Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    The Effect of a SGLT2 inhibitor on Glucose flux, Lipolysis and Exercise in type 2 Diabetes

    Summary
    EudraCT number
    		 2016-004878-17
    Trial protocol
    		 GB  
    Global end of trial date
    08 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2021
    First version publication date
    15 May 2021
    Other versions
    Summary report(s)
    		 Abstract

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    0585
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04219124
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leicester
    Sponsor organisation address
    Research Governance Office, Academic Department, Leicester General Hospital, Leicester, United Kingdom, LE5 4PW
    Public contact
    Roselle Herring, Royal Surrey County Hospital, +44 (0) 7777621085, roselle.herring@nhs.net
    Scientific contact
    Roselle Herring, Royal Surrey County Hospital, +44 (0) 7777621085, roselle.herring@nhs.net
    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
    Interim
    Date of interim/final analysis
    26 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the differences in mean concentration of 3-hydroxybutyrate between 420-480 mins and the AUC of 3-hydroxybutyrate concentration time curve between 0-240 mins and 0-480 mins following 4 week treatment with dapagliflozin compared to placebo in Visit 4 and visit 6 where the IMP was given at 0 mins.
    Protection of trial subjects
    This was not an efficacy study. All safety assessments were standard. The study personnel were all trained on managing safety information according to agreed procedures. During the study adverse events were collected and documented at every visit, regardless of relationship to study medication. these events were coded using MedDRA (medical Dictionary for Regulatory Activities) dictionary version 18.1 September 2015 checked by the study physician. The following criteria were used to identify adverse events: Any unfavourable or unintended sign or symptom Any deterioration in laboratory data, vital signs or found on physical examination All concomitant medications taken during the study were recorded.
    Background therapy
    		 Allowable concomitant diabetes therapy: Metformin
    Evidence for comparator
    		 The type of control group: as it was a cross-over trial the participants acted as their own controls. The placebo and Dapagliflozin tablets were indistinguishable and provided in similar containers. Rationale behind design: A randomised double-blind placebo controlled study design was chosen to study the effect of dapagliflozin against a placebo treatment where both the participant and the research group were blinded to the order of the treatment received. Known or potential problems with design or control groups chosen in relation to the study: Using a cross-over trial can mean that a carry-over effect occurs from the first period to the second period of the trial. This was minimised by using a double blinded approach and by the presence of a four-week washout period between the treatment arms. Statistical analyses were conducted to determine whether a period effect was present. In this eventuality, comparisons between treatments were made solely at datta from period one.
    Actual start date of recruitment
    20 Sep 2018
    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
    United Kingdom: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    6
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 recruitment: From Diabetes Clinics at Cedar centre, Royal Surrey County Hospital and additional locations: local GP practices, other healthcare settings including but not limited to outpatient clinics, retinal screening, podiatry, diabetes patient groups, University of Surrey staff. Recruitment was between September 2018 and January 2020.

    Pre-assignment
    Screening details
    		 There were no washout or pre assignment periods for screening. Interested patients with type 2 diabetes inadequately controlled by metformin were interviewed on the phone to confirm the inclusion criteria, 13 patients were recruited 4 patients were withdrawn.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    This is a double blind cross study. Subjects were randomised into 2 groups. One group received a once daily oral tablet of dapagliflozin for 4 weeks followed by a 4 week washout then once daily oral tablet of placebo for 4 weeks. The other group received a once daily oral tablet of placebo for 4 weeks followed by a 4 week washout then once daily oral intake of tablet of dapagliflozin for 4 week. the placebo and dapagliflozin tablets were indistinguishable.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Dapagliflozin
    Arm description
    		 Dapagliflozin or placebo are considered as investigational medical product (IMP). Metformin is not considered an investigational product but is an allowed antidiabetic medication to be taken concomitantly. Investigational product: Dapagliflozin 10 mg Dosage form and strength: Green, plain, diamond shaped, film coated 10 mg tablet Manufacturer: AstraZeneca Ltd Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.
    Arm type
    		 cross over

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    461432-26-8, Cayman Chemical
    Other name
    Farxiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals. Used once daily

    Investigational medicinal product name
    Comparator to Dapagliflozin
    Investigational medicinal product code
    PL1
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.

    Arm title
    		 placebo
    Arm description
    		 Dapagliflozin and placebo are considered as investigational medicinal product (IMP). Metformon is not considered an investigational medicinal product. Investigational product: Dapagliflozin 10 mg Dosage form and strength: Green, plain, diamond shaped, film coated 10 mg tablet Manufacturer: AstraZeneca Ltd Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.
    Arm type
    		 cross over

    Investigational medicinal product name
    Comparator to Dapagliflozin
    Investigational medicinal product code
    PL1
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Investigational product: Dapagliflozin 10 mg Dosage form and strength: Green, plain, diamond shaped, film coated 10 mg tablet Manufacturer: AstraZeneca Ltd Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals. Used once daily

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    461432-26-8, Cayman Chemical
    Other name
    Farxiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Investigational product: Dapagliflozin 10 mg Dosage form and strength: Green, plain, diamond shaped, film coated 10 mg tablet Manufacturer: AstraZeneca Ltd Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.

    Number of subjects in period 1
    		Dapagliflozin placebo
    Started
    9
    9
    Completed
    9
    9

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups [1]
    Reporting group title
    Overall period
    Reporting group description
    		 Participants with type 2 diabetes completed both arm of the trial in the cross over study. Four participants were withdrawn from from the study, two participants while receiving dapagliflozin and two participants while receiving placebo.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Justification- Baseline characteristics reported here are for those participants who completed the study that is n=9.
    Reporting group values
    		 Overall period Total
    Number of subjects
    		 9 9
    Age categorical
    Overall- The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same. Baseline characteristics reported here are for those participants who completed the study n=9.
    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)
    		 3 3
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.7 ( 11.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 6 6
    BMI
    Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 28.9 ( 2.9 ) -
    HbA1c
    HeamoglobulinA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 60.2 ( 7.6 ) -
    SBP
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 136.3 ( 11.8 ) -
    DBP
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 81.7 ( 10.7 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Dapagliflozin
    Reporting group description
    		 Dapagliflozin or placebo are considered as investigational medical product (IMP). Metformin is not considered an investigational product but is an allowed antidiabetic medication to be taken concomitantly. Investigational product: Dapagliflozin 10 mg Dosage form and strength: Green, plain, diamond shaped, film coated 10 mg tablet Manufacturer: AstraZeneca Ltd Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.

    Reporting group title
    placebo
    Reporting group description
    		 Dapagliflozin and placebo are considered as investigational medicinal product (IMP). Metformon is not considered an investigational medicinal product. Investigational product: Dapagliflozin 10 mg Dosage form and strength: Green, plain, diamond shaped, film coated 10 mg tablet Manufacturer: AstraZeneca Ltd Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.

    Primary: Plasma concentration of 3-hydroxybutyrate Mean (420-480 min)

    		 Close Top of page
    End point title
    		 Plasma concentration of 3-hydroxybutyrate Mean (420-480 min)
    End point description
    Mean plasma concentration of 3-hydroxybutyrate measured at (420-480 min) following 4 weeks treatment with either dapagliflozin or Placebo (Visit 4 or Visit 6, depending on the randomisation) dapagliflozin was administered at 0 min.
    End point type
    Primary
    End point timeframe
    4 week once daily oral intake of dapagliflozin or Placebo tablets, blood samples obtained at 4 weeks (Visit 4 or Visit 6).
    End point values
    		 Dapagliflozin placebo
    Number of subjects analysed
    9
    9
    Units: mmol/L
        arithmetic mean (standard deviation)
    0.39 ( 0.08 )
    0.15 ( 0.04 )
    Attachments
    		 BOHB concentration after a fat meal at 0min.
    Statistical analysis title
    		 Superiority testing
    Statistical analysis description
    This was a double blind cross-over study. BOHB concentration mean value for 420-480min was statistically analysed as the response variable in a general linear mixed model (using PROC Mixed procedure in SAS software), with treatment, period, treatment by period interaction, as fixed effects, and the baseline BOHB concentration as a covariate. The subject will be the random effects in the model. The denominator degrees of freedom will be adjusted using Kenward-Roger approximations.
    Comparison groups
    Dapagliflozin v placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.015 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.234
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.052
         upper limit
    		 0.415
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.084
    Notes
    [1] - This was a double blind cross-over study. BOHB concentration mean value for 420-480min was statistically analysed as the response variable in a general linear mixed model (using PROC Mixed procedure in SAS software), with treatment, period, treatment by period interaction, as fixed effects, and the baseline BOHB concentration as a covariate. The subject will be the random effects in the model. The denominator degrees of freedom will be adjusted using Kenward-Roger approximations.
    [2] - significant at p <0.05

    Primary: the AUC of 3-hydroxybutyrate concentration time curve between 0-240 mins

    		 Close Top of page
    End point title
    		 the AUC of 3-hydroxybutyrate concentration time curve between 0-240 mins
    End point description
    Area under the curve for 3-hydroxybutyrate concentration (mmol/L *min) for period 0-240 mins, after an intake of 30 ml of olive oil containing 200 mg U labelled 13C Palmitic acid at 0 min, at the end of 4 weeks treatment with either dapagliflozin or placebo (visits V4 or V6, depending on randomisation). Dapagliflozin or Placebo was was taken orally at 0 min.
    End point type
    Primary
    End point timeframe
    4 week once daily oral in take of dapagliflozin or placebo, blood samples obtained at 4 weeks
    End point values
    		 Dapagliflozin placebo
    Number of subjects analysed
    9
    9
    Units: mmol/L *min
        arithmetic mean (standard error)
    41.1 ( 7.8 )
    23.5 ( 3.8 )
    Statistical analysis title
    		 Superiority testing
    Statistical analysis description
    This was a double blind cross-over study. BOHB concentration AUC 0-240 min was statistically analysed as the response variable in a general linear mixed model (using PROC Mixed procedure in SAS software), with treatment, period, treatment by period interaction, as fixed effects, and the baseline BOHB concentration as a covariate. The subject will be the random effects in the model. The denominator degrees of freedom will be adjusted using Kenward-Roger approximations.
    Comparison groups
    Dapagliflozin v placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.081 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.518
         upper limit
    		 36.003
    Variability estimate
    Standard error of the mean
    Notes
    [3] - This was a double blind cross-over study. BOHB concentration AUC 0-240 min was statistically analysed as the response variable in a general linear mixed model (using PROC Mixed procedure in SAS software), with treatment, period, treatment by period interaction, as fixed effects, and the baseline BOHB concentration as a covariate. The subject will be the random effects in the model. The denominator degrees of freedom will be adjusted using Kenward-Roger approximations.
    [4] - not significant

    Primary: Plasma concentration of 3-hydroxybutyrate AUC(0-480 min)

    		 Close Top of page
    End point title
    		 Plasma concentration of 3-hydroxybutyrate AUC(0-480 min)
    End point description
    Area under the curve for 3-hydroxybutyrate concentration (mmol/L *min) for period 0-480 mins, after an intake of 30 ml of olive oil containing 200 mg U labelled 13C Palmitic acid at 0 min, at the end of 4 weeks treatment with either dapagliflozin or placebo (visits V4 or V6, depending on randomisation). Dapagliflozin or Placebo was was taken orally at 0 min.
    End point type
    Primary
    End point timeframe
    4 week once daily oral intake of dapagliflozin or Placebo tablets, blood samples obtained at 4 weeks (Visit 4 or Visit 6).
    End point values
    		 Dapagliflozin placebo
    Number of subjects analysed
    9
    9
    Units: mmol/L *min
        arithmetic mean (standard error)
    116.4 ( 17.7 )
    56.6 ( 8.9 )
    Statistical analysis title
    		 Superiority testing
    Statistical analysis description
    This was a double blind cross-over study. BOHB concentration AUC 0-480 min was statistically analysed as the response variable in a general linear mixed model (using PROC Mixed procedure in SAS software), with treatment, period, treatment by period interaction, as fixed effects, and the baseline BOHB concentration as a covariate. The subject will be the random effects in the model. The denominator degrees of freedom will be adjusted using Kenward-Roger approximations.
    Comparison groups
    Dapagliflozin v placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.012 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    57.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.95
         upper limit
    		 100.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    19.92
    Notes
    [5] - This was a double blind cross-over study. BOHB concentration AUC 0-480 min was statistically analysed as the response variable in a general linear mixed model (using PROC Mixed procedure in SAS software), with treatment, period, treatment by period interaction, as fixed effects, and the baseline BOHB concentration as a covariate. The subject will be the random effects in the model. The denominator degrees of freedom will be adjusted using Kenward-Roger approximations.
    [6] - Significant at p<0.05

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    This includes events from the first trial activity after the subject has signed the informed consent and until post treatment follow
    Adverse event reporting additional description
    The following criteria were used to identify adverse events: Any unfavourable or unintended sign or symptom, any deterioration in laboratory data, vital signs or found physical examination. All concomitant medications taken during the study were recorded.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Dapaglifolozin
    Reporting group description
    		 Investigational product: Dapagliflozin 10 mg Dosage form and strength: Green, plain, diamond shaped, film coated 10 mg tablet Manufacturer: AstraZeneca Ltd Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.

    Reporting group title
    placebo
    Reporting group description
    		 Investigational product: Dapagliflozin 10 mg Dosage form and strength: Green, plain, diamond shaped, film coated 10 mg tablet Manufacturer: AstraZeneca Ltd Investigational product: Matching placebo for Dapagliflozin 10 mg. Dosage form and strength: Green, plain, diamond shaped, and film coated tablet Dapagliflozin and its matching placebo will be supplied in bottles. The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.

    Serious adverse events
    		 Dapaglifolozin placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 12 (16.67%)
         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)
    Neoplasm
    Additional description: New diagnosis of Glioma
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Infection
    Additional description: Developed skin infection that required hospital admission
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dapaglifolozin placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 11 (54.55%)
    8 / 12 (66.67%)
    Injury, poisoning and procedural complications
    Drug dispensed to wrong patient
    Additional description: Patient received wrong IMP for 2 days. Removed from trial
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Cardiac disorders
    Hypotension
    Additional description: Postural
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    Headache
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Immune system disorders
    Allergy test positive
    Additional description: Skin reaction
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Eye disorders
    Photophobia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Crohn's flare
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Colonoscopy
    Additional description: benign polyps
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Balanitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Renal colic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Sciatica
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2017
    1- Change of site for Final QP release and randomisation 2- updating of the protocol to reflect the source data will be entered into workbooks and then entered into CRFs.
    19 Dec 2017
    - Change of isotope and definition of primary and secondary end point - due to the National shortage of IV palmidornate the study methodology had to be changed. This has resulted in a change in the statistical analysis.
    01 Jun 2018
    Notification to MHRA and HRA- We have been informed Renascience, the company which was providing the randomised, paired, kit numbers bottles containing 28 tablets of either placebo or active and shipping to Royal Surrey County Hospital research pharmacy for dispensing is restructuring. Renascience clinical trials service was also organising the randomisation and proving emergency randomisation codes. As a result of restructuring, Renaclinical Ltd has been created, MHRA authorisations held by Renascience have been realigned via a change of ownership process. MIA (IMP) 44696 has been transferred to Renaclinical as MIA(IMP)49160.
    31 Oct 2018
    1- Owing to difficulties in recruitment we would like to broaden our recruitment to allow us to approach patients in additional locations. 2- requesting permission to analyse blood taken during the metabolic study day for additional biomarkers of heart failure. 3- Extension of the study to 31/08/2019 as the green light was only received in August 2018.
    25 Sep 2019
    Extension of the study until 31/04/2020. owing to early recruitment difficulties and 4 people withdrawn from the study, some patients have been enrolled late and will be unable to complete the second arm of the study until December 2019. This will not incur any additional cost but means the lab analysis is delayed until early next year.

    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.
    1- Urinary ketone excretion was not measured. 2- We were unable to recruit the whole quota for the patient group. This may have an impact on the level of significance on the metabolomics findings carried out on visit 4 and V6.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 19 03:39:24 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA