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    Clinical Trial Results:
    A 24 Week, Phase IIa, Double blind, Randomized, Parallel Group, Placebo-controlled, Proof of Concept Study to Assess the Efficacy and Safety of Two Doses of 5 Aminolevulinic Acid Co-administered with Sodium Ferrous Citrate in Adult Patients with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2017-004944-39
    Trial protocol
    		 EE   HU   PL   RO  
    Global end of trial date
    17 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2021
    First version publication date
    04 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NPJ005-DM2-0522
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    neopharma Japan
    Sponsor organisation address
    2nd Floor, PMO Kojimachi, Kojimachi 6-2-6, Chiyoda-ku, Tokyo, Japan, 102-0083
    Public contact
    Clinical Trial Information Desk, neopharma Japan Co., Ltd., npjprd@neopharmajp.com
    Scientific contact
    Clinical Trial Information Desk, neopharma Japan Co., Ltd., npjprd@neopharmajp.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
    16 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the change from Baseline in Glycated hemoglobin (HbA1c) up to Week 24 between each dose combination of 5 aminolevulinic acid/sodium ferrous citrate (5 ALA/SFC) and placebo.
    Protection of trial subjects
    Patients were enrolled in the study only after providing informed consent, and undergoing inclusion and exclusion assessments. Rescue therapy for patients in either treatment arm with prandial insulin or oral antidiabetic (OAD) therapy was offered per Investigator’s discretion and in consultation with Medical Monitor from randomization until end of the study, depending on fasting blood glucose values.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Apr 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
    Poland: 43
    Country: Number of subjects enrolled
    Estonia: 42
    Country: Number of subjects enrolled
    Hungary: 41
    Country: Number of subjects enrolled
    Romania: 46
    Country: Number of subjects enrolled
    Ukraine: 46
    Worldwide total number of subjects
    218
    EEA total number of subjects
    172
    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)
    130
    From 65 to 84 years
    88
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 218 patients were enrolled at 74 sites in Hungary, Poland, Estonia, Romania and Ukraine from 31-May-2018 to 17-Feb-2020.

    Pre-assignment
    Screening details
    		 434 potential patients underwent a screening period of maximally 2 weeks. Eligible patients enrolled with current OAD monotherapy underwent a 4-week Washout period followed by a 2-week single-blinded Placebo run-in period before entering the 24-week Treatment period.

    Period 1
    Period 1 title
    Treatment period (24 weeks) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject
    Blinding implementation details
    The appearance, including packaging and labeling of the study treatment (capsules, packaging) was the same for 5-ALA/SFC and the placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5-ALA-HCl 150 mg/SFC 118 mg
    Arm description
    		 The patients received 5-ALA/SFC at a dose of 150 mg/118 mg (1 capsule each BID), for a total daily dose of 300 mg/236 mg for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    5-aminolevulinic acid hydrochloride/sodium ferrous citrate (5-ALA-HCl/SFC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5-ALA/SFC was administered orally at a dose of 150 mg/119 mg (1 capsule each BID), for a total daily dose of 300 mg/236 mg at least 8 hours apart in the morning and evening, after the meal, for 24 weeks.

    Arm title
    		 5-ALA-HCl 50 mg/SFC 39 mg
    Arm description
    		 The patients received 5-ALA/SFC at a dose of 50 mg/39 mg (1 capsule each BID), for a total daily dose of 100 mg/78 mg for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    5-aminolevulinic acid hydrochloride/sodium ferrous citrate (5-ALA-HCl/SFC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5-ALA/SFC was administered orally at a dose of 50 mg/39 mg (1 capsule each BID), for a total daily dose of 100 mg/78 mg at least 8 hours apart in the morning and evening, after the meal, for 24 weeks.

    Arm title
    		 Placebo
    Arm description
    		 The patients received an equal number of matching placebo capsules (BID) for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo capsules were administered in the same manner as the test product.

    Number of subjects in period 1
    		5-ALA-HCl 150 mg/SFC 118 mg 5-ALA-HCl 50 mg/SFC 39 mg Placebo
    Started
    72
    73
    73
    Completed
    63
    56
    60
    Not completed
    9
    17
    13
         Consent withdrawn by subject
    2
    4
    3
         Adverse event, non-fatal
    2
    4
    2
         Other
    -
    -
    1
         Rescue Criteria Met
    4
    8
    6
         Use of Prohibited Medication
    1
    1
    -
         Noncompliance with protocol
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    5-ALA-HCl 150 mg/SFC 118 mg
    Reporting group description
    		 The patients received 5-ALA/SFC at a dose of 150 mg/118 mg (1 capsule each BID), for a total daily dose of 300 mg/236 mg for 24 weeks.

    Reporting group title
    5-ALA-HCl 50 mg/SFC 39 mg
    Reporting group description
    		 The patients received 5-ALA/SFC at a dose of 50 mg/39 mg (1 capsule each BID), for a total daily dose of 100 mg/78 mg for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 The patients received an equal number of matching placebo capsules (BID) for 24 weeks.

    Reporting group values
    		 5-ALA-HCl 150 mg/SFC 118 mg 5-ALA-HCl 50 mg/SFC 39 mg Placebo Total
    Number of subjects
    		 72 73 73 218
    Age categorical
    Units: Subjects
        < 65 years
    		 42 43 45 130
        ≥ 65 years
    		 30 30 28 88
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.2 ± 9.48 61.6 ± 8.16 59.4 ± 9.53 -
    Gender categorical
    Units: Subjects
        Female
    		 41 39 40 120
        Male
    		 31 34 33 98
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 72 73 73 218
    Race
    Units: Subjects
        White
    		 72 73 73 218
    Oral antidiabetic mono therapy
    Units: Subjects
        Yes
    		 45 46 46 137
        No
    		 27 27 27 81
    Treatment-Free Status
    Units: Subjects
        Yes
    		 27 27 27 81
        No
    		 45 46 46 137
    Complication related T2DM
    Units: Subjects
        Yes
    		 8 8 7 23
        No
    		 64 65 66 195
    HbA1c
    Units: Subjects
        < 8%
    		 55 57 54 166
        ≥ 8%
    		 17 16 19 52
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 167.17 ± 9.264 168.46 ± 8.947 168.67 ± 9.293 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 91.74 ± 14.894 91.50 ± 16.602 94.07 ± 15.477 -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 32.76 ± 4.102 32.10 ± 4.283 32.96 ± 4.057 -
    Waist Circumference
    Units: cm
        arithmetic mean (standard deviation)
    		 107.7 ± 13.04 107.6 ± 12.85 108.4 ± 11.61 -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 133.0 ± 10.32 131.8 ± 13.47 133.7 ± 11.22 -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 78.0 ± 7.01 78.3 ± 8.42 79.2 ± 7.89 -
    HbA1c
    Units: percent
        arithmetic mean (standard deviation)
    		 7.34 ± 0.698 7.37 ± 0.875 7.49 ± 0.757 -
    Duration of T2DM
    Units: years
        arithmetic mean (standard deviation)
    		 4.94 ± 4.695 6.21 ± 5.051 6.83 ± 5.717 -
    Fasting C-peptide
    Units: nmol/L
        arithmetic mean (standard deviation)
    		 1.045 ± 0.5062 0.968 ± 0.4234 0.920 ± 0.3573 -
    Fasting Plasma Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 8.70 ± 1.996 8.90 ± 2.200 9.18 ± 1.989 -
    eGFR
    Units: ml/min/1.73m2
        arithmetic mean (standard deviation)
    		 94.71 ± 22.552 91.87 ± 20.969 94.21 ± 20.061 -
    Serum Zinc
    The threshold of serum zinc ≥ lower level was 9.2 μmol/L (range: 9.2 to 19.9 μmol/L)
    Units: μg/dL
        arithmetic mean (standard deviation)
    		 15.29 ± 3.678 14.74 ± 4.360 14.10 ± 2.957 -
    CGM
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 116.7 ± 70.92 126.4 ± 71.93 113.8 ± 68.62 -

    End points

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    End points reporting groups
    Reporting group title
    5-ALA-HCl 150 mg/SFC 118 mg
    Reporting group description
    		 The patients received 5-ALA/SFC at a dose of 150 mg/118 mg (1 capsule each BID), for a total daily dose of 300 mg/236 mg for 24 weeks.

    Reporting group title
    5-ALA-HCl 50 mg/SFC 39 mg
    Reporting group description
    		 The patients received 5-ALA/SFC at a dose of 50 mg/39 mg (1 capsule each BID), for a total daily dose of 100 mg/78 mg for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 The patients received an equal number of matching placebo capsules (BID) for 24 weeks.

    Primary: Change from baseline in HbA1c to Week 24

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    End point title
    		 Change from baseline in HbA1c to Week 24
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Week 24
    End point values
    		 5-ALA-HCl 150 mg/SFC 118 mg 5-ALA-HCl 50 mg/SFC 39 mg Placebo
    Number of subjects analysed
    72
    71
    70
    Units: percent
        least squares mean (standard error)
    -0.27 ± 0.076
    -0.01 ± 0.080
    0.00 ± 0.078
    Statistical analysis title
    		 Primary efficacy
    Statistical analysis description
    The evaluation of mean change from Baseline in HbA1c compared to Placebo will be done using the Placebo Multiple Imputation (pMI) method followed by analysis using an Analysis of Covariance (ANCOVA) model with Full Analysis Set data.
    Comparison groups
    5-ALA-HCl 150 mg/SFC 118 mg v 5-ALA-HCl 50 mg/SFC 39 mg v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs (TEAEs) were defined as AEs that first occurred or worsened in severity after the first administration of the study medication, until end of the study.
    Adverse event reporting additional description
    An Adverse Event was any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    5-ALA/SFC 150 mg/118 mg
    Reporting group description
    		 -

    Reporting group title
    5-ALA/SFC 50 mg/39 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 5-ALA/SFC 150 mg/118 mg 5-ALA/SFC 50 mg/39 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 72 (4.17%)
    2 / 73 (2.74%)
    2 / 73 (2.74%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 73 (1.37%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 73 (1.37%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oedematous pancreatitis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 73 (1.37%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 5-ALA/SFC 150 mg/118 mg 5-ALA/SFC 50 mg/39 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 72 (63.89%)
    48 / 73 (65.75%)
    44 / 73 (60.27%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 72 (1.39%)
    3 / 73 (4.11%)
    0 / 73 (0.00%)
         occurrences all number
    1
    3
    0
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    2
    0
    2
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    1
    0
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 72 (2.78%)
    2 / 73 (2.74%)
    4 / 73 (5.48%)
         occurrences all number
    2
    2
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    1
    0
    2
    Headache
         subjects affected / exposed
    3 / 72 (4.17%)
    1 / 73 (1.37%)
    0 / 73 (0.00%)
         occurrences all number
    5
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    Sciatica
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 72 (4.17%)
    2 / 73 (2.74%)
    2 / 73 (2.74%)
         occurrences all number
    7
    2
    2
    Muscle spasms
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 72 (1.39%)
    4 / 73 (5.48%)
    3 / 73 (4.11%)
         occurrences all number
    1
    4
    3
    Bronchitis
         subjects affected / exposed
    2 / 72 (2.78%)
    4 / 73 (5.48%)
    1 / 73 (1.37%)
         occurrences all number
    2
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 72 (4.17%)
    2 / 73 (2.74%)
    1 / 73 (1.37%)
         occurrences all number
    4
    2
    1
    Pharyngitis
         subjects affected / exposed
    1 / 72 (1.39%)
    2 / 73 (2.74%)
    1 / 73 (1.37%)
         occurrences all number
    1
    2
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 73 (1.37%)
    2 / 73 (2.74%)
         occurrences all number
    1
    1
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    2 / 73 (2.74%)
         occurrences all number
    0
    2
    2
    Pneumonia
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    Rhinitis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    0
    0
    2
    Viral pharyngitis
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    15 / 72 (20.83%)
    17 / 73 (23.29%)
    18 / 73 (24.66%)
         occurrences all number
    46
    47
    36
    Hypoglycaemia
         subjects affected / exposed
    5 / 72 (6.94%)
    1 / 73 (1.37%)
    2 / 73 (2.74%)
         occurrences all number
    7
    1
    3
    Hyperlipidaemia
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    Hypocalcaemia
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Mar 2018
    Inclusion and exclusion criteria was amended as a result of the feedback received from VHP.

    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
    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.

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