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    Clinical Trial Results:
    SOdium-glucose CO-transporter inhibition in patients with newly detected Glucose Abnormalities post Myocardial Infarction (SOCOGAMI)

    Summary
    EudraCT number
    		 2015-004571-73
    Trial protocol
    		 SE  
    Global end of trial date
    25 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2023
    First version publication date
    27 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SOCOGAMI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    Nobels väg 6, Stockholm, Sweden, 17177
    Public contact
    Lars Rydén, Karolinska Institutet Department of Medicine Solna, Cardiology Unit, +46 8-517 721 71, lars.ryden@ki.se
    Scientific contact
    Lars Rydén, Karolinska Institutet Department of Medicine Solna, Cardiology Unit, +46 8-517 721 71, lars.ryden@ki.se
    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
    01 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test the hypotheses that Empagliflozin (Jardiance®) will have a beneficial effect on myocardial function and structure, glucose homeostasis and beta cell function in patients with recent myocardial infarction or unstable angina pectoris and newly detected impaired glucose tolerance or type 2 diabetes.
    Protection of trial subjects
    All patients signed consent to study participation following written and oral information. The trial was carried out in compliance with principles in the Declaration of Helsinki, 1996 version, in accordance with the ICH Harmonized Tripartite Guideline for Good Clinical Practice (GCP) and in accordance with applicable regulatory requirements. The protocol was approved by the Regional Ethics committee in Stockholm (Dnr 2015:4/11).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jun 2016
    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: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    11
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients aged > 18 years, who during the previous six months suffered AMI or unstable angina pectoris were recruited. 55 patients were screened, 13 didn't meet the inclusion criterias, and 42 patients were included.

    Pre-assignment
    Screening details
    		 Inclusion criteria: patients aged >18 years, who during the previous six months suffered AMI or unstable angina pectoris were recruited if they, had newly detected IGT or T2DM confirmed by two screening oral glucose tolerance tests (OGTT). Exclusion criteria: known diabetes, contraindications to CMR imaging, eGFR < 30 ml/min/1.73 m2; and more.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Patients in placebo arm were randomized to 25 mg of corresponding placebo. They received a patient diary, equipment for and instruction on self-monitoring of glucose levels and were seen at the outpatient clinic one and three months later. Seven months after randomization all investigations performed during the baseline visit were repeated. Thereafter the study drug was discharged. Ten months after randomization the patient returned for a final visit, during which all investigations were repeated once more.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients in placebo arm were randomized to 25 mg of placebo daily. After 7 months the study drug was discharged.

    Arm title
    		 Empagliflozin
    Arm description
    		 Patients in Empagliflozin arm were randomized to 25 mg Empagliflozin daily. They received a patient diary, equipment for and instruction on self-monitoring of glucose levels and were seen at the outpatient clinic one and three months later. Seven months after randomization all investigations performed during the baseline visit were repeated. Thereafter the study drug was discharged. Ten months after randomization the patient returned for a final visit, during which all investigations were repeated once more.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Empagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients in Empagliflozin arm were randomized to 25 mg of Empagliflozin daily. After 7 months the study drug was discharged.

    Number of subjects in period 1
    		Placebo Empagliflozin
    Started
    22
    20
    Completed
    22
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients in placebo arm were randomized to 25 mg of corresponding placebo. They received a patient diary, equipment for and instruction on self-monitoring of glucose levels and were seen at the outpatient clinic one and three months later. Seven months after randomization all investigations performed during the baseline visit were repeated. Thereafter the study drug was discharged. Ten months after randomization the patient returned for a final visit, during which all investigations were repeated once more.

    Reporting group title
    Empagliflozin
    Reporting group description
    		 Patients in Empagliflozin arm were randomized to 25 mg Empagliflozin daily. They received a patient diary, equipment for and instruction on self-monitoring of glucose levels and were seen at the outpatient clinic one and three months later. Seven months after randomization all investigations performed during the baseline visit were repeated. Thereafter the study drug was discharged. Ten months after randomization the patient returned for a final visit, during which all investigations were repeated once more.

    Reporting group values
    		 Placebo Empagliflozin Total
    Number of subjects
    		 22 20 42
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68 ( 8 ) 67 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4 8
        Male
    		 18 16 34
    Smoking
    Units: Subjects
        Yes
    		 19 19 38
        No
    		 3 1 4
    Index event
    Units: Subjects
        Myocardial infarction
    		 19 17 36
        Unstable angina
    		 3 3 6
    Peripheral artery disease
    Medical history
    Units: Subjects
        Yes
    		 0 1 1
        No
    		 22 19 41
    Stroke/TIA
    Medical history. TIA = transitory ischaemic attack
    Units: Subjects
        Yes
    		 0 2 2
        No
    		 22 18 40
    Heart failure
    Medical history
    Units: Subjects
        Yes
    		 0 1 1
        No
    		 22 19 41
    ACE-inhibitors/ARBs
    Pharmacological treatment. ACE = angiotensin converting enzyme; ARB = angiotensin receptor blocker
    Units: Subjects
        Yes
    		 18 17 35
        No
    		 4 3 7
    Beta-blockers
    Pharmacological treatment
    Units: Subjects
        Yes
    		 21 17 38
        No
    		 1 3 4
    Calcium channel blockers
    Pharmacological treatment
    Units: Subjects
        Yes
    		 4 5 9
        No
    		 18 15 33
    Diuretics
    Pharmacological treatment
    Units: Subjects
        Yes
    		 3 7 10
        No
    		 19 13 32
    Statins
    Pharmacological treatment
    Units: Subjects
        Yes
    		 21 20 41
        No
    		 1 0 1
    Antiaggregants
    Pharmacological treatment
    Units: Subjects
        Yes
    		 16 19 35
        No
    		 6 1 7
    Anticoagulants
    Pharmacological treatment
    Units: Subjects
        Yes
    		 2 0 2
        No
    		 20 20 40
    Body mass index
    Units: (kg/m2)
        arithmetic mean (standard deviation)
    		 27 ( 4 ) 27 ( 4 ) -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 131 ( 16 ) 130 ( 16 ) -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 80 ( 10 ) 79 ( 10 ) -
    Heart rate
    Units: beats/minute
        arithmetic mean (standard deviation)
    		 68 ( 8 ) 62 ( 7 ) -
    Haemoglobin
    Laboratory findings
    Units: g/L
        arithmetic mean (standard deviation)
    		 140 ( 10 ) 142 ( 19 ) -
    LDL-cholesterol
    Laboratory findings. LDL = low-density lipoprotein
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 1.4 ( 0.6 ) 1.4 ( 0.3 ) -
    Triglycerides
    Laboratory findings
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 3.3 ( 9.3 ) 1.3 ( 0.6 ) -
    Creatinine
    Laboratory findings
    Units: μmol/L
        arithmetic mean (standard deviation)
    		 81 ( 18 ) 86 ( 16 ) -
    eGFR
    Laboratory findings. eGFR = estimated glomerular filtration
    Units: ml/min/1.73 m2
        arithmetic mean (standard deviation)
    		 73 ( 14 ) 68 ( 13 ) -
    Troponin
    Laboratory findings
    Units: ng/L
        arithmetic mean (standard deviation)
    		 16 ( 12 ) 15 ( 14 ) -
    hsCRP
    Laboratory findings. hsCRP = high-sensitivity C-reactive protein
    Units: mg/L
        arithmetic mean (standard deviation)
    		 1.7 ( 2.4 ) 1.2 ( 0.8 ) -
    NT-pro-BNP
    Laboratory findings. BNP = brain natriuretic peptide
    Units: ng/L
        arithmetic mean (standard deviation)
    		 249 ( 305 ) 361 ( 406 ) -
    Fasting plasma glucose
    Laboratory findings
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 6.5 ( 1.1 ) 6.5 ( 0.9 ) -
    2-hour post load glucose
    Laboratory findings
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 10.6 ( 2.9 ) 10.9 ( 2.9 ) -
    HbA1c
    Laboratory findings. HbA1c = glycated haemoglobin A1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 43 ( 9 ) 42 ( 6 ) -
    LV end-diastolic volume
    Units: ml
        median (standard deviation)
    		 141 ( 39 ) 146 ( 33 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients in placebo arm were randomized to 25 mg of corresponding placebo. They received a patient diary, equipment for and instruction on self-monitoring of glucose levels and were seen at the outpatient clinic one and three months later. Seven months after randomization all investigations performed during the baseline visit were repeated. Thereafter the study drug was discharged. Ten months after randomization the patient returned for a final visit, during which all investigations were repeated once more.

    Reporting group title
    Empagliflozin
    Reporting group description
    		 Patients in Empagliflozin arm were randomized to 25 mg Empagliflozin daily. They received a patient diary, equipment for and instruction on self-monitoring of glucose levels and were seen at the outpatient clinic one and three months later. Seven months after randomization all investigations performed during the baseline visit were repeated. Thereafter the study drug was discharged. Ten months after randomization the patient returned for a final visit, during which all investigations were repeated once more.

    Primary: LV end-diastolic volume

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    End point title
    		 LV end-diastolic volume
    End point description
    The LV end-diastolic volume from at seven months measured by CMR.
    End point type
    Primary
    End point timeframe
    At seven months.
    End point values
    		 Placebo Empagliflozin
    Number of subjects analysed
    22
    20
    Units: ml
        arithmetic mean (standard deviation)
    143 ( 39 )
    145 ( 41 )
    Statistical analysis title
    		 Change in the LV end-diastolic volume
    Statistical analysis description
    Change in the LV end-diastolic volume from baseline to seven months measured by CMR
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At each study visit i.e. after 7 months on randomized treatment and 3 months after study drug cessation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 n/a
    Dictionary version
    n/a
    Reporting groups
    Reporting group title
    Overall group
    Reporting group description
    		 -

    Serious adverse events
    		 Overall group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 42 (21.43%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Chest pain
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Fungal infection vaginal
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1

    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.
    A weakness may be the limited number of patients, but it is unlikely that the inclusion of further study participants of the same kind would have changed the results.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36336088
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