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    Clinical Trial Results:
    A Multicentre, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycaemic Efficacy and Renal Safety of Dapagliflozin in Patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycaemic Control

    Summary
    EudraCT number
    2015-000804-24
    Trial protocol
    SE   IT   ES   CZ   PL  
    Global end of trial date
    07 Nov 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Nov 2018
    First version publication date
    01 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1690C00024
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02413398
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Global Clinical Leader-Dapagliflozin AstraZeneca
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, SE-431 83
    Public contact
    Anna Maria Langkilde, MD PhD, Global Clinical Leader-Dapagliflozin AstraZeneca, +46 31 776 1000, information.center@astrazeneca.com
    Scientific contact
    Anna Maria Langkilde, MD PhD, Global Clinical Leader-Dapagliflozin AstraZeneca, +46 31 776 1000, information.center@astrazeneca.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
    07 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the glycaemic efficacy and renal safety of dapagliflozin (FORXIGA™/FARXIGA™ ) in patients with T2DM and moderate renal impairment (chronic kidney disease stage 3A [CKD 3A]; estimated glomerular filtration rate [eGFR] 45 to 59 mL/min/1.73 m^2) who have inadequate glycaemic control (glycated haemoglobin [HbA1c] ≥7% and ≤11%) under usual care
    Protection of trial subjects
    Two safety adjudication committees were established for this study. An independent Hepatic Adjudication Committee, blinded to the treatment of the patients, determined the probability that drug-induced liver injury (DILI) was the cause of liver-related abnormalities, including, but not limited to: • Hepatic events temporally related to death (within 30 days of death) • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3× upper limit of normal (ULN) and total bilirubin (TB) >2× ULN (within 14 days of the AST and/or ALT elevation • AST and/or ALT >10× ULN All potential events of diabetic ketoacidosis (DKA) were recorded in the electronic case report form (eCRF) and submitted to an independent DKA Adjudication Committee. The DKA Committee Type 2 Diabetes Mellitus (T2DM) assessed available information on each potential DKA event and classified the event in accordance with the definitions in the DKA Adjudication Charter T2DM. The DKA Adjudication Committee was kept blinded to the IP treatment received by each patient with a potential DKA event in the clinical study.
    Background therapy
    For those patients on a background therapy that included insulin, each patient’s baseline insulin therapy should have remained unchanged wherever possible throughout the double blind treatment period. At randomisation, the assignment to either dapagliflozin 10 mg or placebo (1:1) was stratified on background antidiabetic medication.
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Jun 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
    Bulgaria: 53
    Country: Number of subjects enrolled
    Czech Republic: 22
    Country: Number of subjects enrolled
    Italy: 28
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Spain: 46
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Canada: 49
    Country: Number of subjects enrolled
    United States: 91
    Worldwide total number of subjects
    321
    EEA total number of subjects
    181
    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)
    110
    From 65 to 84 years
    211
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 88 study centres (medical facilities) in 8 countries. This included 9 centres in Bulgaria, 17 centres in Canada, 7 centres in Czech Republic, 8 centres in Italy, 7 centres in Poland, 9 centres in Spain, 4 centres in Sweden and 27 centres in the United States (US).

    Pre-assignment
    Screening details
    At enrolment, obtaining written informed consent prior to any study procedure or change in medical therapy was required by the protocol. Consenting patients were assessed to ensure that they met eligibility criteria. Patients who did not meet these criteria were not enrolled in the study.

    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, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dapagliflozin 10mg QD
    Arm description
    10 mg Tablets, Oral, Once daily, 24 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Dapagliflozin 10mg QD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dapagliflozin 10mg QD

    Arm title
    Placebo QD
    Arm description
    Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo QD

    Number of subjects in period 1
    Dapagliflozin 10mg QD Placebo QD
    Started
    160
    161
    Completed
    156
    154
    Not completed
    4
    7
         Other Eligibility criteria
    1
    2
         Consent withdrawn by subject
    1
    1
         Lost to follow-up
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dapagliflozin 10mg QD
    Reporting group description
    10 mg Tablets, Oral, Once daily, 24 weeks

    Reporting group title
    Placebo QD
    Reporting group description
    Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks

    Reporting group values
    Dapagliflozin 10mg QD Placebo QD Total
    Number of subjects
    160 161 321
    Age, Customized
    Units: Subjects
        < 65 Years
    64 46 110
        >= 65 Years
    96 115 211
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    65.3 ± 6.22 66.2 ± 6.49 -
    Sex: Female, Male
    Units: Subjects
        Female
    69 70 139
        Male
    91 91 182
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian Or Alaska Native
    2 0 2
        Asian
    5 8 13
        Black Or African American
    11 12 23
        Other
    1 1 2
        White
    141 140 281
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    32.6 ± 4.7 31.6 ± 5.0 -
    Estimated Glomular Filtration Rate (eGFR)
    Units: mL/min/1.73 m^2
        arithmetic mean (standard deviation)
    51.8 ± 4.1 51.6 ± 3.8 -
    Urine Albumin-to-Creatinine Ratio (UACR)
    Units: mg/g
        arithmetic mean (standard deviation)
    226.91 ± 566.67 246.52 ± 775.49 -

    End points

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    End points reporting groups
    Reporting group title
    Dapagliflozin 10mg QD
    Reporting group description
    10 mg Tablets, Oral, Once daily, 24 weeks

    Reporting group title
    Placebo QD
    Reporting group description
    Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks

    Primary: Adjusted mean change from baseline in HbA1c at Week 24

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    End point title
    Adjusted mean change from baseline in HbA1c at Week 24
    End point description
    To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2).
    End point type
    Primary
    End point timeframe
    At Week 24
    End point values
    Dapagliflozin 10mg QD Placebo QD
    Number of subjects analysed
    157
    159
    Units: percent
        arithmetic mean (standard error)
    -0.37 ± 0.10
    -0.03 ± 0.10
    Statistical analysis title
    MMRM
    Statistical analysis description
    Difference in adjusted mean change from baseline (MMRM model)
    Comparison groups
    Dapagliflozin 10mg QD v Placebo QD
    Number of subjects included in analysis
    316
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.05
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.53
         upper limit
    -0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

    Secondary: Adjusted mean percent change from baseline in total body weight at Week 24.

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    End point title
    Adjusted mean percent change from baseline in total body weight at Week 24.
    End point description
    To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2).
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    Dapagliflozin 10mg QD Placebo QD
    Number of subjects analysed
    159
    161
    Units: percent
    arithmetic mean (standard error)
        Adjusted mean percent change from baseline
    -3.42 ± 0.32
    -2.02 ± 0.32
    Statistical analysis title
    Body weight (%, change from baseline)
    Statistical analysis description
    Difference in adjusted mean percent change from baseline (MMRM)
    Comparison groups
    Dapagliflozin 10mg QD v Placebo QD
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.05
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.15
         upper limit
    -0.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.37

    Secondary: Adjusted mean change from baseline in FPG at Week 24.

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    End point title
    Adjusted mean change from baseline in FPG at Week 24.
    End point description
    To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2)..
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    Dapagliflozin 10mg QD Placebo QD
    Number of subjects analysed
    135
    134
    Units: mg/dL
    arithmetic mean (standard error)
        Change in FPG at Week 24
    -21.4637 ± 5.2053
    -4.8722 ± 5.1267
    Statistical analysis title
    Change in FPG at 24 weeks
    Statistical analysis description
    Difference in adjusted mean change from baseline versus placebo (MMRM)
    Comparison groups
    Dapagliflozin 10mg QD v Placebo QD
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.05
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -16.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -26.73
         upper limit
    -6.46
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.15

    Secondary: Adjusted mean change from baseline in seated SBP at Week 24.

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    End point title
    Adjusted mean change from baseline in seated SBP at Week 24.
    End point description
    To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2).
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    Dapagliflozin 10mg QD Placebo QD
    Number of subjects analysed
    146
    145
    Units: mmHg
    arithmetic mean (standard error)
        Seated SBP (mmHg) change from baseline to Week 24
    -4.8 ± 1.5
    -1.7 ± 1.5
    Statistical analysis title
    SBP change from baseline to Week 24
    Statistical analysis description
    Difference in adjusted mean change from baseline vs. placebo (MMRM)
    Comparison groups
    Dapagliflozin 10mg QD v Placebo QD
    Number of subjects included in analysis
    291
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.05
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.3
         upper limit
    0
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs were collected from the first dose of double-blind treatment through the end of treatment. SAEs were recorded from the time of Informed Consent through the end of the follow-up period.
    Adverse event reporting additional description
    No non-serious AEs met the >5% reporting threshold by Preferred Term.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Dapagliflozin 10mg QD
    Reporting group description
    10 mg Tablets, Oral, Once daily, 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    Matching Placebo, 10 mg Tablets, Oral, Once daily, 24 weeks

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious AEs had an incidence of ≥5%.
    Serious adverse events
    Dapagliflozin 10mg QD Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 160 (5.63%)
    14 / 161 (8.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Small cell lung cancer
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 160 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 160 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         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 / 160 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 160 (0.63%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 160 (0.63%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 160 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gingival bleeding
         subjects affected / exposed
    1 / 160 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired hydrocele
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         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
    Joint swelling
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 160 (0.63%)
    0 / 161 (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
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 160 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diabetic gangrene
         subjects affected / exposed
    1 / 160 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 161 (0.62%)
         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
    Dapagliflozin 10mg QD Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 160 (0.00%)
    0 / 161 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jan 2016
    The number of sites was updated. Updated the benefit/risk and ethical assessment section of CSP to include the potential risk of DKA. The upper limit of BMI range was increased to 45 kg/m^2. Exclusion criterion #37 and text related to restrictions on metformin in CSP Section 7.7 were modified by including “or” to allow a difference between Investigator’s judgment and local guidelines. Exclusion criterion #38 was updated to explicitly state that ongoing treatment with GLP-1 agonist was an exclusion criterion. The sample specimen has been corrected to state “blood glucose” instead of “fasting plasma glucose.”
    01 Apr 2016
    Inclusion/Exclusion criteria were updated: 1. HbA1c was removed from Visit 3 and the eGFR criterion modified. 2. Exclusion criterion #24 was introduced 3. Exclusion criterion #47 (48, in the current version) was modified. Blood volume was updated (reduced by 2 mL to 61 mL).
    17 Jan 2017
    Exclusion criteria #39 was included to provide clarity that rapid or short acting insulin were never allowed in the study from the version 1.0 of the CSP. New CSP Section 5.2.5.6 was added to include information about the reporting and adjudication of DKA events in the study.

    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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