    Bexagliflozin v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2035
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 1.44

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Bexagliflozin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Bexagliflozin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 157 (7.01%)
    9 / 155 (5.81%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bundle branch block left
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery disease
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis erosive
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathic arthropathy
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Bexagliflozin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    109 / 157 (69.43%)
    105 / 155 (67.74%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    6 / 157 (3.82%)
    3 / 155 (1.94%)
         occurrences all number
    7
    3
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 157 (3.18%)
    3 / 155 (1.94%)
         occurrences all number
    5
    3
    Vascular disorders
    Hypotension
         subjects affected / exposed
    5 / 157 (3.18%)
    3 / 155 (1.94%)
         occurrences all number
    5
    3
    Hypertension
         subjects affected / exposed
    5 / 157 (3.18%)
    0 / 155 (0.00%)
         occurrences all number
    5
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 157 (4.46%)
    11 / 155 (7.10%)
         occurrences all number
    7
    12
    Constipation
         subjects affected / exposed
    3 / 157 (1.91%)
    6 / 155 (3.87%)
         occurrences all number
    3
    6
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    11 / 157 (7.01%)
    4 / 155 (2.58%)
         occurrences all number
    14
    4
    Acute kidney injury
         subjects affected / exposed
    8 / 157 (5.10%)
    6 / 155 (3.87%)
         occurrences all number
    9
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 157 (5.10%)
    5 / 155 (3.23%)
         occurrences all number
    11
    5
    Back pain
         subjects affected / exposed
    5 / 157 (3.18%)
    3 / 155 (1.94%)
         occurrences all number
    5
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 157 (7.01%)
    12 / 155 (7.74%)
         occurrences all number
    12
    18
    Urinary tract infection
         subjects affected / exposed
    9 / 157 (5.73%)
    5 / 155 (3.23%)
         occurrences all number
    10
    5
    Bronchitis
         subjects affected / exposed
    7 / 157 (4.46%)
    2 / 155 (1.29%)
         occurrences all number
    7
    2
    Sinusitis
         subjects affected / exposed
    5 / 157 (3.18%)
    0 / 155 (0.00%)
         occurrences all number
    5
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    39 / 157 (24.84%)
    38 / 155 (24.52%)
         occurrences all number
    239
    249
    Polydipsia
         subjects affected / exposed
    7 / 157 (4.46%)
    2 / 155 (1.29%)
         occurrences all number
    10
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31101403
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